Decree No. 163/2025/ND-CP

DECREE

DETAILING A NUMBER OF ARTICLES AND MEASURES FOR ORGANISING AND GUIDING THE IMPLEMENTATION OF THE LAW ON PHARMACY

Pursuant to the Law on Organisation of the Government dated 18 February 2025;

Pursuant to the Law on Organisation of Local Government dated 16 June 2025;

Pursuant to the Law on Pharmacy dated 06 April 2016; the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy dated 21 November 2024;

At the proposal of the Minister of Health;

The Government promulgates a Decree detailing a number of articles and measures for organising and guiding the implementation of the Law on Pharmacy.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. This Decree details Point d, Clause 26, Article 2; Point b, Clause 2, Article 13; Clause 4, Article 29; Clause 3, Article 34; Clause 5, Article 38; Clause 2, Article 41; Clause 6, Article 54; Clauses 4 and 5, Article 60; and Clause 3, Article 69 of the Law on Pharmacy No. 105/2016/QH13; and Clauses 4, 5 and 9, Points a and c, Clause 18, Points d and dd, Clause 32, Clauses 33, 39 and 43, Article 1 of Law No. 44/2024/QH15 amending and supplementing a number of articles of the Law on Pharmacy No. 105/2016/QH13 (hereinafter collectively referred to as the Law on Pharmacy).

2. Measures for organising and guiding the implementation of the Law on Pharmacy:

a) Management of the import of medicines that do not yet have a medicine circulation registration certificate in Vietnam;

b) Regulations on the remaining shelf life of imported medicines and medicinal ingredients at the time of customs clearance;

c) Regulations on import border gates; requirements for establishments supplying imported medicines and medicinal ingredients; suspension of receipt of dossiers requesting import licences, and suspension of the grant of import licences, for medicines and medicinal ingredients; suspension of import of medicines and medicinal ingredients; regulations on reporting export and import of medicines and medicinal ingredients; regulations on suspending receipt of dossiers for the grant and extension of circulation registration certificates for medicines and medicinal ingredients; suspension of receipt of new dossiers and suspension of settlement of submitted dossiers of establishments requesting confirmation of medicine advertising content;

d) Regulations on specialised papers to be submitted upon customs clearance of exports and imports of medicines and medicinal ingredients.

3. This Decree applies to domestic and foreign agencies, organisations and individuals engaged in pharmacy-related activities in Vietnam.

Chapter II

PHARMACY PRACTISING CERTIFICATES

Section 1. DOSSIERS AND PROCEDURES FOR ISSUING, REISSUING, ADJUSTING THE CONTENT OF, AND REVOKING PHARMACY PRACTISING CERTIFICATES

Article 2. Detailed provisions on dossiers requesting issuance of Pharmacy Practising Certificates

1. The dossier requesting issuance of a Pharmacy Practising Certificate complies with Article 24 of the Law on Pharmacy and is specifically prescribed as follows:

a) The application for a Pharmacy Practising Certificate, made using Form No. 02 in Appendix I issued with this Decree;

b) A certificate of equivalence recognition from the competent authority under Clause 2, Article 12 of this Decree, for professional qualifications issued by foreign training institutions;

c) A certificate confirming practice time, made using Form No. 03 in Appendix I issued with this Decree. Where practice is carried out at multiple establishments, the practice time is the total practice time at those establishments, but a certificate confirming practice time from each establishment is required.

Where a Pharmacy Practising Certificate is requested for different scopes of practice with different requirements for practice time and professional practice establishments, the dossier must include certificates confirming professional practice time and content of professional practice from one or several establishments meeting the requirements of each scope and practice position. Where professional scopes of practice have the same requirements for practice time and professional practice establishments, a separate Certificate for each professional scope of practice is not required;

d) A judicial record is not required to be submitted from the date judicial record data is shared under Clause 5, Article 127 of this Decree.

2. Papers issued by foreign competent authorities must be consularly legalised as prescribed, translated into Vietnamese, and have the translator's signature certified as prescribed.

3. The number of dossiers under this Article is 01 set. Documents specified in Clauses 2, 3, 4, 5 and 7, Article 24 of the Law on Pharmacy must be originals, certified copies, or copies accompanied by the originals for comparison.

Article 3. Detailed provisions on dossiers requesting reissuance of Pharmacy Practising Certificates

1. The dossier requesting reissuance of a Pharmacy Practising Certificate complies with Article 25 of the Law on Pharmacy and is specifically prescribed as follows:

a) The application for reissuance of a Pharmacy Practising Certificate, made using Form No. 04 in Appendix I issued with this Decree;

b) The previously issued Pharmacy Practising Certificate, except where the Pharmacy Practising Certificate has been lost.

2. The number of dossiers under this Article is 01 set. The document specified at Point b, Clause 1 of this Article must be an original, a certified copy, or a copy accompanied by the original for comparison.

Article 4. Detailed provisions on dossiers requesting adjustment of the content of Pharmacy Practising Certificates

1. The dossier requesting adjustment of the content of a Pharmacy Practising Certificate complies with Article 26 of the Law on Pharmacy and is specifically prescribed as follows:

a) The application for adjustment of the content of a Pharmacy Practising Certificate, made using Form No. 05 in Appendix I issued with this Decree;

b) The corresponding professional qualification and the certificate confirming professional practice time at an appropriate pharmaceutical establishment, in the case of a change of the professional scope of practice. For qualifications issued by foreign training institutions, they must be accompanied by a certificate of equivalence recognition from the competent authority under Clause 2, Article 12 of this Decree.

2. The papers specified at Point b, Clause 1 of this Article issued by foreign competent authorities must be consularly legalised as prescribed. These papers must be translated into Vietnamese and have the translator's signature certified as prescribed.

3. The number of dossiers under this Article is 01 set. The document specified at Point b, Clause 1 of this Article and Clauses 2 and 3, Article 26 of the Law on Pharmacy must be originals, certified copies, or copies accompanied by the originals for comparison.

Article 5. Detailed provisions on the procedure for issuing Pharmacy Practising Certificates by examination

1. The person requesting a Pharmacy Practising Certificate submits the dossier directly, via postal services, or online to the Ministry of Health.

2. After receiving the dossier, the Ministry of Health gives the person requesting a Pharmacy Practising Certificate a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree.

3. Where no amendment or supplementation of the dossier is required:

a) The Ministry of Health designates an establishment meeting the requirements in Article 17 of this Decree and convenient for the place of residence of the person requesting the Pharmacy Practising Certificate to organise the examination for issuing the Pharmacy Practising Certificate within 03 working days from the date stated on the Dossier Receipt Slip;

b) The establishment at Point a of this Clause is responsible for organising the examination within 07 working days and sending the examination results to the Ministry of Health within 03 working days from the end of the examination;

c) Where the examination result is satisfactory, within 07 working days from the date of receiving the examination results sent by the examination-organising establishment, the Ministry of Health issues and gives the requester 01 Pharmacy Practising Certificate;

d) Where the examination result is unsatisfactory, within 07 working days from the date of receiving the examination results sent by the examination-organising establishment, the Ministry of Health issues a written notice to the requester, using Form No. 16 in Appendix I issued with this Decree, that no Pharmacy Practising Certificate is issued;

dd) Where a Pharmacy Practising Certificate is issued under Clause 8, Article 24 of the Law on Pharmacy, the Ministry of Health issues the Pharmacy Practising Certificate to the requester within 05 working days from the date stated on the Dossier Receipt Slip without organising an examination.

4. Where amendment or supplementation of the dossier is required, the Ministry of Health issues a written notice of the content of the required amendment or supplementation, using Form No. 16 in Appendix I issued with this Decree, to the requester within 07 working days from the date stated on the Dossier Receipt Slip.

5. After receiving the amended or supplemented dossier, the Ministry of Health gives the requester a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree.

a) Where the amended or supplemented dossier does not meet the requirements, within 07 working days from the date stated on the Receipt Slip for the amended or supplemented dossier, the Ministry of Health issues a written notice to the requester, using Form No. 16 in Appendix I issued with this Decree, that no Pharmacy Practising Certificate is issued;

b) Where no amendment or supplementation of the amended or supplemented dossier is required, the Ministry of Health and the designated examination-organising establishment act under Clause 3 of this Article.

6. Within 06 months from the date the Ministry of Health issues the written notice of amendment or supplementation, the person requesting a Pharmacy Practising Certificate must submit the amended or supplemented dossier as required. After that period, if the requester has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

7. Within 03 working days from the date of issuing a Pharmacy Practising Certificate, the Ministry of Health publishes and updates the following information on the Ministry of Health's web portal:

a) The full name and date of birth of the person issued the Pharmacy Practising Certificate;

b) The number of the Pharmacy Practising Certificate of the person issued the Pharmacy Practising Certificate;

c) The professional scope of practice granted on the Pharmacy Practising Certificate.

8. A Pharmacy Practising Certificate issued by examination is issued using Form No. 07 in Appendix I issued with this Decree.

9. Where a Pharmacy Practising Certificate is issued under Clause 8, Article 24 of the Law on Pharmacy, the person requesting the Pharmacy Practising Certificate does not have to pay a fee.

Article 6. Detailed provisions on the procedure for issuing, reissuing and adjusting the content of Pharmacy Practising Certificates by dossier review

1. The person requesting issuance, reissuance or adjustment of the content of a Pharmacy Practising Certificate submits the dossier directly, via postal services, or online to the Department of Health.

2. After receiving the dossier, the Department of Health gives the person requesting issuance, reissuance or adjustment of the content of a Pharmacy Practising Certificate a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree.

3. Where no amendment or supplementation of the dossier is required, the Department of Health is responsible for:

a) Issuing and giving the requester 01 Pharmacy Practising Certificate within 20 days from the date stated on the Dossier Receipt Slip;

b) Issuing and giving the requester 01 Pharmacy Practising Certificate within 05 working days from the date stated on the Dossier Receipt Slip, where the Pharmacy Practising Certificate was revoked under Clause 3, Article 28 of the Law on Pharmacy;

c) Reissuing or adjusting the content of, and giving the requester, 01 Pharmacy Practising Certificate within 10 days from the date stated on the Dossier Receipt Slip.

4. Where amendment or supplementation of the dossier is required, the Department of Health issues a written notice of the content of the required amendment or supplementation, using Form No. 16 in Appendix I issued with this Decree, to the requester within the following time limits:

a) 07 working days from the date stated on the Dossier Receipt Slip for a dossier requesting issuance of a Pharmacy Practising Certificate;

b) 05 working days from the date stated on the Dossier Receipt Slip for a dossier requesting reissuance or adjustment of the content of a Pharmacy Practising Certificate.

5. After receiving the amended or supplemented dossier, the Department of Health gives the requester a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree.

a) Where the amended or supplemented dossier does not meet the requirements, within 07 working days from the date stated on the Receipt Slip for the amended or supplemented dossier for a dossier requesting issuance of a Pharmacy Practising Certificate, or within 05 working days from the date stated on the Receipt Slip for the amended or supplemented dossier for a dossier requesting reissuance or adjustment of a Pharmacy Practising Certificate, the Department of Health issues a written notice to the requester, using Form No. 16 in Appendix I issued with this Decree, that the Pharmacy Practising Certificate is not issued, reissued or adjusted in content;

b) Where no amendment or supplementation of the amended or supplemented dossier is required, the Department of Health acts under Clause 3 of this Article.

6. Within 06 months from the date the Department of Health issues the written notice of amendment or supplementation, the person requesting issuance, reissuance or adjustment of the content of a Pharmacy Practising Certificate must submit the amended or supplemented dossier as required. After that period, if the requester has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

7. Within 03 working days from the date of issuing, reissuing or adjusting the content of a Pharmacy Practising Certificate, the Department of Health publishes and updates the following information on the Department of Health's web page:

a) The full name and date of birth of the person issued the Pharmacy Practising Certificate;

b) The number of the Pharmacy Practising Certificate of the person issued the Pharmacy Practising Certificate;

c) The professional scope of practice granted on the Pharmacy Practising Certificate.

8. Upon receiving a reissued or content-adjusted Pharmacy Practising Certificate, the person requesting the Pharmacy Practising Certificate must return the previously issued Pharmacy Practising Certificate; except where reissuance is requested because the Certificate was lost, where the original Pharmacy Practising Certificate has been submitted in the dossier requesting reissuance or adjustment of content, and where the previously issued Pharmacy Practising Certificate was issued online.

9. The Pharmacy Practising Certificate returned to the pharmacy practitioner in cases of issuance, reissuance or content adjustment by dossier review is in Form No. 06 in Appendix I issued with this Decree.

10. The Minister of Health prescribes the organisation and operation of the Advisory Council for issuing Pharmacy Practising Certificates.

11. Where a Pharmacy Practising Certificate is issued under Clause 8, Article 24 of the Law on Pharmacy, the person requesting the Pharmacy Practising Certificate does not have to pay a fee.

Article 7. Procedure for revoking Pharmacy Practising Certificates

1. Revocation of Pharmacy Practising Certificates in the cases specified in Clauses 1, 4, 5, 6, 7, 8, 9, 10 and 11, Article 28 of the Law on Pharmacy: Within 05 working days from the date of receiving an inspection or examination conclusion that recommends revoking the Pharmacy Practising Certificate, or upon discovering the cases specified in Clauses 1, 4, 5, 6, 7, 8, 9, 10 and 11, Article 28 of the Law on Pharmacy, the agency that issued the Pharmacy Practising Certificate issues a decision revoking the Pharmacy Practising Certificate within its management competence; where the Pharmacy Practising Certificate is not revoked, a written reply must be given to the agency that recommended revocation, clearly stating the reasons.

2. Revocation of Pharmacy Practising Certificates in the cases specified in Clauses 2 and 3, Article 28 of the Law on Pharmacy: Within 05 working days from the time of discovering that the Pharmacy Practising Certificate was incorrectly written, or receiving a request to revoke the Pharmacy Practising Certificate or a recommendation of incorrect entry from the holder of the Pharmacy Practising Certificate, the agency that issued the Pharmacy Practising Certificate issues a decision revoking the Pharmacy Practising Certificate within its management competence; where the Pharmacy Practising Certificate is not revoked, a written reply must be given to the requesting organisation or individual, clearly stating the reasons.

3. Within 03 working days from the date of issuing the decision revoking the Pharmacy Practising Certificate, the agency issuing the revocation decision is responsible for:

a) Publishing the decision revoking the Pharmacy Practising Certificate on the unit's web portal or web page and sending this decision to the Ministry of Health and other Departments of Health nationwide;

b) Updating the revocation information of the Pharmacy Practising Certificate on the unit's web portal or web page.

4. Within 05 working days from the date of receiving the decision revoking the Pharmacy Practising Certificate from the agency that issued the Pharmacy Practising Certificate, the Ministry of Health is responsible for publishing the decision revoking the Pharmacy Practising Certificate on the Ministry of Health's web portal.

Section 2. TRAINING TO UPDATE PROFESSIONAL KNOWLEDGE IN PHARMACY

Article 8. Establishments training and updating professional knowledge in pharmacy

1. Establishments training and updating professional knowledge in pharmacy include: higher education institutions and vocational education institutions that train in medicine and pharmacy; research institutes with the function of training in medicine and pharmacy; establishments with the function of training health human resources; and pharmacy associations.

2. Establishments training and updating professional knowledge in pharmacy must develop a training programme comprising the following main contents:

a) The training content includes specialised knowledge, law and professional management in pharmacy;

b) Time for training and updating professional knowledge in pharmacy: at least 08 hours.

Article 9. Responsibilities of establishments training and updating professional knowledge in pharmacy

1. To assess and issue certificates of completion of the training programme for updating professional knowledge in pharmacy, using Form No. 08 in Appendix I issued with this Decree.

2. To report to the Department of Health where the establishment is headquartered, and publish on the establishment's web page, the status of starting and ending the establishment's training and updating of professional knowledge in pharmacy; the list of persons issued certificates of completion of training and updating of professional knowledge in pharmacy at the establishment, together with the number and date of issue of the Pharmacy Practising Certificate of those trained and updated; the content of the training and updating programme stated in the certificate of completion, and the date of issuing the certificate.

Article 10. Responsibilities of pharmacy management agencies

1. The Ministry of Health is responsible for inspecting and supervising establishments training and updating professional knowledge in pharmacy under Article 8 of this Decree.

2. The Department of Health is responsible for:

a) Publishing on the Department of Health's web page the operating status of establishments training and updating professional knowledge in pharmacy in the locality;

b) Updating on the Department of Health's web page the list of persons who have completed the training programme for updating professional knowledge in pharmacy at training establishments in the locality;

c) Inspecting, supervising and coordinating with the establishments training and updating professional knowledge in pharmacy in the locality specified in Article 8 of this Decree in organising the training and updating of professional knowledge in pharmacy.

Section 3. STANDARDISATION OF PROFESSIONAL QUALIFICATIONS AND PROFESSIONAL TITLES FOR ISSUING PHARMACY PRACTISING CERTIFICATES

Article 11. Professional qualifications and professional titles eligible for a Pharmacy Practising Certificate

1. A university degree in pharmacy is a university-level degree in pharmacy issued by a domestic educational institution bearing the title “Pharmacist”, “University pharmacist” or “Senior pharmacist”.

2. A university degree in general medicine is a university-level degree in general medicine issued by a domestic educational institution bearing the title “Doctor” or “General practitioner”.

3. A university degree in traditional medicine or traditional pharmacy is a university-level degree in traditional medicine or traditional pharmacy issued by a domestic educational institution.

4. A university degree in biology is a university-level degree in biology issued by a domestic educational institution.

5. A university degree in chemistry is a university-level degree in chemistry issued by a domestic educational institution.

6. A college degree in pharmacy is a college-level degree in pharmacy issued by a domestic educational institution.

7. A secondary-level diploma in pharmacy is a secondary-level diploma in pharmacy issued by a domestic educational institution bearing the title “Intermediate pharmacist” or “Secondary pharmacist” or stating “secondary-level diploma in pharmacy”.

8. A college or secondary-level diploma in medicine is a college- or secondary-level diploma in medicine issued by a domestic educational institution.

9. A secondary-level diploma in traditional medicine or traditional pharmacy is a secondary-level diploma in traditional medicine or traditional pharmacy issued by a domestic educational institution.

10. A primary-level pharmacy qualification or certificate is a certificate or certification issued by a domestic educational institution clearly stating the title “Pharmacy assistant” or “Primary pharmacy”.

Article 12. Determining the scope of practice for qualifications and professional titles not yet determined

1. For qualifications and certificates issued by domestic training institutions whose professional title stated on the qualification does not fall under Clauses 1, 2, 7 and 10 of Article 11 of this Decree, the scope of practice is determined by the agency competent to issue Pharmacy Practising Certificates on the basis of the advice of the Advisory Council for issuing Pharmacy Practising Certificates in the process of considering the issuance of the Pharmacy Practising Certificate.

2. Qualifications and certificates issued by foreign training institutions must be recognised under the regulations of the Minister of Education and Training. Determination of the scope of practice for qualifications and certificates issued by foreign training institutions is carried out under Clause 1 of this Article.

Section 4. PROFESSIONAL PRACTICE IN PHARMACY

Article 13. Professional practice establishments

1. Professional practice establishments are the establishments specified in Clause 2, Article 13 of the Law on Pharmacy, including: pharmaceutical business establishments, pharmacy departments of medical examination and treatment establishments, pharmacy training schools, pharmaceutical research establishments (including establishments researching and developing medicines and medicinal ingredients, establishments researching vaccines and biologicals, medicine information and pharmacovigilance establishments, and establishments researching pharmacology and clinical pharmacy), establishments testing medicines and medicinal ingredients, pharmacy management agencies, or representative offices of foreign traders operating in the pharmaceutical field in Vietnam (hereinafter collectively referred to as pharmaceutical establishments); and medical examination and treatment establishments consistent with the practitioner's specialisation.

2. An appropriate professional practice establishment is a professional practice establishment specified in Clause 1 of this Article whose activities are consistent with the professional practice content of the practitioner specified in Article 14 of this Decree.

3. The professional practice establishment confirms the professional practice time for the person practising at the establishment using Form No. 03 in Appendix I issued with this Decree and is responsible for the confirmed contents.

Article 14. Content of professional practice

1. For the position in charge of pharmaceutical professional matters at establishments producing medicines, active pharmaceutical ingredients, excipients and capsule shells:

a) The person in charge of pharmaceutical professional matters at a medicine-producing establishment, except in the cases specified at Points c and d of this Clause, must practise in one of the following professional contents: producing medicines, testing medicines, researching and developing medicine products, pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school;

b) The person in charge of pharmaceutical professional matters at an establishment producing medicinal ingredients that are active pharmaceutical ingredients, excipients or capsule shells must practise in one of the following professional contents: producing medicines; testing medicines; researching and developing medicine products and medicinal ingredients; producing medicinal ingredients, producing chemicals; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school;

c) The person in charge of pharmaceutical professional matters at an establishment producing vaccines, biologicals and raw materials for producing vaccines and biologicals must practise in one of the following professional contents: producing vaccines and biologicals, controlling vaccines and biologicals, researching and developing vaccine and biological products; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school;

d) The person in charge of pharmaceutical professional matters at a traditional medicine producing establishment must practise in one of the following professional contents: producing and processing traditional medicines, testing traditional medicines, quality assurance, researching and developing traditional medicine products, pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

2. For the position in charge of quality assurance at establishments producing medicines, active pharmaceutical ingredients, excipients and capsule shells:

a) The person in charge of quality assurance at a medicine-producing establishment, except in the case specified at Point c of this Clause, must practise in one of the following professional contents: production, testing, quality assurance, research and product development at a medicine-producing establishment or medicine-testing establishment;

b) The person in charge of quality assurance at an establishment producing medicinal ingredients that are active pharmaceutical ingredients, excipients or capsule shells must practise in one of the following professional contents: production, testing, quality assurance, research and product development at a medicine- or medicinal-ingredient-producing establishment or medicine-testing establishment;

c) The person in charge of quality assurance at an establishment producing vaccines, biologicals and raw materials for producing vaccines and biologicals must practise in one of the following professional contents: production, testing, quality assurance, research and product development at a vaccine or medical biological producing establishment or testing establishment.

3. For the position in charge of pharmaceutical professional matters and the person in charge of quality assurance at establishments producing medicinal herbs:

a) The person in charge of pharmaceutical professional matters and the person in charge of quality assurance at an establishment producing medicinal herbs must practise in one of the following professional contents: producing, compounding and processing herbal medicines, traditional medicines and medicinal herbs, testing medicines, quality assurance in the production process, medicinal ingredients, compounding and processing traditional medicines; pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school;

b) The person in charge of pharmaceutical professional matters and the person in charge of quality assurance at a business household or cooperative producing medicinal herbs must practise in one of the following professional contents: producing medicinal ingredients, testing medicines; quality assurance in the production process, research on medicinal herbs and traditional medicine; compounding and processing traditional medicines; pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

4. For the position in charge of pharmaceutical professional matters at establishments wholesaling medicines and medicinal ingredients:

a) The person in charge of pharmaceutical professional matters at a medicine wholesale establishment, except in the cases specified at Points c and d of this Clause, must practise in one of the following professional contents: wholesaling medicines and medicinal ingredients; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school; registering medicines at a representative office of a foreign trader operating in the pharmaceutical field in Vietnam;

b) The person in charge of pharmaceutical professional matters at an establishment wholesaling medicinal ingredients must practise in one of the following professional contents: producing medicinal ingredients, producing chemicals, testing medicines and medicinal ingredients, research on chemical technology and pharmaceutical technology; wholesaling medicines, exporting and importing medicines; storing medicines and medicinal ingredients; pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school; registering medicines at a representative office of a foreign trader operating in the pharmaceutical field in Vietnam;

c) The person in charge of pharmaceutical professional matters at an establishment wholesaling vaccines and biologicals must practise in one of the following professional contents: producing, wholesaling, storing and testing vaccines and biologicals; research on vaccines and biologicals; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school; registering vaccines and biologicals at a representative office of a foreign trader operating in the pharmaceutical field in Vietnam;

d) The person in charge of pharmaceutical professional matters at an establishment wholesaling medicinal herbs, herbal medicines and traditional medicines must practise in one of the following professional contents: wholesaling medicines and medicinal herbs; services of storing medicines and medicinal herbs; producing medicines, producing medicinal herbs, testing medicines and medicinal ingredients, traditional medicine; research on medicinal herbs and traditional medicine; pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

5. For the position in charge of pharmaceutical professional matters at establishments exporting and importing medicines and medicinal ingredients:

a) The person in charge of pharmaceutical professional matters at an establishment exporting and importing medicines and medicinal ingredients, except in the cases specified at Points b and c of this Clause, must practise in one of the following professional contents: wholesaling medicines; exporting and importing medicines; producing medicines; testing medicines and medicinal ingredients; good storage practice for medicines; pharmacy management relating to circulation of medicines, export, import and wholesale of medicines and medicinal ingredients; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school; registering medicines at a representative office of a foreign trader operating in the pharmaceutical field in Vietnam;

b) The person in charge of pharmaceutical professional matters at an establishment exporting and importing vaccines and biologicals must practise in one of the following professional contents: exporting and importing vaccines and biologicals; producing vaccines and biologicals; wholesaling vaccines and biologicals; providing storage services for vaccines and biologicals; testing vaccines and biologicals; research on vaccines and biologicals; management of vaccines and biologicals; use of vaccines and biologicals; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school; registering vaccines and biologicals at a representative office of a foreign trader operating in the pharmaceutical field in Vietnam;

c) The person in charge of pharmaceutical professional matters at an establishment exporting and importing medicinal herbs, herbal medicines and traditional medicines must practise in one of the following professional contents: wholesaling medicines and medicinal ingredients; storing medicines and medicinal ingredients; producing medicines and medicinal ingredients, testing medicines, medicinal ingredients and traditional medicines; research on medicinal herbs and traditional medicine; pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school; registering medicinal herbs, herbal medicines and traditional medicines at a representative office of a foreign trader operating in the pharmaceutical field in Vietnam.

6. For the position in charge of pharmaceutical professional matters at medicine retail establishments:

a) The person in charge of pharmaceutical professional matters at a pharmacy, medicine counter or commune health station medicine cabinet must practise in one of the following professional contents: wholesaling medicines; retailing medicines; exporting and importing medicines; clinical pharmacy or medicine supply in a medical examination and treatment establishment; producing medicines; testing medicines and medicinal ingredients; pharmaceutical research; storing medicines; distributing medicines; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school;

b) The person in charge of pharmaceutical professional matters at an establishment specialising in retailing medicinal herbs, herbal medicines and traditional medicines, except in the case specified at Point c, Clause 2, Article 13 of the Law on Pharmacy, must practise in one of the professional contents relating to production, research, business, medical examination and treatment by traditional medicine, or pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

7. For the position in charge of pharmaceutical professional matters at establishments providing medicine and medicinal ingredient testing services:

a) The person in charge of pharmaceutical professional matters at an establishment providing medicine and medicinal ingredient testing services, except in the case specified at Point b of this Clause, must practise in one of the following professional contents: testing medicines and medicinal ingredients; research relating to production, testing and analysis of medicines and medicinal ingredients; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school;

b) The person in charge of pharmaceutical professional matters at an establishment providing vaccine and biological testing services must practise in one of the following professional contents: testing medicines, testing medicinal ingredients; controlling vaccines and biologicals; research relating to production and testing of vaccines and biologicals; storing medicines within the scope of vaccines and biologicals; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

8. For the position in charge of pharmaceutical professional matters at establishments providing clinical trial and bioequivalence testing services for medicines, the person must practise in one of the following professional contents: bioequivalence testing of medicines; clinical trials of medicines; testing medicines and medicinal ingredients; pharmacological and clinical pharmacy research; pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

9. For the position in charge of clinical pharmacy work at medical examination and treatment establishments:

a) The person in charge of clinical pharmacy work at a medical examination and treatment establishment, except in the case specified at Point b of this Clause, must practise in one of the following professional contents: bioequivalence testing of medicines; clinical trials of medicines; teaching pharmacology or clinical pharmacy at a pharmacy training school; pharmacological or clinical pharmacy research; pharmacovigilance at a medicine information centre and monitoring of adverse drug reactions; clinical pharmacy at a medical examination and treatment establishment;

b) The person in charge of clinical pharmacy work at a traditional-medicine examination and treatment establishment must practise in one of the following professional contents: clinical trials of medicines; pharmacological and clinical pharmacy research; pharmacovigilance at a medicine information centre and monitoring of adverse drug reactions, practising clinical pharmacy at a traditional-medicine examination and treatment establishment.

10. For the position in charge of pharmaceutical professional matters at establishments providing storage services for medicines and medicinal ingredients:

a) The person in charge of pharmaceutical professional matters at an establishment providing storage services for medicines and medicinal ingredients, except in the case specified at Point b of this Clause, must practise in one of the following professional contents: storing medicines and medicinal ingredients; pharmacy management or traditional medicine and pharmacy management at a pharmacy management agency; teaching a specialised pharmacy subject at a pharmacy training school;

b) The person in charge of pharmaceutical professional matters at an establishment providing storage services for vaccines and biologicals must practise in one of the following professional contents: storing medicines within the scope of vaccines and biologicals; producing vaccines and biologicals; controlling vaccines and biologicals; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

11. For the position in charge of pharmaceutical professional matters at an establishment organising a pharmacy chain: The person in charge of pharmaceutical professional matters at an establishment organising a pharmacy chain must practise in one of the following professional contents: managing the professional activities of the establishment organising the pharmacy chain; wholesaling medicines and medicinal ingredients; pharmacy management at a pharmacy management agency; teaching a specialised subject or pharmacy specialisation orientation at a pharmacy training school.

Article 15. Professional practice time for persons with postgraduate specialist qualifications

1. A person with a postgraduate specialist qualification is a person holding one of the following degrees:

a) Master's degree in pharmacy, medicine, traditional medicine, chemistry or biology (hereinafter referred to as a master's degree);

b) Doctorate in pharmacy, medicine, traditional medicine, chemistry or biology (hereinafter referred to as a doctorate);

c) Specialist level I or specialist level II under the postgraduate specialist training system as prescribed by the Minister of Health.

2. The professional practice time at an appropriate pharmaceutical establishment prescribed in Articles 15, 16, 17, 17a, 18, 19, 20, 21 and 22 of the Law on Pharmacy is reduced by:

a) 3/4 of the time for persons with a doctorate or specialist level II;

b) 1/2 of the time for persons with a master's degree or specialist level I.

Section 5. EXAMINATION FOR ISSUING PHARMACY PRACTISING CERTIFICATES

Article 16. Form, content and programme of the examination

1. Form of examination: centralised examination at the examination-organising establishment or online examination.

2. The examination content includes:

a) General knowledge for pharmacy practitioners;

b) Specialised knowledge appropriate to the job position that must have a Pharmacy Practising Certificate under Article 11 of the Law on Pharmacy.

3. The Minister of Health specifically prescribes the regulation, examination content, examination question bank and passing score scale for issuing Pharmacy Practising Certificates.

Article 17. Requirements for establishments organising examinations for issuing Pharmacy Practising Certificates

Must be one of the university or postgraduate training institutions in pharmacy or in traditional medicine and pharmacy.

Article 18. Examination costs

Persons sitting the examination for issuance of a Pharmacy Practising Certificate must pay the examination costs under law.

Chapter III

PHARMACEUTICAL BUSINESS

Section 1. CERTIFICATES OF ELIGIBILITY FOR PHARMACEUTICAL BUSINESS

Article 19. Conditions for traditional medicine business

1. Establishments producing traditional medicines for nationwide circulation must meet Points a, c and d, Clause 2, Article 69 of the Law on Pharmacy.

2. Establishments exporting and importing traditional medicines must have facilities, professional and technical documents, and personnel meeting Good Storage Practice for medicines. The person in charge of pharmaceutical professional matters at an establishment exporting and importing traditional medicines is as prescribed in Clause 3, Article 17 of the Law on Pharmacy.

3. Establishments providing storage services for traditional medicines must have facilities, professional and technical documents, and personnel meeting Good Storage Practice for medicines. The person in charge of pharmaceutical professional matters at an establishment providing storage services for traditional medicines is as prescribed in Clause 1, Article 22 of the Law on Pharmacy.

4. Establishments wholesaling traditional medicines must have facilities, professional and technical documents, and personnel meeting Good Distribution Practice for medicines. The person in charge of pharmaceutical professional matters at an establishment wholesaling traditional medicines is as prescribed in Clause 3, Article 16 of the Law on Pharmacy.

5. Conditions for establishments specialising in retailing medicinal herbs, herbal medicines and traditional medicines:

a) The person in charge of pharmaceutical professional matters at an establishment retailing medicinal herbs, herbal medicines and traditional medicines is as prescribed in Clause 4, Article 18 of the Law on Pharmacy;

b) Have a fixed, separate location; solidly built; with an area consistent with the business scale; arranged in a high, well-ventilated and safe place away from pollution sources;

c) Must have a storage area and storage equipment consistent with the storage requirements stated on the label.

Toxic medicinal herbs must be displayed for sale (if any) and stored in a separate area; where displayed and stored in the same area as other medicinal herbs, they must be kept separate and clearly marked “toxic medicinal herbs” to avoid confusion.

An establishment specialising in retailing herbal medicines and traditional medicines, or specialising in retailing medicinal herbs, needs only a corresponding storage area for storing herbal medicines and traditional medicines or for storing medicinal herbs and traditional medicine ingredients;

d) Tools and packaging in direct contact with herbal medicines, traditional medicines and medicinal herbs must not affect the quality of the herbal medicines, traditional medicines and medicinal herbs;

dd) Have record books or appropriate measures for retaining information on receipts and issues and traceability;

e) A person retailing medicinal herbs, herbal medicines and traditional medicines must hold one of the qualifications specified at Points a, c, e, g, i or l, Clause 1, Article 13 of the Law on Pharmacy.

For toxic medicinal herbs, prescription herbal medicines and prescription traditional medicines, the person directly retailing and advising the buyer must be the person in charge of professional matters of the retail establishment;

g) Where the retail establishment also trades in other goods as permitted by law, those goods must be displayed and stored in a separate area and must not affect medicinal herbs, herbal medicines and traditional medicines.

Article 20. Detailed provisions on dossiers requesting issuance, reissuance and adjustment of Certificates of Eligibility for Pharmaceutical Business

The dossier requesting issuance, reissuance and adjustment of a Certificate of Eligibility for Pharmaceutical Business complies with Article 38 of the Law on Pharmacy and is specifically prescribed as follows:

1. The application for issuance, reissuance and adjustment of the Certificate of Eligibility for Pharmaceutical Business, using Forms No. 10, 11 and 12 in Appendix I issued with this Decree.

2. The technical documents specified at Point b, Clause 1, Article 38 of the Law on Pharmacy include the following:

a) For establishments producing medicines and medicinal ingredients: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Manufacturing Practice for medicines and medicinal ingredients.

Where the establishment requests a Certificate of Eligibility for Business with the scope of producing medicines and medicinal ingredients, including selling or delivering medicines and medicinal ingredients it produces to wholesale and retail establishments and medical examination and treatment establishments, it must additionally have professional and technical documents and personnel under the principles and standards of Good Distribution Practice for medicines and medicinal ingredients, except for delivery at that production establishment's warehouse;

b) For establishments importing medicines and medicinal ingredients, exporting medicines and medicinal ingredients, and providing storage services for medicines and medicinal ingredients: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Storage Practice for medicines and medicinal ingredients;

c) For establishments wholesaling medicines and medicinal ingredients: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Distribution Practice for medicines and medicinal ingredients;

d) For establishments retailing medicines: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Pharmacy Practice.

For establishments specialising in retailing medicinal herbs, herbal medicines and traditional medicines: Documents proving compliance with Clause 5, Article 19 of this Decree, as prescribed by the Minister of Health;

dd) For establishments providing medicine and medicinal ingredient testing services: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Laboratory Practice for medicine quality control;

e) For establishments providing clinical trial services for medicines: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Clinical Practice;

g) For establishments providing bioequivalence testing services for medicines: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Laboratory Practice for the biological fluid analysis stage and Good Clinical Practice for the clinical research stage.

Where an establishment providing bioequivalence testing services signs a contract or links with a clinical trial establishment meeting Good Clinical Practice to carry out the clinical research stage in bioequivalence testing of medicines, the technical documents are not required to include documents on facilities, professional and technical documents and personnel under the principles and standards of Good Clinical Practice;

h) For establishments organising a pharmacy chain: Documents on facilities, professional and technical documents and personnel under the principles and standards of Good Distribution Practice for medicines and medicinal ingredients.

3. The technical documents specified at Point b, Clause 2, Article 38 of the Law on Pharmacy include documents on facilities, professional and technical documents and personnel under Clause 2 of this Article corresponding to the changed business conditions.

4. The number of dossiers under this Article is 01 set. The documents submitted in the dossier requesting issuance, reissuance and adjustment of the Certificate of Eligibility for Pharmaceutical Business specified at Points c and d, Clause 1, Points c and d, Clause 2, and Points b and c, Clause 4, Article 38 of the Law on Pharmacy are originals, certified copies, or copies accompanied by the originals for comparison.

Article 21. Order and procedures for issuing Certificates of Eligibility for Pharmaceutical Business

1. The establishment requesting a Certificate of Eligibility for Pharmaceutical Business submits the dossier directly, via postal services, or online to:

a) The Ministry of Health, in the case of requesting a Certificate of Eligibility for Pharmaceutical Business in one of the cases specified at Points a, b, c, e, g, h and i, Clause 2, Article 32 of the Law on Pharmacy;

b) The Department of Health where the establishment has its business location, in the case of requesting a Certificate of Eligibility for Pharmaceutical Business in one of the cases specified at Points d and dd, Clause 2, Article 32 of the Law on Pharmacy.

2. After receiving the dossier, the agency receiving the dossier gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree.

3. The agency receiving the dossier:

a) Issues the Certificate of Eligibility for Pharmaceutical Business within 30 days from the date stated on the Dossier Receipt Slip, where the facilities, technical conditions and personnel have been inspected and assessed as meeting Good Practice consistent with the business scope, without having to organise an on-site assessment at the establishment requesting the Certificate of Eligibility for Pharmaceutical Business;

b) Organises an on-site assessment at the establishment requesting the Certificate of Eligibility for Pharmaceutical Business within 20 days from the date stated on the Dossier Receipt Slip.

4. Where amendment or supplementation of the dossier is required in the case specified at Point a, Clause 3 of this Article, within 07 working days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a document to the requesting establishment, which must specifically state the documents and contents to be amended or supplemented, using Form No. 16 in Appendix I issued with this Decree.

5. After receiving the amended or supplemented dossier, the agency receiving the dossier gives the requesting establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree.

a) Where the amended or supplemented dossier does not meet the requirements, within 10 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a written notice to the establishment that the Certificate of Eligibility for Pharmaceutical Business is not issued, using Form No. 16 in Appendix I issued with this Decree;

b) Where no amendment or supplementation of the amended or supplemented dossier is required, the agency receiving the dossier acts under Point a, Clause 3 of this Article.

6. After the on-site assessment of the establishment under Point b, Clause 3 of this Article, the agency issuing the Certificate of Eligibility for Pharmaceutical Business is responsible for:

a) Issuing the Certificate of Eligibility for Pharmaceutical Business within 10 days from the date of completing the on-site assessment, where no remedial or corrective action is required;

b) Issuing a written notice that the establishment is not issued the Certificate of Eligibility for Pharmaceutical Business, where the establishment does not meet the prescribed conditions, or a written notice of the contents to be remedied or corrected, using Form No. 16 in Appendix I issued with this Decree, within 10 days from the date of completing the on-site assessment, where remedial or corrective action is required.

7. Within 20 days from the date of receiving the establishment's report on completing the remedial or corrective action together with supporting documents, the agency receiving the dossier issues the Certificate of Eligibility for Pharmaceutical Business or issues a written notice of amendment or supplementation.

8. Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation or the written notice of the contents to be remedied or corrected, the requesting establishment must submit the amended or supplemented dossier as required, or report on completion of the remedial or corrective action together with supporting documents. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

9. Within 03 working days from the date of issuing the Certificate of Eligibility for Pharmaceutical Business, the agency receiving the dossier publishes and updates the following information on the web portal or web page of the issuing agency:

a) The name and address of the establishment issued the Certificate of Eligibility for Pharmaceutical Business;

b) The full name of the person in charge of pharmaceutical professional matters and the number of the Pharmacy Practising Certificate;

c) The number of the Certificate of Eligibility for Pharmaceutical Business;

d) The scope of pharmaceutical business.

10. Upon receiving a Certificate of Eligibility for Pharmaceutical Business issued in the cases of issuance under Point b, Clause 1, Article 36 of the Law on Pharmacy, the establishment must return the previously issued Certificate of Eligibility for Pharmaceutical Business, except where the Certificate of Eligibility for Pharmaceutical Business has been lost or was issued online.

11. The agency receiving the dossier issues 01 Certificate of Eligibility for Pharmaceutical Business, using Form No. 13 in Appendix I issued with this Decree, to the requesting establishment.

12. Where the establishment has been assessed as meeting Good Practice, the agency receiving the dossier issues a Good Practice certificate if the establishment requests a Good Practice certificate.

Article 22. Order and procedures for reissuing and adjusting Certificates of Eligibility for Pharmaceutical Business

1. The establishment requesting reissuance or adjustment of a Certificate of Eligibility for Pharmaceutical Business submits the dossier directly, via postal services, or online to:

a) The Ministry of Health, in the case of requesting reissuance or adjustment of a Certificate of Eligibility for Pharmaceutical Business in one of the cases specified at Points a, b, c, e, g, h and i, Clause 2, Article 32 of the Law on Pharmacy;

b) The Department of Health where the establishment has its business location, in the case of requesting reissuance or adjustment of a Certificate of Eligibility for Pharmaceutical Business in one of the cases specified at Points d and dd, Clause 2, Article 32 of the Law on Pharmacy.

2. After receiving the dossier, the agency receiving the dossier gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree.

3. Where no amendment or supplementation of the dossier is required, the agency reissuing or adjusting the Certificate of Eligibility for Pharmaceutical Business is responsible for:

a) Reissuing or adjusting the Certificate of Eligibility for Pharmaceutical Business within 20 days from the date stated on the Dossier Receipt Slip, in the cases specified at Point a, Clause 2 and Clause 3, Article 36 of the Law on Pharmacy;

b) Reissuing the Certificate of Eligibility for Pharmaceutical Business within 07 working days from the date stated on the Dossier Receipt Slip, in the case specified at Point b, Clause 2, Article 36 of the Law on Pharmacy.

4. Where amendment or supplementation of the dossier is required, the agency receiving the dossier must issue a written notice to the establishment requesting amendment or supplementation of the dossier requesting reissuance or adjustment of the Certificate of Eligibility for Pharmaceutical Business within 05 working days from the date stated on the Dossier Receipt Slip, using Form No. 16 in Appendix I issued with this Decree.

5. After receiving the amended or supplemented dossier, the agency receiving the dossier gives the establishment submitting the amended or supplemented dossier a Receipt Slip using Form No. 01 in Appendix I issued with this Decree.

a) Where the amended or supplemented dossier does not meet the requirements, within 05 working days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a written notice to the establishment that the Certificate of Eligibility for Pharmaceutical Business is not reissued or adjusted, using Form No. 16 in Appendix I issued with this Decree;

b) Where no amendment or supplementation is required, the agency receiving the dossier reissues or adjusts the Certificate of Eligibility for Pharmaceutical Business under Clause 3 of this Article.

6. Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation, the requesting establishment must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

7. Within 03 working days from the date of reissuing or adjusting the Certificate of Eligibility for Pharmaceutical Business, the agency receiving the dossier publishes and updates the following information on the web portal or web page of the issuing agency:

a) The name and address of the establishment whose Certificate of Eligibility for Pharmaceutical Business is reissued or adjusted;

b) The full name of the person in charge of pharmaceutical professional matters and the number of the Pharmacy Practising Certificate;

c) The number of the Certificate of Eligibility for Pharmaceutical Business;

d) The scope of pharmaceutical business.

8. Upon receiving a new Certificate of Eligibility for Pharmaceutical Business, the establishment must return the previously issued Certificate of Eligibility for Pharmaceutical Business, except where the Certificate of Eligibility for Pharmaceutical Business has been lost or was issued online.

9. The agency reissuing or adjusting the Certificate of Eligibility for Pharmaceutical Business issues 01 Certificate of Eligibility for Pharmaceutical Business, using Form No. 13 in Appendix I issued with this Decree, to the establishment requesting reissuance or adjustment.

Article 23. Procedures for revoking Certificates of Eligibility for Pharmaceutical Business

1. Within 05 working days from the date of receiving an inspection or examination conclusion that recommends revoking a Certificate of Eligibility for Business, or upon discovering a case specified in Article 40 of the Law on Pharmacy, the agency issuing the Certificate of Eligibility for Pharmaceutical Business must issue a decision revoking the Certificate of Eligibility for Pharmaceutical Business within its management competence; where it does not revoke, it must reply in writing to the agency that recommended revocation, stating the reasons clearly.

2. Within 03 working days from the date of issuing the decision revoking the Certificate of Eligibility for Pharmaceutical Business, the agency issuing the revocation decision is responsible for:

a) Posting the decision revoking the Certificate of Eligibility for Pharmaceutical Business on its web portal or web page and sending this decision to the Ministry of Health and the other Departments of Health nationwide;

b) Updating the information on revocation of the Certificate of Eligibility for Pharmaceutical Business on its web portal or web page.

3. Within 05 working days from the date of receiving the decision revoking the Certificate of Eligibility for Pharmaceutical Business, the Ministry of Health is responsible for posting this decision on the web portal of the Ministry of Health.

Section 2. AREAS AND BUSINESS SCOPE OF RETAIL ESTABLISHMENTS THAT ARE PHARMACY COUNTERS AND MEDICINE CABINETS

Article 24. Areas for opening pharmacy counters and commune health station medicine cabinets

1. Areas for opening pharmacy counters:

a) Communes and special zones on islands;

b) Areas newly converted from communes or special zones on islands into wards: if at the time of conversion there is not yet one medicine retail establishment serving every 2,000 residents, new pharmacy counters may continue to be opened, and such pharmacy counters are permitted to operate for no more than 03 years from the date the area is converted;

c) Pharmacy counters not in an area specified at Point a of this Clause that were issued a Certificate of Eligibility for Pharmaceutical Business before the date the area was converted into a ward are permitted to operate for no more than 03 years from the date the area is converted.

2. Areas for opening commune health station medicine cabinets:

Health stations of communes and special zones on islands.

Article 25. Business scope of pharmacy counters and commune health station medicine cabinets

1. The business scope of a pharmacy counter is as prescribed at Point b, Clause 1, Article 48 of the Law on Pharmacy.

2. The business scope of a commune health station medicine cabinet is as prescribed at Point b, Clause 1, Article 49 of the Law on Pharmacy.

Section 3. ORGANISATION OF MOBILE MEDICINE RETAIL

Article 26. Conditions for mobile medicine retail

1. Establishments organising mobile medicine retail include:

a) Medicine manufacturing establishments;

b) Medicine wholesale establishments;

c) Medicine retail establishments;

d) Medical establishments of the people's armed forces and military-civilian medical examination and treatment establishments that supply medicines in ethnic minority areas, mountainous areas, islands, areas with difficult socio-economic conditions, and areas with especially difficult socio-economic conditions;

dd) Establishments organising a pharmacy chain.

2. A person conducting mobile medicine retail must be an employee of an establishment specified in Clause 1 of this Article and hold one of the professional qualifications specified at Points a, b, c, e, g, h, i and k, Clause 1, Article 13 of the Law on Pharmacy.

3. Medicines sold through mobile retail must have a remaining shelf life of at least 06 months and be stored in hygienic means and equipment that avoid exposure to rain and sun.

4. At the place of mobile medicine retail, there must be a sign clearly stating the name and address of the establishment organising the mobile medicine retail, the seller's full name, and the area of operation.

Article 27. List of medicines and areas for mobile medicine retail

1. The list of medicines for mobile retail consists of medicines meeting the following criteria:

a) Being on the list of non-prescription medicines;

b) Medicines requiring storage only under normal conditions;

c) Meeting the ordinary needs of local people, with priority given to medicinal herbs cultivated or harvested in ethnic minority areas.

2. Based on the criteria specified in Clause 1 of this Article, the Department of Health announces the list of medicines and the areas permitted for mobile medicine retail in its locality.

Article 28. Procedures for notifying mobile medicine retail activities

1. Before organising mobile medicine retail, the establishment organising mobile medicine retail is responsible for giving written notice, using Form No. 14 in Appendix I issued with this Decree, to the Department of Health of the locality where the mobile medicine retail activities are expected to take place.

2. Within 03 working days from the date of receiving the notice from the establishment organising mobile medicine retail, the Department of Health is responsible for publishing information on the establishment organising mobile medicine retail on the web page of the Department of Health and for organising supervision and inspection.

Section 4. SECURITY MEASURES, MEASURES TO ENSURE NO LOSS OF SPECIALLY CONTROLLED MEDICINES AND MEDICINAL INGREDIENTS, AND ORDER AND PROCEDURES FOR PERMITTING BUSINESS IN SPECIALLY CONTROLLED MEDICINES AND MEDICINES ON THE LIST OF RESTRICTED-RETAIL MEDICINES

Article 29. List of medicinal ingredients that are radioactive substances and list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields

1. The list of medicinal ingredients that are radioactive substances is issued in Appendix IV issued with this Decree.

2. Announcement of the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields:

a) The Ministry of Agriculture and Environment, the Ministry of Industry and Trade, the Ministry of Construction and other ministries and ministerial-level agencies that issue or amend and supplement lists of substances prohibited from use in sectors and fields within their management scope are responsible for sending the lists to the Ministry of Health;

b) After receiving the lists of prohibited substances issued and sent by the ministries and ministerial-level agencies specified at Point a of this Clause, the Ministry of Health reviews the substances that are medicines or active pharmaceutical ingredients in order to issue a decision on the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields, and announces it on the web portal of the Ministry of Health.

Article 30. Security measures and measures to ensure no loss of specially controlled medicines and medicinal ingredients

1. Establishments trading in specially controlled medicines must comply with Articles 31, 32, 33, 34, 35 and 36 of this Decree.

2. In the case of trading in radioactive medicines, in addition to meeting Clause 1 of this Article, the establishment must also comply with the Law on Atomic Energy and other relevant legal documents.

3. The Ministry of Health and the Departments of Health, once every 03 years or on an ad hoc basis, inspect and assess the compliance of establishments trading in specially controlled medicines with the security measures prescribed in this Section, under regulations of the Minister of Health or international treaties to which the Socialist Republic of Vietnam is a party.

Article 31. Provisions on facilities of establishments trading in specially controlled medicines

1. For establishments producing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines:

a) Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines. This warehouse or area must have a door with a firm lock;

b) Have a camera system monitoring each stage of the production and storage of medicines and medicinal ingredients;

c) Have a management and monitoring system using records and books as prescribed by the Minister of Health.

2. For establishments producing combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors:

a) Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines. This warehouse or area must have a door with a firm lock;

b) Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors. The warehouse must have a door with a firm lock;

c) Have a camera system monitoring each stage of the production and storage of medicines and medicinal ingredients;

d) Have a management and monitoring system using records and books as prescribed by the Minister of Health.

3. For establishments producing radioactive medicines:

a) Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing radioactive medicines;

b) Have a management and monitoring system using records and books as prescribed by the Minister of Health;

c) Have a camera system in the areas for producing and storing medicines.

4. For establishments exporting, importing, or providing storage services for narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines:

a) Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines. This warehouse or area must have a door with a firm lock;

b) Have a camera system in the warehouse for storing medicines and medicinal ingredients;

c) Have a management and monitoring system using records and books as prescribed by the Minister of Health.

5. For establishments exporting, importing, wholesaling, or providing storage services for combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors: Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors. The warehouse must have a door with a firm lock; and have a management and monitoring system using records and books as prescribed by the Minister of Health.

6. For establishments exporting, importing, or wholesaling radioactive medicines and medicinal ingredients that are radioactive substances: Have a management and monitoring system using records and books as prescribed by the Minister of Health.

7. For establishments wholesaling narcotic medicines, psychotropic medicines, and precursor medicines:

a) Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing narcotic medicines, psychotropic medicines, and precursor medicines. The separate warehouse or area must have a door with a firm lock;

b) Have a camera system in the medicine storage area;

c) Have a management and monitoring system using records and books as prescribed by the Minister of Health.

8. For establishments retailing narcotic medicines, psychotropic medicines, and precursor medicines:

a) Narcotic medicines, psychotropic medicines, and precursor medicines must be stored in a separate cabinet or separate compartment with a firm lock;

b) Have a management and monitoring system using records and books as prescribed by the Minister of Health.

9. Establishments retailing combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors must monitor them using a software system or records and books as prescribed by the Minister of Health.

10. For establishments retailing radioactive medicines:

a) Have a separate area for storing radioactive medicines;

b) Have a management and monitoring system using records and books as prescribed by the Minister of Health.

11. For establishments providing clinical trial services for medicines, bioequivalence testing services for medicines, testing services, or storage services for radioactive medicines:

a) Have a separate warehouse or separate area meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients for storing radioactive medicines; have a management and monitoring system using records and books as prescribed by the Minister of Health; and have a camera system for establishments providing storage services for radioactive medicines;

b) Have a management and monitoring system using records and books as prescribed by the Minister of Health;

c) Have a camera system for establishments providing storage services for radioactive medicines.

12. Establishments providing clinical trial services for medicines, bioequivalence testing services for medicines, or testing services for specially controlled medicines, except the cases specified in Clause 11 of this Article, must store narcotic medicines, psychotropic medicines, precursor medicines, medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, and combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors, in a separate area with a firm lock or in a separate cabinet or compartment with a firm lock.

13. Establishments trading in toxic medicines, toxic medicinal ingredients, and medicines and active pharmaceutical ingredients on the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields must monitor the entire process of issuing, receiving and stock using a software system or records and books as prescribed by the Minister of Health.

Article 32. Provisions on personnel of establishments trading in specially controlled medicines

1. For establishments producing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines:

a) The storekeeper storing narcotic medicines and medicinal ingredients that are narcotic active pharmaceutical ingredients must hold a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment;

b) The storekeeper storing psychotropic medicines, precursor medicines, and medicinal ingredients that are psychotropic active pharmaceutical ingredients or precursors used as medicines must hold an intermediate degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment.

2. For establishments producing combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors:

a) The storekeeper storing medicinal ingredients that are narcotic active pharmaceutical ingredients must hold a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment;

b) The storekeeper storing medicinal ingredients that are psychotropic active pharmaceutical ingredients or precursors used as medicines must hold an intermediate degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment.

3. For establishments producing radioactive medicines:

a) The medicine storekeeper must hold an intermediate degree in pharmacy or higher, or a bachelor's degree in radiochemistry, or a bachelor's degree in radiation medicine or nuclear medicine or higher;

b) The person responsible for supervising the research, production, analysis and testing process must hold a bachelor's degree in radiochemistry or radiation medicine or nuclear medicine, or hold a university degree in pharmacy or higher.

4. For establishments exporting or importing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines: The storekeeper storing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines must hold a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment.

5. For establishments wholesaling narcotic medicines, psychotropic medicines, and precursor medicines:

a) The storekeeper storing narcotic medicines must hold a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment;

b) The storekeeper storing psychotropic medicines and precursor medicines must hold an intermediate degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment.

6. For establishments retailing narcotic medicines, psychotropic medicines, and precursor medicines:

a) The person responsible for retailing narcotic medicines must hold a university degree in pharmacy or higher;

b) The person responsible for retailing psychotropic medicines and precursor medicines must hold an intermediate degree in pharmacy or higher.

7. For establishments retailing radioactive medicines: The person responsible for retail must hold an intermediate degree in pharmacy or higher.

8. For establishments providing storage services for narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines: The storekeeper storing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines must hold a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business establishment.

9. For establishments providing clinical trial services for medicines, bioequivalence testing services for medicines, or testing services for narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines: The person monitoring and managing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines must hold an intermediate degree in pharmacy or higher.

10. For establishments providing clinical trial services for medicines, bioequivalence testing services for medicines, testing services, or storage services for radioactive medicines:

a) The medicine storekeeper must hold an intermediate degree in pharmacy or higher, or a bachelor's degree in radiochemistry, or a bachelor's degree in radiation medicine or nuclear medicine or higher; the person responsible for supervising the research, production, analysis and testing process must hold a bachelor's degree in radiochemistry or radiation medicine or nuclear medicine or higher, or hold a university degree in pharmacy or higher;

b) The person responsible for supervising the research, production, analysis and testing process must hold a bachelor's degree in radiochemistry or radiation medicine or nuclear medicine or higher, or hold a university degree in pharmacy or higher.

Article 33. Provisions on delivery, receipt and transport of medicines and medicinal ingredients by establishments trading in specially controlled medicines

1. Persons delivering and receiving specially controlled medicines and medicinal ingredients must hold an intermediate degree in pharmacy or higher; in the case of delivery and receipt of radioactive medicines, the persons delivering and receiving radioactive medicines must additionally hold a radiation safety certificate under the law on atomic energy.

2. A person transporting narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines must, when performing the task, carry the assignment document from the head of the establishment, valid identification papers, and a sales invoice or warehouse issue slip. In the case of transporting radioactive medicines, the transporter must additionally carry a radiation safety certificate.

3. When delivering and receiving narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, a delivery and receipt record must be made under Form No. 01 in Appendix II issued with this Decree.

4. Medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, and narcotic medicines, psychotropic medicines, and precursor medicines must be kept secure during transport to avoid loss. In the case of transporting radioactive medicines, radiation safety must be ensured in accordance with the regulations and guidance on safe transport of radioactive materials under the law on atomic energy.

5. Establishments participating in the delivery and receipt of radioactive medicines must hold a licence for conducting radiation work within the scope of transport of radioactive sources under the law on atomic energy.

Article 34. Provisions on purchase and sale of specially controlled medicines

1. For medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines:

a) A medicine manufacturing establishment may import ingredients only to serve its own medicine production activities;

b) An importing establishment may sell imported ingredients nationwide only to the following establishments: medicine manufacturing establishments, to serve medicine production at the establishment itself; medical examination and treatment establishments, to compound medicines to meet the establishment's treatment needs; State medicine and medicinal ingredient testing establishments, to serve the establishment's testing of medicines and medicinal ingredients and for research and establishment of standards serving research and testing of medicines and medicinal ingredients; science and technology organisations, to serve the establishment's research activities; training establishments with pharmacy-related research and teaching activities, to serve the establishment's research and teaching activities;

c) A medicine manufacturing establishment that does not use up its ingredients may transfer them to another manufacturing establishment when permitted in writing by the Ministry of Health under Article 39 of this Decree.

2. Sale of narcotic medicines, psychotropic medicines, precursor medicines, and combination medicines containing precursors by medicine manufacturing establishments:

a) The establishment may sell medicines it produces nationwide to: an establishment that holds both a Certificate of Eligibility for Pharmaceutical Business covering the scope of exporting and importing medicines and a Certificate of Eligibility for Pharmaceutical Business covering the scope of wholesaling medicines; pharmacies; establishments providing clinical trial services for medicines, to serve clinical trial activities at the establishment; establishments providing bioequivalence testing services, to serve bioequivalence testing activities at the establishment; establishments providing testing services for medicines and medicinal ingredients and State medicine and medicinal ingredient testing establishments, to serve testing of medicines and medicinal ingredients at the establishment; medical examination and treatment establishments, vaccination establishments, other medical establishments and drug rehabilitation establishments, to serve medical examination and treatment at the establishment; science and technology organisations, to serve the establishment's research activities; training establishments with pharmacy-related research and teaching activities, to serve the establishment's research and teaching activities;

b) The establishment may select only 01 medicine wholesale establishment in each province to sell all the products it manufactures.

3. Sale of narcotic medicines, psychotropic medicines, precursor medicines, and combination medicines containing precursors by medicine importing establishments:

a) The establishment may sell medicines it imports nationwide to: pharmacies; establishments providing clinical trial services for medicines, to serve clinical trial activities at the establishment; establishments providing bioequivalence testing services, to serve bioequivalence testing activities at the establishment; establishments providing testing services for medicines and medicinal ingredients and State medicine and medicinal ingredient testing establishments, to serve testing of medicines and medicinal ingredients at the establishment; medical examination and treatment establishments, vaccination establishments, other medical establishments and drug rehabilitation establishments, to serve medical examination and treatment at the establishment; science and technology organisations, to serve the establishment's research activities; training establishments with pharmacy-related research and teaching activities, to serve the establishment's research and teaching activities;

b) The establishment may select only 01 medicine wholesale establishment in each province to sell all the products it imports;

c) A medicine importing establishment with foreign investment capital may sell medicines only under Point b of this Clause.

4. Sale of narcotic medicines, psychotropic medicines, precursor medicines, and combination medicines containing precursors by an establishment that holds both a Certificate of Eligibility for Pharmaceutical Business covering the scope of exporting and importing medicines and a Certificate of Eligibility for Pharmaceutical Business covering the scope of wholesaling medicines:

a) The establishment may sell medicines it trades in nationwide to: pharmacies and other establishments that hold both a Certificate of Eligibility for Pharmaceutical Business covering the scope of exporting and importing medicines and a Certificate of Eligibility for Pharmaceutical Business covering the scope of wholesaling medicines; establishments providing clinical trial services for medicines, to serve clinical trial activities at the establishment; establishments providing bioequivalence testing services, to serve bioequivalence testing activities at the establishment; establishments providing testing services for medicines and medicinal ingredients and State medicine and medicinal ingredient testing establishments, to serve testing of medicines and medicinal ingredients at the establishment; medical examination and treatment establishments, vaccination establishments, other medical establishments and drug rehabilitation establishments, to serve medical examination and treatment at the establishment; science and technology organisations, to serve the establishment's research activities; training establishments with pharmacy-related research and teaching activities, to serve the establishment's research and teaching activities;

b) The establishment may select only 01 medicine wholesale establishment in each province to sell all the products it trades in.

5. A medicine wholesale establishment may sell narcotic medicines, psychotropic medicines, precursor medicines, and combination medicines containing precursors only to establishments in the province where the wholesale establishment has its business location, including:

a) Medicine retail establishments;

b) Establishments providing clinical trial services for medicines, to serve clinical trial activities at the establishment;

c) Establishments providing bioequivalence testing services, to serve bioequivalence testing activities at the establishment;

d) Establishments providing testing services for medicines and medicinal ingredients and State medicine and medicinal ingredient testing establishments, to serve testing of medicines and medicinal ingredients at the establishment;

dd) Medical examination and treatment establishments, vaccination establishments, other medical establishments and drug rehabilitation establishments, to serve medical examination and treatment at the establishment;

e) Science and technology organisations, to serve the establishment's research activities; training establishments with pharmacy-related research and teaching activities, to serve the establishment's research and teaching activities.

6. The purchase and sale of medicines and medicinal ingredients between the establishments specified in Clauses 1, 2, 3, 4 and 5 of this Article is carried out under an Order approved by the competent authority, except for the purchase of medicines in the following cases:

a) Purchase of medicines under bidding results approved by the provincial People's Committee of the locality where the medical examination and treatment establishment, vaccination establishment, other medical establishment or drug rehabilitation establishment is located;

b) Purchase of medicines under bidding results approved by the Ministry of National Defence for establishments under the Ministry of National Defence;

c) Purchase of medicines under bidding results approved by the Ministry of Public Security for establishments under the Ministry of Public Security.

7. Combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, radioactive medicines, medicinal ingredients that are radioactive substances, toxic medicines, toxic medicinal ingredients, and medicines and active pharmaceutical ingredients on the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields of medicine and medicinal ingredient trading establishments are purchased and sold under Chapter IV of the Law on Pharmacy.

8. Where there is no retail establishment for specially controlled medicines in the locality, the provincial People's Committee is responsible for designating a medical examination and treatment establishment to transfer specially controlled medicines to ensure sufficient medicines for patients.

Article 35. Provisions on the reporting regime for specially controlled medicines

1. For manufacturing, exporting and importing establishments:

a) Within 10 days from the date of export or import, the establishment must prepare a report on the export or import of narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, using Form No. 02 in Appendix II issued with this Decree, and send it to the Ministry of Public Security and the report-receiving agency specified in Article 124 of this Decree;

b) Before 15 July and before 15 January each year, the establishment must prepare a six-month and annual report on the import and export of combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, combination medicines containing precursors, radioactive medicines, toxic medicines, and medicines on the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields, using Form No. 03 in Appendix II issued with this Decree, and send it to the report-receiving agency specified in Article 124 of this Decree;

c) Before 15 July and before 15 January each year, the establishment prepares a six-month and annual periodic report on the issue, receipt, stock and use of narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, combination medicines containing precursors, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, using Forms No. 04 and 05 in Appendix II issued with this Decree, and sends it to the report-receiving agency specified in Article 124 of this Decree;

d) Before 15 January each year, the establishment must prepare a periodic report on the issue, receipt, stock and use of radioactive medicines, medicinal ingredients that are radioactive substances, toxic medicines, toxic medicinal ingredients, and medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields, using Form No. 04 in Appendix II issued with this Decree, and sends it to the report-receiving agency specified in Article 124 of this Decree.

2. For wholesale establishments, retail establishments, and establishments organising a pharmacy chain:

a) Before 15 July and before 15 January each year, wholesale establishments, retail establishments and establishments organising a pharmacy chain submit a six-month and an annual report, respectively, on the issue, receipt, stock and use of narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors, using Form No. 06 in Appendix II issued with this Decree, and send it to the provincial People's Committee of the locality where the establishment has its head office;

b) Before 15 January each year, wholesale establishments prepare a report on the issue, receipt and stock of radioactive medicines, toxic medicines, toxic medicinal ingredients, and medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields, using Form No. 06 in Appendix II issued with this Decree; retail establishments and establishments organising a pharmacy chain submit an annual report on the issue, receipt and stock of radioactive medicines, using Form No. 06 in Appendix II issued with this Decree, and send it to the provincial People's Committee of the locality where the establishment has its head office.

3. For provincial People's Committees:

a) Before 30 January each year, the provincial People's Committee sends the Ministry of Health a report listing the establishments wholesaling and retailing narcotic medicines, psychotropic medicines, precursor medicines, and combination medicines containing precursors in the province, using Form No. 08 in Appendix II issued with this Decree;

b) Before the 15th day of the first month of each quarter, the provincial People's Committee sends the Ministry of Health a report on the import and export of narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines by establishments in the province, using Form No. 09 in Appendix II issued with this Decree.

4. Where a mix-up or loss of radioactive medicines, narcotic medicines, psychotropic medicines, or precursor medicines, or of medicinal ingredients that are radioactive substances, narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines is discovered, pharmaceutical business establishments prepare a report and send it to the provincial People's Committee of the locality where the establishment has its head office within 48 hours from discovering the mix-up or loss, using Form No. 07 in Appendix II issued with this Decree.

5. Where an establishment trading in or using specially controlled medicines fails to comply with the reporting regime under Clauses 1, 2 and 4 of this Article, receipt and consideration of its dossiers requesting purchase, export or import of medicines and medicinal ingredients will be suspended until the establishment reports in full as prescribed.

Article 36. Provisions on destruction of specially controlled medicines

1. Where there is a need to destroy narcotic medicines, psychotropic medicines, precursor medicines, or medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, the establishment destroys the medicines and medicinal ingredients as follows:

a) At least 07 working days before destroying the medicines and medicinal ingredients, the establishment must send a written notice of the time of destruction, together with the list of medicines and medicinal ingredients to be destroyed, to the competent authority specified in Clause 2 of this Article. The head of the establishment establishes a Council for destruction of medicines and medicinal ingredients. The Council has at least 03 members, including the person in charge of pharmaceutical professional matters of the establishment. The Council for destruction of medicines organises the destruction, decides the method of destruction, and supervises the establishment's destruction of medicines;

b) The destruction of medicines and medicinal ingredients must be witnessed by a representative of the competent authority specified in Clause 2 of this Article and recorded in a record made under Form No. 10 in Appendix II issued with this Decree. The establishment is responsible for destroying the medicines and medicinal ingredients so that there is no loss and no residual active pharmaceutical ingredient in the products after destruction, and for complying with the law on environmental protection when carrying out the destruction;

c) Within 07 working days from the date of finishing the destruction of medicines and medicinal ingredients, the establishment must send the destruction record to the competent authority specified in Clause 2 of this Article.

2. Competence to receive notices of destruction of narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines:

a) The Ministry of National Defence and the Ministry of Public Security, for establishments within their management scope other than pharmaceutical business establishments;

b) The provincial People's Committee of the locality where a pharmaceutical business establishment has its business location, for pharmaceutical business establishments, including those within the management scope of the Ministry of Public Security and the Ministry of National Defence;

c) The provincial People's Committee of the locality where the establishment has its head office, for establishments not falling under the cases specified at Points a and b of this Clause.

3. Radioactive medicines, medicinal ingredients that are radioactive substances, and packaging that has come into direct contact with radioactive medicines or medicinal ingredients that are radioactive substances and is no longer used must be stored, kept and handled in accordance with the law on atomic energy.

4. Waste originating from radioactive medicines and medicinal ingredients that are radioactive substances must be managed under the law on atomic energy.

5. Where there is a need to destroy by-products and waste products containing narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines arising in the production process; combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors; packaging that has come into direct contact with narcotic medicines, psychotropic medicines, precursor medicines, narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines and is no longer used; toxic medicines, toxic medicinal ingredients, and medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields, the establishment does as follows:

a) The establishment must gather the by-products, waste products, medicines, medicinal ingredients and packaging that has come into direct contact with medicines, and store them in a quarantine area as prescribed, and is responsible for security to ensure no loss during storage;

b) The head of the establishment establishes a Council for destruction of medicines of at least 03 members, including the person in charge of pharmaceutical professional matters of the establishment. The Council for destruction of medicines organises the destruction, decides the method of destruction, supervises the establishment's destruction of medicines, and keeps the destruction records at the establishment;

c) The establishment must ensure compliance with the law on environmental protection when carrying out the destruction.

6. For narcotic medicines, psychotropic medicines and precursor medicines in solution form for which the smallest packaging unit to be destroyed has not been fully used, the establishment makes a record of the condition of the medicines at the time of receipt and stores them in a quarantine area as prescribed, and is responsible for security to ensure no loss during storage. When destroying the medicines, the Council for destruction records the actual condition at the time of destruction and carries out the destruction under Clauses 1 and 2 or Clause 5 of this Article.

Article 37. Order and procedures for permitting business in specially controlled medicines

1. An establishment that submits a dossier requesting a Certificate of Eligibility for Pharmaceutical Business under Article 20 of this Decree and also requests permission to trade in specially controlled medicines must additionally submit the following documents:

a) A document explaining how the establishment meets the measures ensuring security and no loss of specially controlled medicines, using Form No. 11 in Appendix II issued with this Decree;

b) The list of medicines and the compounding procedures for medicines, for a retail establishment that is a pharmacy and compounds medicines under prescriptions for specially controlled medicines;

c) The number of dossiers under this Clause is 01 set.

2. Where an establishment already issued a Certificate of Eligibility for Pharmaceutical Business requests permission to trade in specially controlled medicines, it must submit a dossier under Clause 1 of this Article.

3. Order and procedures for permitting business in specially controlled medicines:

a) For the case specified in Clause 1 of this Article, permission is granted under the order and procedures for issuing the Certificate of Eligibility for Pharmaceutical Business specified in Article 21 of this Decree;

b) For the case specified in Clause 2 of this Article, permission is granted under the order and procedures for adjusting the Certificate of Eligibility for Pharmaceutical Business specified in Article 22 of this Decree.

Article 38. Dossier requesting purchase of narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing precursors, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines; dossier requesting transfer of medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines

1. A dossier requesting purchase of narcotic medicines, psychotropic medicines, precursor medicines, and combination medicines containing precursors includes the following documents:

a) 03 original Orders for purchase of narcotic medicines, psychotropic medicines, precursor medicines, and combination medicines containing precursors, using Form No. 12 in Appendix II, together with a medicine receipt-issue-stock report using Form No. 13 in Appendix II issued with this Decree;

b) A document clearly explaining the reasons where the total quantity of medicines requested for purchase plus the quantity in stock exceeds 150% of the total business and use demand in the reporting period; for a pharmaceutical business establishment, documents proving the approved bidding results, or the sale and purchase contract, or the framework contract accompanied by a purchase order clearly stating the name and quantity of medicines. An establishment purchasing medicines for the first time must have an expected business plan for the medicines requested for purchase.

2. A dossier requesting purchase of medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines includes the following documents:

a) 01 original Order for purchase of medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, using Form No. 12 in Appendix II issued with this Decree;

b) A report on the use of medicinal ingredients, using Form No. 05 in Appendix II issued with this Decree;

c) A receipt-issue-stock report on medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, using Form No. 13 in Appendix II issued with this Decree;

d) A plan for using the ingredients requested for purchase;

dd) A document clearly explaining the reasons where the total quantity of medicinal ingredients requested for purchase plus the quantity in stock exceeds 150% of the total business and use demand in the reporting period; for a pharmaceutical business establishment, documents proving the approved bidding results, or the sale and purchase contract, or the framework contract accompanied by a purchase order clearly stating the name and quantity of medicines corresponding to the quantity of ingredients requested for purchase. An establishment purchasing ingredients for the first time must have an expected business plan for the medicines produced from the ingredients requested for purchase.

3. A dossier requesting transfer of medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines includes the following documents:

a) An application by the transferring establishment for transfer of medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, using Form No. 14 in Appendix II issued with this Decree, accompanied by the ingredient-use plan of the receiving establishment;

b) 01 original Order for transfer of medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, using Form No. 12 in Appendix II issued with this Decree;

c) A report on the use of medicinal ingredients, using Form No. 05, and an ingredient receipt-issue-stock report, using Form No. 13 in Appendix II issued with this Decree.

4. The number of dossiers under Clauses 1, 2 and 3 of this Article is 01 set.

Article 39. Order and procedures for permitting the purchase of narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing precursors, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines; and the transfer of medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients and precursors used as medicines

1. The establishment requesting to purchase medicines or medicinal ingredients, or to transfer medicinal ingredients, submits the dossier directly, via postal services, or online to:

a) The Ministry of Health, for dossiers for purchase or transfer of medicinal ingredients by establishments;

b) The Ministry of National Defence, for dossiers for purchase of medicines by establishments under the Ministry of National Defence, except pharmaceutical business establishments;

c) The Ministry of Public Security, for dossiers for purchase of medicines by establishments under the Ministry of Public Security, except pharmaceutical business establishments;

d) The provincial People's Committee of the locality where the establishment has its business location, for dossiers for purchase of medicines by pharmaceutical business establishments, including those within the management scope of the Ministry of Public Security and the Ministry of National Defence;

dd) The provincial People's Committee of the locality where the establishment has its head office, for dossiers for purchase of medicines by establishments not falling under the cases specified at Points b, c and d of this Clause.

2. The agency receiving the dossier gives the requesting establishment a Receipt Slip for the dossier requesting approval of medicine purchase, the dossier requesting approval of purchase of medicinal ingredients, or the dossier requesting transfer of medicinal ingredients, using Form No. 01 in Appendix I issued with this Decree.

3. Where no amendment or supplementation of the dossier is required, the agency receiving the dossier signs to approve the medicine purchase Order, or grants written permission sent to the establishment purchasing or transferring ingredients, within 30 days from the date stated on the Dossier Receipt Slip.

4. Where amendment or supplementation of the purchase or transfer dossier is required, the agency receiving the dossier sends the requesting establishment a document, using Form No. 16 in Appendix I issued with this Decree, within 30 days from the date stated on the Dossier Receipt Slip, which must specifically state the documents and contents to be amended or supplemented.

5. After the establishment submits the amended or supplemented dossier, the agency receiving the dossier gives the establishment a Receipt Slip for the amended or supplemented dossier, using Form No. 01 in Appendix I issued with this Decree.

a) Where the amended or supplemented dossier does not meet the requirements, within 30 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a written reply not approving the Order and clearly stating the reasons, using Form No. 16 in Appendix I issued with this Decree;

b) Where no amendment or supplementation of the amended or supplemented dossier is required, the agency receiving the dossier signs to approve the medicine purchase Order, or grants written permission sent to the establishment purchasing or transferring ingredients, under Clause 3 of this Article.

6. Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation, the requesting establishment must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

Article 40. Order and procedures for permitting business in medicines on the list of restricted-retail medicines

1. For an establishment submitting a dossier requesting a Certificate of Eligibility for Pharmaceutical Business covering the scope of medicine retail that also requests permission to trade in medicines on the list of restricted-retail medicines:

a) The establishment submits the dossier under Article 20 of this Decree, and the application for the Certificate of Eligibility for Pharmaceutical Business includes a request to trade in medicines on the list of restricted-retail medicines;

b) Permission to trade in medicines on the list of restricted-retail medicines is granted under the order and procedures for issuing the Certificate of Eligibility for Pharmaceutical Business specified in Article 21 of this Decree.

2. For an establishment already issued a Certificate of Eligibility for Pharmaceutical Business covering the scope of medicine retail that requests permission to trade in medicines on the list of restricted-retail medicines:

a) The establishment submits 01 original application for adjustment of the Certificate of Eligibility for Pharmaceutical Business, using Form No. 12 in Appendix I issued with this Decree, and the application for adjustment of the Certificate of Eligibility for Pharmaceutical Business includes a request to trade in medicines on the list of restricted-retail medicines;

b) Permission to trade in medicines on the list of restricted-retail medicines is granted under the order and procedures for adjusting the Certificate of Eligibility for Pharmaceutical Business specified in Article 22 of this Decree.

Section 5. PHARMACEUTICAL BUSINESS BY E-COMMERCE

Article 41. Provisions on publishing information when conducting pharmaceutical business by e-commerce

1. A pharmaceutical business establishment conducting business by e-commerce must publish the following information in full:

a) Information on the Certificate of Eligibility for Pharmaceutical Business, including the name of the business establishment, address of the business location, certificate number, date of issue, and issuing agency;

b) Information on the Pharmacy Practising Certificate of the establishment's person in charge of pharmaceutical professional matters, including the full name of the person in charge of professional matters, the number of the Pharmacy Practising Certificate, date of issue, and issuing agency;

c) Information on the medicine, including the medicine name, marketing authorisation number or import licence number; composition, content, concentration or quantity of active pharmaceutical ingredients and medicinal herbs of the medicine; dosage form; packaging specification; shelf life; manufacturing establishment name; country of manufacture; uses or effects, indications, contraindications, dosage, directions for use and matters to note when using the medicine; and actual images of the product.

2. Provisions on publishing information:

a) The information specified at Points a and b, Clause 1 of this Article must be published on the e-commerce sales application, the sales website (also called an e-commerce website), or the store of the pharmaceutical business establishment on the e-commerce trading platform;

b) The medicine information specified at Point c, Clause 1 of this Article must be published in a separate section and must not be mixed with information on other products that are not medicines;

c) The information and images published under Clause 1 of this Article must be displayed fully and clearly, in a prominent and easily readable position;

d) For an establishment organising a pharmacy chain, the contents specified in Clause 1 of this Article must include information on both the establishment organising the pharmacy chain and the pharmacies in the chain participating in e-commerce business;

dd) The pharmaceutical business establishment is responsible for the accuracy and legality of the information and images published.

Article 42. Other provisions when conducting pharmaceutical business by e-commerce

1. An establishment selling medicines and medicinal ingredients is responsible for providing the establishment's Certificate of Eligibility for Pharmaceutical Business and information on the marketing authorisation or import licence of the medicines and medicinal ingredients to the traders and organisations providing e-commerce trading platform services, for checking and supervision before registering to use services on the platform.

2. Information printed on the packaging of goods delivered to customers in the case of retail of medicines by e-commerce must include the customer's name, address and telephone number and the telephone number of the adviser.

3. Information printed on the packaging of goods delivered to customers that are pharmaceutical business establishments wholesaling medicines and medicinal ingredients by e-commerce must include the number and date of issue of the Certificate of Eligibility for Pharmaceutical Business of the establishment wholesaling medicines and medicinal ingredients.

Chapter IV

EXPORT AND IMPORT OF MEDICINES AND MEDICINAL INGREDIENTS

Section 1. EXPORT OF SPECIALLY CONTROLLED MEDICINES AND MEDICINAL HERBS ON THE LIST OF CONTROLLED PRECIOUS, RARE AND ENDEMIC MEDICINAL HERB SPECIES AND VARIETIES

Article 43. Criteria and dossier for requesting an export licence for narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, combination medicines containing precursors, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines

1. Medicines are granted an export licence only when they meet one of the following criteria:

a) Manufactured in Vietnam, having a marketing authorisation in Vietnam, and permitted for import by the competent regulatory authority of the importing country;

b) Manufactured overseas, licensed for circulation in Vietnam, and permitted for import by the competent regulatory authority of the importing country.

2. Medicinal ingredients are granted an export licence only when they meet one of the following criteria:

a) Manufactured in Vietnam, having a marketing authorisation in Vietnam or not yet having a marketing authorisation in Vietnam, and permitted for import by the competent regulatory authority of the importing country;

b) Manufactured overseas, licensed for circulation in Vietnam, and permitted for import by the competent regulatory authority of the importing country.

3. Dossier requesting an export licence:

a) 01 original export Order, using Form No. 01 or 02 in Appendix III issued with this Decree;

b) A report on the quantity and origin of medicines and medicinal ingredients, using Form No. 03 in Appendix III issued with this Decree;

c) The original of a valid import licence for the medicines and medicinal ingredients issued by the competent regulatory authority of the importing country. Where the import licence is not in Vietnamese or English, a translation of the licence into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed. Where the importing country does not require an import licence for medicines and medicinal ingredients upon import, the establishment requesting the export licence provides a document from the competent regulatory authority confirming the host country's regulation that no import licence is required.

The import licence and the confirming document must be consularly legalised under the law on consular legalisation, except where exempted under law.

4. The number of dossiers under this Article is 01 set.

Article 44. Criteria and dossier for requesting an export licence for radioactive medicines and medicinal ingredients that are radioactive substances; medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields; and toxic medicines and toxic medicinal ingredients

1. Medicines and medicinal ingredients are granted an export licence only when they meet one of the following criteria:

a) Manufactured in Vietnam, having a marketing authorisation in Vietnam or not yet having a marketing authorisation in Vietnam;

b) Manufactured overseas and licensed for circulation in Vietnam.

2. Dossier requesting an export licence:

03 original export Orders, using Form No. 04 or 05 in Appendix III issued with this Decree.

3. The number of dossiers under this Article is 01 set.

Article 45. Criteria and dossier for requesting an export licence for medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties

1. Medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties are granted an export licence only when they are not naturally harvested medicinal herbs and are not on the List of medicinal herbs prohibited from export announced by the Minister of Health. Where export is for non-commercial purposes, the law on biodiversity applies.

2. Dossier requesting an export licence:

a) 03 original export Orders, using Form No. 06 in Appendix III issued with this Decree;

b) A copy of the commune-level People's Committee's certification of the origin of the cultivated medicinal herbs, certified or stamped by the exporting establishment. Where the copy is stamped by the establishment, the original must be presented for comparison when submitting the dossier;

c) A certified copy, or a copy stamped by the exporting establishment, of the contract for purchasing the medicinal herbs. Where the copy is stamped by the establishment, the original must be presented for comparison when submitting the dossier;

d) For export for non-commercial purposes, the dossier specified at Points b and c of this Clause is not required.

3. The number of dossiers under this Article is 01 set.

Article 46. Provisions on export licensing of specially controlled medicines for non-commercial purposes

1. Specially controlled medicines exported for non-commercial purposes must be medicines licensed for circulation in Vietnam and fall within one of the following cases:

a) Personal luggage of an organisation or individual departing the country, sent under a bill of lading, or goods carried on the person of an organisation or individual departing the country to treat the departing person's own illness, and not being medicinal ingredients subject to special control;

b) Exported as aid or humanitarian aid;

c) Already licensed for import to serve humanitarian medical examination and treatment activities but not fully used.

2. Medicines must be licensed before export, except where the medicines under Point a, Clause 1 of this Article are in a quantity not exceeding:

a) 07 days of use for narcotic medicines, at the dosage stated in the accompanying prescription;

b) 10 days of use for psychotropic medicines and precursor medicines, at the dosage stated in the accompanying prescription;

c) 30 days of use for combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, combination medicines containing precursors, toxic medicines, and medicines on the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields, at the dosage stated in the accompanying prescription.

3. Dossier requesting an export licence for medicines specified at Point a, Clause 1 of this Article:

a) An application for export of medicines, using Form No. 07 in Appendix III issued with this Decree;

b) A copy of the prescription or outpatient treatment record book, certified, or signed by the applicant, or stamped by the applying organisation. These documents must contain all of the following: the patient's name and age; the medicine name, content or concentration and volume; the quantity of medicines (or number of days of use); the dosage; the full name and signature of the physician; and the address of the hospital or clinic where the physician practises.

Where the copy is signed by the applicant or stamped by the applying organisation, the original must be presented for comparison when submitting the dossier;

c) If the documents specified at Point b of this Clause are not in Vietnamese or English, a translation of them into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed.

4. Dossier requesting an export licence for medicines specified at Point b, Clause 1 of this Article:

a) 03 original Orders, using Form No. 01 or 04 in Appendix III issued with this Decree;

b) The original or a certified copy of the document approving the use of the medicines for aid or humanitarian aid purposes, issued by the competent regulatory authority of the importing country;

c) The original of a valid medicine import licence issued by the competent regulatory authority of the importing country, for narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors;

d) If the documents specified at Points b and c of this Clause are not in Vietnamese or English, a translation into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed. The documents must be consularly legalised under the law on consular legalisation, except where exempted under law.

5. Dossier requesting an export licence for medicines specified at Point c, Clause 1 of this Article:

a) 03 original Orders, using Form No. 01 or 04 in Appendix III issued with this Decree;

b) A report on the quantity of medicines used for humanitarian medical examination and treatment, using Form No. 08 in Appendix III issued with this Decree.

6. The number of dossiers under Clauses 3, 4 and 5 of this Article is 01 set.

Article 47. Criteria and dossier for requesting an export licence for specially controlled medicines for display at exhibitions and fairs

1. Narcotic medicines, psychotropic medicines, precursor medicines, medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors are granted an export licence only when they meet one of the following criteria:

a) Manufactured in Vietnam, having a marketing authorisation in Vietnam or not yet having a marketing authorisation in Vietnam, and having an import licence issued by the competent regulatory authority of the importing country;

b) Manufactured overseas, licensed for circulation in Vietnam, and having an import licence issued by the competent regulatory authority of the importing country.

2. Dossier requesting an export licence for narcotic medicines, psychotropic medicines, precursor medicines, narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursors used as medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors:

a) 01 original export Order, using Form No. 01 or 02 in Appendix III issued with this Decree;

b) The original of a valid import licence for the medicines and medicinal ingredients issued by the competent regulatory authority of the importing country. Where the import licence is not in Vietnamese or English, a translation of the licence into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed. Where the importing country does not require an import licence for medicines and medicinal ingredients upon import, the establishment requesting the export licence provides a document from the competent regulatory authority confirming the host country's regulation that no import licence is required.

The import licence and the confirming document must be consularly legalised under the law on consular legalisation, except where exempted under law;

c) The number of dossiers under this Clause is 01 set.

3. The export of radioactive medicines, medicinal ingredients that are radioactive substances; toxic medicines, toxic medicinal ingredients; and medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields for display at exhibitions and fairs is carried out under the law on temporary export and re-import of goods.

Article 48. Criteria and dossier for requesting an export licence for specially controlled medicines for the purposes of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, scientific research, and registration samples

1. Narcotic medicines, psychotropic medicines, precursor medicines, medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors are granted an export licence only when they meet one of the following criteria:

a) Manufactured in Vietnam, having a marketing authorisation in Vietnam or not yet having a marketing authorisation in Vietnam, and having an import licence issued by the competent regulatory authority of the importing country;

b) Manufactured overseas, already licensed for circulation in Vietnam, and having an import licence issued by the competent regulatory authority of the importing country.

2. Dossier requesting an export licence for narcotic medicines, psychotropic medicines, precursor medicines, medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors:

a) 01 original export Order, using Form No. 01 or 02 in Appendix III issued with this Decree;

b) The original of a valid import licence for the medicines and medicinal ingredients issued by the competent regulatory authority of the importing country. Where the import licence is not in Vietnamese or English, a translation of the licence into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed. Where the importing country does not require an import licence for medicines and medicinal ingredients upon import, the establishment requesting the export licence provides a document from the competent regulatory authority confirming the host country's regulation that no import licence is required.

The import licence and the confirming document must be consularly legalised under the law on consular legalisation, except where exempted under law;

c) The number of dossiers under this Clause is 01 set.

3. Radioactive medicines, medicinal ingredients that are radioactive substances; toxic medicines, toxic medicinal ingredients; and medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields are granted an export licence only when they meet one of the following criteria:

a) Manufactured in Vietnam, having a marketing authorisation in Vietnam or not yet having a marketing authorisation in Vietnam;

b) Manufactured overseas and licensed for circulation in Vietnam.

4. Dossier requesting an export licence for radioactive medicines, medicinal ingredients that are radioactive substances; toxic medicines, toxic medicinal ingredients; and medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields: 01 original export Order, using Form No. 04 or 05 in Appendix III issued with this Decree.

Article 49. Procedures and time limits for issuing export licences for specially controlled medicines and medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties

1. Procedures and time limits for issuing export licences for specially controlled medicines and medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties specified in Articles 43, 44 and 45, Points b and c, Clause 1, Article 46, Clause 1, Article 47, and Article 48 of this Decree:

a) The establishment requesting an export licence submits the dossier directly, via postal services, or online to the Ministry of Health or the provincial People's Committee of the locality where the establishment has its head office, under the roadmap specified in Article 123 of this Decree.

Where the establishment submits the dossier specified in Articles 43, 46, 47 and 48 of this Decree online, the original of the import licence for the medicines and medicinal ingredients must be submitted separately via postal services or directly to the competent authority.

b) After receiving the dossier, the agency receiving the dossier gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, the agency receiving the dossier issues the export licence within 07 working days from the date stated on the Dossier Receipt Slip;

d) Where amendment or supplementation of the dossier is required, the agency receiving the dossier issues a written reply, using Form No. 16 in Appendix I issued with this Decree, requesting amendment or supplementation of the dossier within 07 working days from the date stated on the Dossier Receipt Slip;

dd) After receiving the amended or supplemented dossier, the agency receiving the dossier gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, the agency receiving the dossier issues a written reply clearly stating the reasons for not issuing the export licence, using Form No. 16 in Appendix I issued with this Decree, within 07 working days from the date stated on the Dossier Receipt Slip. Where no amendment or supplementation of the amended or supplemented dossier is required, the agency receiving the dossier issues the export licence under Point c of this Clause;

e) Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation, the establishment requesting the export licence must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

2. Procedures and time limits for issuing export licences for medicines specified at Point a, Clause 1, Article 46 of this Decree:

a) The organisation or individual requesting the export licence submits the dossier directly, via postal services, or online to the provincial People's Committee of the locality of the border gate where exit procedures are carried out, or where the patient resides or temporarily resides lawfully, or where the organisation has its head office;

b) After receiving the dossier, the provincial People's Committee gives the requesting organisation or individual a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, the provincial People's Committee issues the export licence within 07 working days from the date stated on the Dossier Receipt Slip;

d) Where amendment or supplementation of the dossier is required, the provincial People's Committee issues a written reply, using Form No. 16 in Appendix I issued with this Decree, requesting amendment or supplementation of the dossier within 05 working days from the date stated on the Dossier Receipt Slip;

dd) After receiving the amended or supplemented dossier, the provincial People's Committee gives the organisation or individual a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, the provincial People's Committee issues a written reply clearly stating the reasons for not issuing the export licence, using Form No. 16 in Appendix I issued with this Decree, within 05 working days from the date stated on the Dossier Receipt Slip. Where no amendment or supplementation of the amended or supplemented dossier is required, the provincial People's Committee issues the export licence under Point c of this Clause;

e) Within 03 months from the date the provincial People's Committee issues the written notice of amendment or supplementation, the organisation or individual requesting the export licence must submit the amended or supplemented dossier as required. After that period, if the organisation or individual has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

3. Within 03 working days from the date of issuing the licence, the licensing agency is responsible for publishing, on its web portal, information on medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties that have been licensed for export.

4. The export licence templates are prescribed in Forms No. 09, 10, 11, 12 and 13 in Appendix III issued with this Decree.

Article 50. Management of export of medicines and medicinal ingredients

1. An export licence for narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, combination medicines containing precursors, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines is issued for each export; the quantity of medicines and medicinal ingredients licensed for export must not exceed the quantity stated in the import licence issued by the competent regulatory authority of the importing country. Where the host country confirms that importing the medicines and medicinal ingredients does not require a licence, the quantity licensed for export is according to the needs of the exporting establishment.

2. An export licence for medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties is issued for each export.

3. Narcotic medicines, psychotropic medicines, precursor medicines, radioactive medicines, medicinal ingredients that are radioactive substances, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, combination medicines containing precursors, medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, and medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties may be exported only through international border gates, except medicines specified at Point a, Clause 1, Article 46 of this Decree.

4. An establishment producing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines may export the medicines and medicinal ingredients it produces itself.

5. An establishment exporting or importing narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines may export the medicines and medicinal ingredients it trades in itself.

6. An individual or organisation requesting export of specially controlled medicines for non-commercial purposes under Point a, Clause 1, Article 46 of this Decree is responsible for the origin, quality, safety and efficacy of the exported medicines and for meeting the regulations of the importing country.

7. The exporting establishment is responsible for re-importing all narcotic medicines, psychotropic medicines, precursor medicines, medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, and combination medicines containing precursors that were temporarily exported for display at exhibitions and fairs.

Section 2. IMPORT OF MEDICINES WITHOUT A MARKETING AUTHORISATION IN VIETNAM

Article 51. Criteria and dossier for requesting an import licence for medicines containing active pharmaceutical ingredients without a marketing authorisation, and medicines containing medicinal herbs used for the first time in Vietnam

1. Medicines are granted an import licence when they meet the following criteria:

a) Licensed for circulation in one of the following countries: the country of manufacture, a member country of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), or Australia;

b) The medicine falls within one of the following cases:

It is included in guidelines on diagnosis, prevention and treatment of diseases issued or approved by the Ministry of Health;

It is a medicine used for emergency, antidote or anti-transplant-rejection purposes;

It is a medicine used for diagnosis, prevention or treatment of group A infectious diseases; cancer; HIV/AIDS; viral hepatitis; tuberculosis; malaria; and other diseases decided by the Minister of Health.

2. Dossier requesting an import licence:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) The original, a certified copy, or a copy accompanied by the original for comparison, of the Certificate of Pharmaceutical Product;

c) A copy of the manufacturer's quality standards and testing methods for the medicine, stamped by the importing establishment;

d) 01 set of samples of the medicine label and package leaflet in actual circulation in the country of manufacture or export, bearing the confirmation stamp of the manufacturer, the product owner or the product licence holder (stated on the Certificate of Pharmaceutical Product) and of the importing establishment (colour prints matching the label in circulation in the host country are accepted);

dd) 02 sets of samples of the label expected to be circulated in Vietnam, with a Vietnamese package leaflet, stamped by the importing establishment;

e) Clinical safety and efficacy data in accordance with the Minister of Health's regulation on drug registration, which must include phase 3 clinical data.

The documents under this point need not be submitted where the medicine has previously been licensed for import under this Article and there is no change in information on indications, dosage, or target users;

g) A report on the results of trading the medicines, where the imported medicines are narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, or combination medicines containing precursors, using Form No. 18 in Appendix III issued with this Decree;

h) The original, a certified copy, or a copy accompanied by the original for comparison, of the Good Manufacturing Practice certificate or manufacturing licence of all establishments participating in the manufacture of the imported medicine. Where the competent regulatory authority does not issue a Good Manufacturing Practice certificate or manufacturing licence, the importing establishment submits the original, a certified copy, or a copy accompanied by the original for comparison, of the most recent Good Manufacturing Practice inspection report of all establishments participating in the manufacture of the imported medicine.

The documents under this point need not be submitted where the manufacturing establishment has been confirmed on the Certificate of Pharmaceutical Product as meeting the principles and standards of Good Manufacturing Practice.

3. The number of dossiers under this Article is 01 set.

Article 52. Criteria and dossier for requesting an import licence for medicines containing active pharmaceutical ingredients that have a marketing authorisation in Vietnam but do not fully meet treatment needs, and medicines containing medicinal herbs previously used as medicines in Vietnam but that do not fully meet treatment needs

1. Medicines are granted an import licence when they meet the following criteria:

a) Being on the List of medicines not fully meeting treatment needs announced by the Minister of Health;

b) Licensed for circulation in one of the following countries: the country of manufacture, an ICH member country, or Australia.

2. Dossier requesting an import licence:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) The original, a certified copy, or a copy accompanied by the original for comparison, of the Certificate of Pharmaceutical Product;

c) A quality dossier under the Minister of Health's regulation on applying the ASEAN Common Technical Dossier (ACTD) or the ICH Common Technical Document (ICH-CTD) in drug registration, or quality standards and bioequivalence study results under Clause 6, Article 61 of this Decree;

d) 01 set of samples of the medicine label and package leaflet in actual circulation in the country of manufacture or export, bearing the confirmation stamp of the manufacturer, the product owner or the product licence holder (stated on the Certificate of Pharmaceutical Product) and of the importing establishment (colour prints matching the label in circulation in the host country are accepted);

dd) 02 sets of samples of the label expected to be circulated in Vietnam, with a Vietnamese package leaflet, stamped by the importing establishment;

e) A clinical dossier for medicines required to submit a clinical dossier under the Minister of Health's regulation on drug registration.

The documents under this point need not be submitted where the medicine has previously been licensed for import under this Article and there is no change in information on indications, dosage, or target users;

g) For traditional medicines with a new combination of medicinal herbs previously used as medicines in Vietnam, a full clinical dossier proving safety and efficacy as prescribed in Article 89 of the Law on Pharmacy, and documents proving the processing, compounding or formulation method in accordance with traditional medicine theory;

h) A report on the results of trading the medicines, where the imported medicines are narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, or combination medicines containing precursors, using Form No. 18 in Appendix III issued with this Decree;

i) The original, a certified copy, or a copy accompanied by the original for comparison, of the Good Manufacturing Practice certificate or manufacturing licence of all establishments participating in the manufacture of the imported medicine. Where the competent regulatory authority does not issue a Good Manufacturing Practice certificate or manufacturing licence, the importing establishment submits the original, a certified copy, or a copy accompanied by the original for comparison, of the most recent Good Manufacturing Practice inspection report of all establishments participating in the manufacture of the imported medicine.

The documents under this point need not be submitted where the manufacturing establishment has been confirmed on the Certificate of Pharmaceutical Product as meeting the principles and standards of Good Manufacturing Practice.

3. The number of dossiers under this Article is 01 set.

Article 53. Criteria and dossier for requesting an import licence for medicines meeting urgent needs for national defence and security, epidemic prevention and control, and remedying the consequences of natural disasters and catastrophes

1. Medicines are granted an import licence when they simultaneously meet the following criteria:

a) Already licensed for circulation in at least one country in the world;

b) Meeting urgent needs for national defence and security, epidemic prevention and control, and remedying the consequences of natural disasters and catastrophes.

2. Dossier requesting an import licence for medicines meeting urgent needs for national defence and security:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) The original, a certified copy, or a copy accompanied by the original for comparison, of the Certificate of Pharmaceutical Product, or confirmation from the competent regulatory authority of the exporting country that the medicine is in circulation in at least 01 country in the world;

c) The original, or a copy stamped by the competent authority, of the document requesting import of medicines meeting urgent needs for national defence from the Ministry of National Defence, or the document requesting import of medicines meeting urgent needs for security from the Ministry of Public Security. The request document must state: the active ingredient for chemical medicines and biologicals, or the name of the medicinal herb for herbal medicines and traditional medicines; the dosage form; the concentration or content of the active pharmaceutical ingredient for chemical medicines and biologicals, or the quantity of medicinal herb for herbal medicines and traditional medicines; the packaging specification; and the manufacturer and country of manufacture of the medicine.

3. Dossier requesting an import licence for medicines meeting urgent needs for epidemic prevention and control and remedying the consequences of natural disasters and catastrophes, except the case specified in Clause 4 of this Article:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) The original, a certified copy, or a copy accompanied by the original for comparison, of the Certificate of Pharmaceutical Product, or confirmation from the competent regulatory authority of the exporting country that the medicine is in circulation in at least 01 country in the world;

c) The original of the Letter of Authorisation from the manufacturer or the marketing authorisation holder stated on the Certificate of Pharmaceutical Product to the establishment requesting import of the medicines into Vietnam, where the importing establishment is not the manufacturer or the marketing authorisation holder of the medicine in the country of manufacture or export;

d) 01 set of samples of the medicine label and package leaflet in actual circulation in the country of manufacture or export, bearing the confirmation stamp of the manufacturer, the product owner or the product licence holder (stated on the Certificate of Pharmaceutical Product) and of the importing establishment (colour prints matching the label in circulation in the host country are accepted);

dd) Quality dossier;

e) Clinical dossier;

g) The original, a certified copy, or a copy accompanied by the original for comparison, of the Good Manufacturing Practice certificate or manufacturing licence of all establishments participating in the manufacture of the imported medicine. Where the competent regulatory authority does not issue a Good Manufacturing Practice certificate or manufacturing licence, the importing establishment submits the original, a certified copy, or a copy accompanied by the original for comparison, of the most recent Good Manufacturing Practice inspection report of all establishments participating in the manufacture of the imported medicine.

The document need not be submitted where the medicine manufacturing establishment has been confirmed on the Certificate of Pharmaceutical Product as meeting the principles and standards of Good Manufacturing Practice.

4. Dossier requesting an import licence for medicines meeting urgent needs for epidemic prevention and control and remedying the consequences of natural disasters and catastrophes for which the Minister of Health has issued a written approval of the urgent need for epidemic prevention and control and remedying the consequences of natural disasters and catastrophes:

a) The dossiers specified at Points a and b, Clause 3 of this Article;

b) The original or a copy of the Ministry of Health's written approval of the urgent need for epidemic prevention and control and remedying the consequences of natural disasters and catastrophes, which must state: the active ingredient for chemical medicines and biologicals, or the name of the medicinal herb for herbal medicines and traditional medicines; the dosage form; the concentration or content of the active pharmaceutical ingredient for chemical medicines and biologicals, or the quantity of medicinal herb for herbal medicines and traditional medicines; the packaging specification; and the manufacturer and country of manufacture of the medicine.

5. The number of dossiers under this Article is 01 set.

Article 54. Criteria and dossier for requesting an import licence for medicines meeting special treatment needs

1. Medicines (except vaccines) are granted an import licence when they meet the following criterion:

The medicine (except vaccines) is necessary to meet special treatment needs where there is no medicine with the same active ingredient, concentration, content and dosage form granted a marketing authorisation in Vietnam, or there is a medicine granted a marketing authorisation in Vietnam but not supplied sufficiently for treatment needs, or there is a medicine granted a marketing authorisation in Vietnam but with a treatment difference from it, in one of the following cases:

a) It is used for emergency, antidote or anti-transplant-rejection purposes, or is on the List of rare medicines;

b) It is included in guidelines on prevention and management of anaphylactic shock issued or approved by the Ministry of Health;

c) It is used for a specific patient being treated at a medical examination and treatment establishment for diagnosis, prevention or treatment of group A infectious diseases; cancer; HIV/AIDS; tuberculosis; malaria; and other life-threatening diseases decided by the Minister of Health;

d) It is used to treat diseases on the List of rare diseases issued by the Minister of Health.

2. Vaccines are granted an import licence when they meet the following criterion: The vaccine is necessary to serve the vaccination needs of people travelling to countries and territories with diseases not present in Vietnam and for which no vaccine of the same type has been granted a marketing authorisation in Vietnam.

3. Dossier requesting an import licence:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) Documents proving the quality, safety and efficacy of the vaccine requested for import, for the case specified in Clause 2 of this Article.

The documents under this point need not be submitted where the vaccine has been prequalified by the World Health Organization.

The documents proving safety and efficacy need not be submitted where the vaccine is on the list of rare medicines;

c) The original of a document from the medical examination and treatment establishment clearly stating the reasons for requesting import of the medicine, the expected number of patients needing the medicine, the corresponding medicine demand, and a commitment to take full responsibility for the use of the medicine requested for import; the original of a document from the vaccination establishment clearly stating the reasons for requesting import of the vaccine, the expected number of people needing the vaccine, the corresponding vaccine demand, and a commitment to take full responsibility for the use of the vaccine requested for import. The document must be accompanied by the original, or a copy stamped by the medical examination and treatment establishment, of the minutes of the Drug and Therapeutics Council meeting on the demand for imported medicines. Where the vaccination establishment has no Drug and Therapeutics Council, or where the medicine is used for emergency or antidote purposes and the document of the medical examination and treatment establishment clearly lists the patients needing the medicine, the minutes need not be submitted;

d) The list of medicines requested for import by the medical examination and treatment establishment or vaccination establishment, using Form No. 19, 20 or 21 in Appendix III issued with this Decree;

dd) A report by the medical examination and treatment establishment or vaccination establishment on the medicines requested for import, using Form No. 22 in Appendix III issued with this Decree;

e) The original of the Undertaking of the foreign manufacturer and medicine supplier on ensuring the quality, safety and efficacy of the vaccines supplied to Vietnam, using Form No. 23 in Appendix III issued with this Decree;

g) The medicine supplier is not required to comply with Article 78 of this Decree if there is a certified and consularly legalised copy of the Pharmaceutical Business Licence issued by the competent authority of the host country as prescribed.

4. The number of dossiers under Clause 3 of this Article is 01 set.

Article 55. Criteria and dossier for requesting an import licence for rare medicines

1. Medicines are granted an import licence when they meet the following criteria:

a) Being on the List of rare medicines;

b) Already licensed for circulation in at least one country in the world.

2. Dossier requesting an import licence:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) The original, a certified copy, or a copy accompanied by the original for comparison, of the Certificate of Pharmaceutical Product;

c) A copy of the manufacturer's quality standards and testing methods for the medicine, stamped by the importing establishment;

d) 01 set of samples of the medicine label and package leaflet in actual circulation in the country of manufacture or export, bearing the confirmation stamp of the manufacturer, the product owner or the product licence holder (stated on the Certificate of Pharmaceutical Product) and of the importing establishment (colour prints matching the label in circulation in the host country are accepted);

dd) 02 sets of samples of the label expected to be circulated in Vietnam, with a Vietnamese package leaflet, stamped by the importing establishment;

e) A report on the results of trading the medicines, where the imported medicines are narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, or combination medicines containing precursors, using Form No. 18 in Appendix III issued with this Decree;

g) The original, a certified copy, or a copy accompanied by the original for comparison, of the Good Manufacturing Practice certificate or manufacturing licence of all establishments participating in the manufacture of the imported medicine. Where the competent regulatory authority does not issue a Good Manufacturing Practice certificate or manufacturing licence, the importing establishment submits the original, a certified copy, or a copy accompanied by the original for comparison, of the most recent Good Manufacturing Practice inspection report of all establishments participating in the manufacture of the imported medicine.

The documents under this point need not be submitted where the manufacturing establishment has been confirmed on the Certificate of Pharmaceutical Product as meeting the principles and standards of Good Manufacturing Practice.

3. The number of dossiers under this Article is 01 set.

Article 56. Criteria and dossier for requesting an import licence for medicines with the same trade name, active ingredient, content or concentration, and dosage form as a reference brand-name medicine that has a marketing authorisation in Vietnam, manufactured by the reference brand-name manufacturer itself or by an authorised manufacturer, and priced lower than the reference brand-name medicine in circulation in Vietnam

1. Medicines may be imported only when they meet the following criteria:

a) Meeting Point dd, Clause 2, Article 60 of the Law on Pharmacy;

b) Having an expected wholesale price at least 20% lower than the winning bid price of the reference brand-name medicine having a marketing authorisation in Vietnam;

c) Licensed for circulation and for export to Vietnam from the country of manufacture, an ICH member country, or Australia;

d) Not being a radioactive medicine, vaccine or biological.

2. Dossier requesting an import licence:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) Documents proving that the medicine is lawfully in circulation in the country of manufacture or the reference country;

c) 01 set of samples of the medicine label and package leaflet in actual circulation in the country of manufacture or export, bearing the confirmation stamp of the manufacturer, the product owner or the product licence holder (stated on the Certificate of Pharmaceutical Product) and of the importing establishment (colour prints matching the label in circulation in the host country are accepted);

d) 02 sets of supplementary labels with a Vietnamese package leaflet, stamped by the importing establishment. The content of the Vietnamese package leaflet must be consistent with the content approved by the Ministry of Health for the reference brand-name medicine having a marketing authorisation in Vietnam.

3. The number of dossiers under this Article is 01 set.

Article 57. Criteria and dossier for requesting an import licence for aid and humanitarian aid medicines

1. Medicines are granted an import licence when they meet the following criterion:

The medicine is licensed for circulation in the country of manufacture, an ICH member country, or Australia and falls within one of the following cases:

a) Medicines provided as aid, brought by foreign humanitarian medical examination and treatment missions to serve humanitarian medical examination and treatment;

b) Medicines provided as aid for a specific patient being treated at a medical examination and treatment establishment at the request of that establishment;

c) Medicines provided as aid for use in State health programmes or State health projects;

d) Aid medicines not falling within the cases specified at Points a, b and c of this Clause and not being narcotic medicines, radioactive medicines or vaccines.

2. Dossier requesting an import licence:

a) 03 original import Orders, using Form No. 24, 25 or 26 in Appendix III issued with this Decree;

b) The original of a document from the establishment receiving the aid or humanitarian aid, clearly stating the quantity of each type of medicine received as aid or humanitarian aid and a commitment to use the medicines for the proper purpose and proper beneficiaries;

c) The original or a certified copy of the document of the competent State management agency approving receipt of the aid or humanitarian aid, or the original of the competent authority's approval of conducting humanitarian medical examination and treatment activities together with the list of aid medicines, for imports under Point a, Clause 1 of this Article;

d) The original, a certified copy, or a copy accompanied by the original for comparison, of the Certificate of Pharmaceutical Product;

dd) A quality dossier under the Minister of Health's regulation on applying the ASEAN Common Technical Dossier (ACTD) or the ICH Common Technical Document (ICH-CTD) in drug registration, or quality standards and bioequivalence study results under Clause 6, Article 61 of this Decree;

e) A clinical dossier for cases required to submit a clinical dossier under the Minister of Health's regulation on drug registration.

The documents under this point need not be submitted where the medicine has previously been licensed for import under this Article and there is no change in information on indications, dosage, or target users;

g) 01 set of samples of the medicine label and package leaflet in actual circulation in the country of manufacture or export, bearing the confirmation stamp of the manufacturer, the product owner or the product licence holder (stated on the Certificate of Pharmaceutical Product) and of the importing establishment (colour prints matching the label in circulation in the host country are accepted);

h) 02 sets of samples of the label expected to be circulated in Vietnam and a Vietnamese package leaflet, stamped by the importing establishment;

i) The original, a certified copy, or a copy accompanied by the original for comparison, of the Good Manufacturing Practice certificate or manufacturing licence of all establishments participating in the manufacture of the imported medicine. Where the competent regulatory authority does not issue a Good Manufacturing Practice certificate or manufacturing licence, the importing establishment submits the original, a certified copy, or a copy accompanied by the original for comparison, of the most recent Good Manufacturing Practice inspection report of all establishments participating in the manufacture of the imported medicine.

The documents under this point need not be submitted where the manufacturing establishment has been confirmed on the Certificate of Pharmaceutical Product as meeting the principles and standards of Good Manufacturing Practice;

k) The documents specified at Points d, dd, e, g, h and i of this Clause are exempted for imports of medicines specified at Points a and b, Clause 1 of this Article, but there must be a written undertaking from the establishment receiving the aid that the medicines are licensed for circulation in the country of manufacture, an ICH member country, or Australia, and, for the case specified at Point b, Clause 1 of this Article, the document of the establishment receiving the aid must clearly list the patients needing the medicines.

3. The number of dossiers under this Article is 01 set.

Article 58. Criteria and dossier for requesting an import licence for medicines used for clinical trials, bioequivalence testing, bioavailability assessment, testing samples, and scientific research

1. Medicines are granted an import licence when they fall within one of the following cases:

a) Specially controlled medicines used in clinical trial research, with the clinical trial research outline approved by the Minister of Health under Clause 1, Article 94 of the Law on Pharmacy and with full information on the medicine requested for import, including: medicine name, active ingredient name, content, dosage form, packaging specification, quantity, shelf life, quality standards, indications, manufacturer name, and country of manufacture;

b) Used as test medicines in bioequivalence testing and bioavailability assessment in Vietnam under an outline approved under Clause 1, Article 100 of the Law on Pharmacy;

c) Used as reference medicines in bioequivalence testing. Where the reference medicine is a new medicine, it is used only in research under an outline approved under Clause 1, Article 100 of the Law on Pharmacy;

d) Used in testing and verification at medicine manufacturing establishments or at medicine testing and verification establishments;

dd) Used in scientific research not falling within the cases specified at Points a, b and c of this Clause.

2. Dossier requesting an import licence:

a) 03 original import Orders, using Form No. 15, 16 or 17 in Appendix III issued with this Decree;

b) The original, a certified copy, or a copy accompanied by the original for comparison, of the approval document of the corresponding competent agency or organisation, for medicines under Points a, b and dd, Clause 1 of this Article;

c) The original, a certified copy, or a copy accompanied by the original for comparison, of the document approving the bioequivalence testing outline under Article 100 of the Law on Pharmacy, for new medicines under Point c, Clause 1 of this Article;

d) An explanatory document stamped by the importing establishment on the purpose and quantity of import and a commitment to use the medicines for the proper purpose.

3. The number of dossiers under this Article is 01 set.

Article 59. Criteria and dossier for requesting an import licence for medicines for display at exhibitions and fairs

1. Medicines are granted an import licence when they simultaneously meet the following criteria:

a) Used only for display at exhibitions and fairs related to medicine, pharmacy and medical equipment;

b) Not being narcotic medicines, psychotropic medicines, precursor medicines or radioactive medicines.

2. Dossier requesting an import licence: 03 original import Orders, using Forms No. 15, 16 and 17 in Appendix III issued with this Decree.

3. The number of dossiers under this Article is 01 set.

4. Medicines under this Article must comply with the law on temporary import and re-export of goods.

Article 60. Criteria and dossier for requesting an import licence for medicines for non-commercial purposes under Point i, Clause 2, Article 60 of the Law on Pharmacy, except medicines imported by a medical examination and treatment establishment to serve special treatment of the establishment's patients

1. Medicines are imported on a non-commercial basis when they fall within one of the following cases:

a) Personal luggage of a person entering the country, sent under a bill of lading, or goods carried on the person of a person entering the country to treat that person's own illness;

b) Not being narcotic medicines, psychotropic medicines or precursor medicines, and being goods of diplomatic missions, consular offices and representative offices of international organisations in Vietnam or Vietnamese diplomatic missions abroad, persons working at these agencies and organisations, or organisations introduced by Vietnamese diplomatic missions or Vietnamese diplomatic missions abroad.

2. The medicines specified in Clause 1 of this Article may be imported without an import licence when they fall within one of the following cases:

a) The imported quantity does not exceed the quantity for use of at most 07 days for narcotic medicines or 10 days for psychotropic medicines and precursor medicines, at the dosage stated in the accompanying prescription;

b) The imported medicines are not narcotic medicines, psychotropic medicines or precursor medicines, with a total customs value of not more than USD 200 (two hundred United States dollars) (calculated at the tax-calculation exchange rate under the law on customs at the time of customs clearance) per consignment, and the number of times of receiving medicines is not more than 03 times a year for each organisation or individual.

Where the medicines are used for a person suffering from a disease on the List of life-threatening diseases specified in Decree No. 134/2016/ND-CP dated 01 September 2016 of the Government detailing a number of articles and measures for implementing the Law on Export Duty and Import Duty, the medicines with a total customs value of not more than VND 10,000,000 (ten million) per consignment, and the number of times of receiving medicines is not more than 04 times a year for each individual;

c) The imported medicines are not narcotic medicines, psychotropic medicines or precursor medicines, and the imported quantity does not exceed the quantity for use of at most 30 days at the dosage stated in the prescription.

3. Dossier requesting an import licence:

a) An application for import of medicines, using Form No. 27 in Appendix III issued with this Decree;

b) A certified copy, or a copy signed by the person requesting the import licence, of the prescription or outpatient treatment record book. These documents must contain all of the following: the patient's name and age; the medicine name, content or concentration and volume; the quantity of medicines (or number of days of use); the dosage; the full name and signature of the physician; and the address of the hospital or clinic where the physician practises.

Where a copy signed by the person requesting the import licence is submitted, the original must be presented for comparison when submitting the dossier.

For medicines specified at Point b, Clause 1 of this Article, the documents specified under this point need not be submitted.

4. The number of dossiers under this Article is 01 set.

Article 61. Specific provisions on documents in dossiers requesting import licences for medicines

1. For medicines imported under Articles 51, 52 and 55 of this Decree, a separate Order must be prepared for each imported medicine, except where the medicines share all of the following elements:

a) Medicine name;

b) Dosage form and route of administration;

c) Concentration or content of the active pharmaceutical ingredient, for liquid and semi-solid medicines;

d) Medicine quality standards;

dd) Shelf life of the medicine;

e) Name and address of the medicine manufacturer.

2. If documents in the dossier are not in Vietnamese or English, the dossier must additionally include a translation of them into Vietnamese or English, with the translator's signature certified as prescribed.

3. The following documents must be consularly legalised under the law on consular legalisation, except where exempted under law:

a) The Certificate of Pharmaceutical Product;

b) The Good Manufacturing Practice certificate for medicines, or the manufacturing licence, or the Good Manufacturing Practice inspection report.

4. Requirements for the Certificate of Pharmaceutical Product, except for imported medicines meeting urgent needs for national defence and security, epidemic prevention and control, and remedying the consequences of natural disasters and catastrophes under Article 53 of this Decree:

a) It must comply with Clauses 2, 3 and 5 of this Article;

b) It must bear the signature, name and title of the signatory, the date of issue, and the seal of the competent State agency of the host country that issues the Certificate of Pharmaceutical Product;

c) The signature, name and title of the signatory and the seal of the competent State agency of the host country that issues the Certificate of Pharmaceutical Product must be fully authenticated by a diplomatic mission, consular office or other agency authorised to perform consular functions of the host country, except where the Certificate of Pharmaceutical Product is an electronic copy without the signature, signatory's name, or confirmation seal of the competent agency issuing the Certificate of Pharmaceutical Product;

d) The Certificate of Pharmaceutical Product used for the consular legalisation procedure must be the original;

dd) It must confirm that the medicine is licensed for circulation in the country issuing the Certificate of Pharmaceutical Product;

e) Where a medicine is manufactured with the participation of multiple manufacturing establishments, the Certificate must clearly state the name, address and role of each establishment;

g) It must contain all the contents under the template of the World Health Organization (WHO) applicable to the Certification Scheme on the quality of pharmaceutical products moving in international commerce;

h) A Certificate of Pharmaceutical Product that is an electronic copy published on the English-language website or database of the issuing competent authority or of competent authorities of countries, or on an English-language website or database operated by a regional pharmaceutical regulatory authority, is accepted, including an electronic copy without the signature, signatory's name, or confirmation seal of the competent agency issuing the Certificate of Pharmaceutical Product.

Where the Certificate of Pharmaceutical Product is issued as an electronic copy, the importing establishment must submit the original or a certified copy of the Certificate of Pharmaceutical Product authenticated by the foreign competent authority and consularly legalised as prescribed, or the result of its own lookup of the Certificate of Pharmaceutical Product, stamped by the importing establishment, accompanied by a document providing the lookup link to the Ministry of Health.

Where the legal document cannot be looked up, the importing establishment submits, together with it, a document providing the official contact information (telephone number, email) of the issuing agency so that the Ministry of Health can directly communicate with it to verify the authenticity of the Certificate of Pharmaceutical Product.

5. Documents in the dossier that state a validity period must still be valid at the time of receipt stated on the Dossier Receipt Slip.

6. Provisions on quality standards, testing methods and bioequivalence study results:

a) They must be copies stamped by the manufacturer, the product owner or the product licence holder (stated on the Certificate of Pharmaceutical Product) and by the importing establishment;

b) Bioequivalence study results are required only in cases where bioequivalence study data must be reported under the Minister of Health's regulation on drug registration.

The documents under this point need not be submitted where the medicine is manufactured and licensed for circulation (as shown on the Certificate of Pharmaceutical Product) in a permanent or founding member country of ICH, or in Australia.

Article 62. Competence, procedures and time limits for issuing import licences for medicines without a marketing authorisation in Vietnam

1. Competence to issue import licences for medicines without a marketing authorisation in Vietnam:

a) The Ministry of Health issues import licences for medicines for imports under Articles 51, 52, 53, 54, 55 and 56 of this Decree, except where otherwise provided by law;

b) The Ministry of Health, or the provincial People's Committee of the locality where the establishment has its head office under the roadmap specified in Article 123 of this Decree, issues import licences for medicines for imports under Articles 57, 58 and 59 of this Decree;

c) The provincial People's Committee of the locality of the border gate where entry procedures are carried out, or where the patient resides or temporarily resides lawfully, or where the organisation has its head office, issues import licences for medicines for imports under Article 60 of this Decree;

d) The Ministry of Health or the provincial People's Committee exercising the competence to issue medicine import licences establishes a council with the function of advising on the issuance of medicine import licences, to advise on issuing medicine import licences under Articles 51 and 52, Clause 3, Article 53, Article 55, and Points c and d, Clause 1, Article 57 of this Decree.

2. Procedures and time limits for issuing import licences for medicines under Articles 51, 52 and 55 and Points c and d, Clause 1, Article 57 of this Decree:

a) The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health, for import licensing of medicines under Articles 51, 52 and 55 of this Decree.

The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health or the provincial People's Committee of the locality where the establishment has its head office under the roadmap specified in Article 123 of this Decree, for import of medicines specified at Points c and d, Clause 1, Article 57 of this Decree;

b) After receiving the dossier, the agency receiving the dossier gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) For dossiers requesting import licences under Articles 51, 52 and 55 of this Decree, where no amendment or supplementation of the dossier is required, from the date stated on the Dossier Receipt Slip, within 60 days for dossiers not requiring clinical data or documents proving similarity to the reference biological, or 90 days for dossiers requiring clinical data or documents proving similarity to the reference biological, the Ministry of Health issues the import licence on the basis of appraising the dossier and the advice of the council with the function of advising on the issuance of medicine import licences.

For dossiers requesting import licences under Points c and d, Clause 1, Article 57 of this Decree, where no amendment or supplementation of the dossier is required, from the date stated on the Dossier Receipt Slip, within 60 days for dossiers not requiring clinical data or documents proving similarity to the reference biological, or 90 days for dossiers requiring clinical data or documents proving similarity to the reference biological, the provincial People's Committee issues the import licence on the basis of appraising the dossier and the advice of the council with the function of advising on the issuance of medicine import licences;

d) Where amendment or supplementation of the dossier is required, from the date stated on the Dossier Receipt Slip, within 60 days for dossiers not requiring clinical data or documents proving similarity to the reference biological, or 90 days for dossiers requiring clinical data or documents proving similarity to the reference biological, the agency receiving the dossier sends the establishment a document requesting amendment or supplementation of the dossier, using Form No. 16 in Appendix I issued with this Decree;

dd) After receiving the amended or supplemented dossier, the agency receiving the dossier gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, from the date stated on the Dossier Receipt Slip, within 60 days for dossiers not requiring clinical data or documents proving similarity to the reference biological, or 90 days for dossiers requiring clinical data or documents proving similarity to the reference biological, the agency receiving the dossier issues a written notice to the establishment that the import licence is not issued, using Form No. 16 in Appendix I issued with this Decree. Where no amendment or supplementation of the amended or supplemented dossier is required, the agency receiving the dossier issues the import licence under Point c of this Clause;

e) Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation, the establishment requesting the import licence must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid;

g) Where medicines are imported without being able to provide the documents specified at Points d, dd, e, g, h and i, Clause 2, Article 57 of this Decree but are necessary for treatment needs, the Ministry of Health or the provincial People's Committee considers and decides on the basis of the advice of the council with the function of advising on the issuance of medicine import licences, the commitment of the medicine aid provider that the medicines are licensed for circulation in the country of manufacture, an ICH member country, or Australia, and the commitment of the aid-receiving establishment to take responsibility for the safety and efficacy of the medicines;

h) The time limit for issuing import licences or issuing written notices of amendment or supplementation for dossiers requesting import licences for new medicines, rare medicines, vaccines prequalified by the World Health Organization, high-technology medicines, and medicines clinically tested in Vietnam under Articles 51, 52 and 55 of this Decree is given priority and shortened by 10 days compared with the time limit for issuing import licences or for issuing written notices of amendment or supplementation specified at Points c, d and dd of this Clause.

3. Procedures and time limits for issuing import licences for medicines under Clauses 2 and 4, Article 53 of this Decree:

a) The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, within 03 working days from the date stated on the Dossier Receipt Slip, the Ministry of Health issues the import licence;

d) Where amendment or supplementation of the dossier is required, within 03 working days from the date stated on the Dossier Receipt Slip, the Ministry of Health issues a written notice to the establishment, using Form No. 16 in Appendix I issued with this Decree;

dd) After receiving the amended or supplemented dossier, the Ministry of Health gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not yet meet the requirements, the Ministry of Health issues a written notice to the establishment under Point d of this Clause. Where no amendment or supplementation of the amended or supplemented dossier is required, the Ministry of Health issues the import licence under Point c of this Clause;

e) Where the importing establishment cannot provide the documents specified at Point b, Clause 2 or Point b, Clause 3, Article 53 of this Decree but they are necessary for disease prevention and treatment needs, the Minister of Health considers and decides on the basis of the request and the own responsibility of the relevant Ministries.

4. Procedures and time limits for issuing import licences for medicines under Clause 3, Article 53 of this Decree:

a) The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, within 07 working days from the date stated on the Dossier Receipt Slip, the Ministry of Health issues a decision approving the medicines for urgent needs in epidemic prevention and control and remedying the consequences of natural disasters and catastrophes and issues the medicine import licence on the basis of appraising the dossier and the advice of the council with the function of advising on the issuance of medicine import licences;

d) Where amendment or supplementation of the dossier is required, within 07 working days from the date stated on the Dossier Receipt Slip, the Ministry of Health issues a written notice to the establishment, using Form No. 16 in Appendix I issued with this Decree;

dd) After receiving the amended or supplemented dossier, the Ministry of Health gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not yet meet the requirements, the Ministry of Health issues a written notice to the establishment under Point d of this Clause. Where no amendment or supplementation of the amended or supplemented dossier is required, the Ministry of Health approves and issues the import licence under Point c of this Clause;

e) Where the importing establishment cannot provide the documents specified at Point b, Clause 3, Article 53 of this Decree but they are necessary for disease prevention and treatment needs, the Minister of Health considers and decides.

5. Procedures and time limits for issuing import licences for medicines specified in Article 54, Article 56, Points a and b, Clause 1, Article 57, Article 58 and Article 59 of this Decree:

a) The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health, for import of medicines specified in Articles 54 and 56 of this Decree, except where otherwise provided by law.

The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health or the provincial People's Committee of the locality where the establishment has its head office under the roadmap specified in Article 123 of this Decree, for import of medicines specified at Points a and b, Clause 1, Article 57, Article 58 and Article 59 of this Decree;

b) After receiving the dossier, the agency receiving the dossier gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues the import licence;

d) Where amendment or supplementation of the dossier is required, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier sends the establishment a document requesting amendment or supplementation of the dossier, using Form No. 16 in Appendix I issued with this Decree;

dd) After receiving the amended or supplemented dossier, the agency receiving the dossier gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a written notice to the establishment that the import licence is not issued, using Form No. 16 in Appendix I issued with this Decree. Where no amendment or supplementation of the amended or supplemented dossier is required, the agency receiving the dossier issues the import licence under Point c of this Clause;

e) Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation, the establishment requesting the import licence must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid;

g) The time limit for issuing import licences or issuing written notices of amendment or supplementation for dossiers requesting import licences for new medicines, rare medicines, vaccines prequalified by the World Health Organization, high-technology medicines, and medicines clinically tested in Vietnam under Articles 54 and 56 of this Decree is given priority and shortened by 05 days compared with the time limit for issuing import licences or for issuing written notices of amendment or supplementation specified at Points c, d and dd of this Clause.

6. Procedures and time limits for issuing import licences for medicines specified in Article 60 of this Decree:

a) The organisation or individual requesting an import licence submits the dossier directly, via postal services, or online to the provincial People's Committee of the locality of the border gate where entry procedures are carried out, or where the patient resides or temporarily resides lawfully, or where the organisation has its head office;

b) After receiving the dossier, the provincial People's Committee gives the requesting organisation or individual a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, within 07 working days from the date stated on the Dossier Receipt Slip, the provincial People's Committee issues the import licence;

d) Where amendment or supplementation of the dossier is required, within 07 working days from the date stated on the Dossier Receipt Slip, the provincial People's Committee sends the organisation or individual a document requesting amendment or supplementation of the dossier, using Form No. 16 in Appendix I issued with this Decree;

dd) After receiving the amended or supplemented dossier, the provincial People's Committee gives the organisation or individual a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, within 07 working days from the date stated on the Dossier Receipt Slip, the provincial People's Committee issues a written notice to the organisation or individual that the import licence is not issued, using Form No. 16 in Appendix I issued with this Decree. Where no amendment or supplementation of the amended or supplemented dossier is required, the provincial People's Committee issues the import licence under Point c of this Clause;

e) Within 03 months from the date the provincial People's Committee issues the written notice of amendment or supplementation, the organisation or individual requesting the import licence must submit the amended or supplemented dossier as required. After that period, if the organisation or individual has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

7. Within 05 working days from the date of issuing an import licence for medicines under Articles 51, 52, 53, 54 and 55 of this Decree, the Ministry of Health is responsible for announcing it on the web portal of the Ministry of Health under Clause 6, Article 60 of the Law on Pharmacy.

8. The medicine import licence templates are prescribed in Form No. 28, 29, 30, 31 or 32 in Appendix III issued with this Decree.

Article 63. Management of import of medicines without a marketing authorisation in Vietnam

1. The supply of medicines without a marketing authorisation licensed for import under Articles 51, 54 and 55 of this Decree is carried out as follows:

a) Medicines imported under Articles 51 and 55 of this Decree are supplied directly or through medicine wholesale establishments to medical examination and treatment establishments and vaccination establishments;

b) Medicines imported under Article 54 of this Decree are supplied directly or through medicine wholesale establishments to the medical examination and treatment establishment or vaccination establishment named in the import licence or the official letter permitting import, except in the case of medicine transfer under Clause 1, Article 85 of this Decree.

2. Medicines without a marketing authorisation imported under Article 56 of this Decree must be quality-tested by a State medicine and medicinal ingredient testing establishment according to the quality standards of the reference brand-name medicine having a marketing authorisation in Vietnam before being circulated on the market.

3. A medical examination and treatment establishment or vaccination establishment using medicines or vaccines imported under Article 54 of this Decree is responsible for informing the user, the patient or the patient's representative of the information that the medicine is licensed for import but its full legal and technical dossier cannot be provided. The medicine may be used only after the consent of the user, the patient or the patient's representative.

4. Medicines licensed for import to serve State health programmes, clinical trials, and research, testing and verification work must be used for the proper purpose and proper beneficiaries.

5. For specially controlled medicines licensed for import to serve humanitarian medical examination and treatment activities, if not fully used in the programme, the establishment must export them under Clause 5, Article 46 of this Decree and must not use them for other purposes.

6. Medicines licensed for import for display at exhibitions and fairs related to medicine, pharmacy and medical equipment under Article 59 of this Decree must be fully re-exported after the exhibition or fair ends and must not be used or circulated in Vietnam.

7. An individual or organisation requesting import of medicines for non-commercial purposes under Article 60 of this Decree is responsible for the origin and quality of the imported medicines.

8. Within 01 year from the date of importing medicines without a marketing authorisation in Vietnam specified in Article 51 of this Decree, the importing establishment sends a report on the use of the imported medicines to the Ministry of Health, using Form No. 48 in Appendix III issued with this Decree.

Article 64. Provisions on import of medicines meeting needs for prevention and treatment of group A infectious diseases for which an epidemic has been declared under the law on prevention and control of infectious diseases

1. An establishment that has submitted a dossier requesting an import licence for medicines may register the customs declaration and bring the goods back for storage in the importing establishment's warehouses meeting Good Storage Practice for medicines and medicinal ingredients, consistent with the storage conditions stated on the label, while awaiting the licence, and provides information to the border-gate customs authority on the place where the goods will be stored for supervision and management.

2. The customs authority clears a medicine lot only when the importing establishment provides a complete customs clearance dossier as prescribed.

3. The importing establishment is responsible for the following:

a) Reporting to the Ministry of Health on the registered customs declaration within 02 working days from the time of registering the customs declaration;

b) Urgently completing the dossier requesting a medicine import licence as prescribed where the licensing agency requests amendment or supplementation of the dossier;

c) Submitting the import licence to the customs authority within 30 days from the date of registering the customs declaration; where the import licence cannot be provided after that period, the establishment reports to the Ministry of Health so that the Ministry of Health issues a written notice to the customs authority for management and supervision;

d) Keeping the products in their original condition and circulating them only after customs clearance and in compliance with Article 103 of the Law on Pharmacy.

Section 3. IMPORT OF SPECIALLY CONTROLLED MEDICINES HAVING A MARKETING AUTHORISATION IN VIETNAM, AND SPECIALLY CONTROLLED MEDICINAL INGREDIENTS

Article 65. Dossier requesting an import licence for specially controlled medicines having a marketing authorisation in Vietnam

A dossier requesting an import licence for narcotic medicines, psychotropic medicines, precursor medicines, combination medicines containing narcotic active pharmaceutical ingredients, combination medicines containing psychotropic active pharmaceutical ingredients, combination medicines containing precursors, radioactive medicines, toxic medicines, and medicines on the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields having a valid marketing authorisation in Vietnam includes the following documents:

1. 01 original import Order, using Form No. 33, or 03 original import Orders, using Form No. 34 in Appendix III issued with this Decree.

2. A report on the results of trading the imported medicines, using Form No. 18 in Appendix III issued with this Decree, except for toxic medicines.

3. For specially controlled medicines other than toxic medicines, where the total quantity of medicines requested for import, the quantity in stock at the time of preparing the Order, and the quantity that can still be imported under previously issued import licences exceed 150% of the total actual business demand in the immediately preceding reporting period, an explanatory document must be provided together with documents proving the approved bidding results, or the sale and purchase contract, or the framework contract accompanied by a purchase order clearly stating the name, marketing authorisation number and quantity of the medicine, except in the case of first-time import of the medicine, in which case the expected business plan for the medicine requested for import is provided instead.

4. The number of dossiers under this Article is 01 set.

Article 66. Dossier and provisions on issuing import licences for specially controlled medicinal ingredients

1. Dossier requesting import of specially controlled medicinal ingredients:

a) 01 original import Order, using Form No. 35, or 03 original import Orders, using Form No. 36 or Form No. 41 in Appendix III issued with this Decree;

b) A copy of the manufacturer's quality standards and testing methods for the medicinal ingredient, stamped by the importing establishment;

c) A certified copy of the manufacturing licence of the ingredient manufacturing establishment or the Good Manufacturing Practice certificate for ingredients issued by the competent foreign regulatory authority. The manufacturing licence and Good Manufacturing Practice certificate must be consularly legalised under the law on consular legalisation, except where exempted under law;

d) A report on the use of medicinal ingredients, using Form No. 37 in Appendix III issued with this Decree, except in the case of importing toxic medicinal ingredients, and a report on the results of trading medicines and semi-finished medicine products produced from medicinal ingredients, using Form No. 38 in Appendix III issued with this Decree, except in the case of importing toxic medicinal ingredients.

The report on trading results under this point need not be submitted where the ingredients are imported for testing or research of medicines and medicinal ingredients;

dd) A plan for producing, using and trading the ingredients requested for import and an expected business plan for medicines and semi-finished medicine products produced from the ingredients requested for import, except in the case of importing toxic medicinal ingredients.

The expected business plan for finished products produced from the ingredients requested for import under this point need not be submitted where the ingredients are imported for testing or research of medicines and medicinal ingredients.

For specially controlled ingredients other than toxic medicinal ingredients, where the total quantity of ingredients requested for import, the quantity in stock at the time of preparing the Order, and the quantity that can still be imported under previously issued import licences exceed 150% of the total actual business and use demand in the immediately preceding reporting period, documents must be provided proving the approved bidding results, or the sale and purchase contract, or the framework contract accompanied by a purchase order clearly stating the name and quantity of the corresponding medicines and medicinal ingredients, except for import for testing or research of medicines and medicinal ingredients and first-time import;

e) Where ingredients are imported for testing or research of medicines and medicinal ingredients; toxic medicinal ingredients and medicinal ingredients that are radioactive substances; active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields imported to produce medicines or semi-finished medicine products for export; or medicinal ingredients having a marketing authorisation in Vietnam or used to produce medicines or semi-finished medicine products already having a marketing authorisation in Vietnam, the documents specified at Points b and c of this Clause need not be submitted;

g) The original of a document from the importing establishment explaining the purpose and quantity of the imported ingredients and a commitment to use them for the proper purpose, in the case of importing medicinal ingredients for testing or research;

h) Where specially controlled medicinal ingredients without a marketing authorisation in Vietnam, or not on the list of active pharmaceutical ingredients, excipients and semi-finished medicine products for producing medicines under a drug registration dossier already having a marketing authorisation in Vietnam, are imported for production or compounding to serve treatment needs at a medical examination and treatment establishment, the dossier must additionally include an application from the compounding establishment, using Form No. 39 in Appendix III issued with this Decree.

2. If the documents specified at Points b and c, Clause 1 of this Article are not in Vietnamese or English, a translation of them into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed.

3. The number of dossiers under Clauses 1 and 2 of this Article is 01 set.

4. Medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines are not licensed for import for display at exhibitions and fairs.

5. Import of toxic medicinal ingredients and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields for display at exhibitions and fairs is carried out under Article 69 of this Decree.

Article 67. Procedures and time limits for issuing import licences for specially controlled medicines having a marketing authorisation in Vietnam and specially controlled medicinal ingredients

1. The establishment requesting an import licence submits the dossier directly, via postal services, or online to:

a) The Ministry of Health or the provincial People's Committee of the locality where the establishment has its head office under the roadmap specified in Article 123 of this Decree, for dossiers requesting import licences for specially controlled medicines having a marketing authorisation in Vietnam;

b) The Ministry of Health, for dossiers requesting import licences for specially controlled medicinal ingredients.

2. After receiving the dossier, the agency receiving the dossier gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree.

3. Where no amendment or supplementation of the dossier is required, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues the import licence.

4. Where amendment or supplementation of the dossier is required, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a written reply, using Form No. 16 in Appendix I issued with this Decree, requesting amendment or supplementation of the dossier.

5. After receiving the amended or supplemented dossier, the agency receiving the dossier gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a written reply clearly stating the reasons for not issuing the import licence, using Form No. 16 in Appendix I issued with this Decree. Where no amendment or supplementation of the amended or supplemented dossier is required, the agency receiving the dossier issues the import licence under Clause 3 of this Article.

6. Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation, the establishment requesting the import licence must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

7. The time limit for issuing import licences or issuing written notices of amendment or supplementation for dossiers requesting import licences for new medicines, rare medicines, high-technology medicines, and medicines clinically tested in Vietnam under Article 65 of this Decree is given priority and shortened by 05 days compared with the time limit for issuing import licences or issuing written notices of amendment or supplementation specified in Clauses 3, 4 and 5 of this Article.

8. The templates of import licences for medicines and medicinal ingredients are prescribed in Forms No. 28, 29, 30, 40, 43 and 44 in Appendix III issued with this Decree.

Section 4. IMPORT OF MEDICINAL INGREDIENTS WITHOUT A MARKETING AUTHORISATION IN VIETNAM, EXCEPT SPECIALLY CONTROLLED MEDICINAL INGREDIENTS

Article 68. Criteria and dossier for requesting an import licence for active pharmaceutical ingredients, medicinal herbs, semi-finished medicine products, semi-finished medicinal herb products, excipients and capsule shells for testing or research of medicines or compounding of medicines at medical examination and treatment establishments

1. Active pharmaceutical ingredients, medicinal herbs, semi-finished medicine products, semi-finished products for producing medicines of medicinal herb origin in the form of extracts, granules, powders, essences, essential oils, resins, gums and jellies (hereinafter collectively referred to as semi-finished medicinal herb products), excipients and capsule shells without a marketing authorisation in Vietnam are granted an import licence when they fall within one of the following cases:

a) Used in testing and research at manufacturing establishments, at establishments that have been issued an Investment Registration Certificate for medicine production but have not yet been issued a Certificate of Eligibility for Pharmaceutical Business, or at establishments testing and researching medicines and medicinal ingredients;

b) Used in production and compounding to serve treatment needs at medical examination and treatment establishments.

2. The dossier requesting an import licence includes the following documents:

a) 03 original import Orders, using Form No. 36 or 41 in Appendix III issued with this Decree;

b) A copy of the manufacturer's quality standards and testing methods for the medicinal ingredient, stamped by the importing establishment, for importing ingredients under Point b, Clause 1 of this Article;

c) A certified copy of the manufacturing licence of the ingredient manufacturing establishment or the Good Manufacturing Practice certificate for ingredients issued by the competent foreign regulatory authority, for importing ingredients under Point b, Clause 1 of this Article. The manufacturing licence and Good Manufacturing Practice certificate must be consularly legalised under the law on consular legalisation, except where exempted under law;

d) An application from the medical examination and treatment establishment, using Form No. 42 in Appendix III issued with this Decree, for importing ingredients under Point b, Clause 1 of this Article;

dd) If the documents specified at Points b and c of this Clause are not in Vietnamese or English, a translation of them into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed.

3. The number of dossiers under this Article is 01 set.

Article 69. Provisions on import of active pharmaceutical ingredients, semi-finished medicine products, medicinal herbs and semi-finished medicinal herb products for display at exhibitions and fairs

1. Medicinal ingredients are licensed for import for display only at exhibitions and fairs related to medicine, pharmacy and medical equipment.

2. Import of medicinal ingredients for display at exhibitions and fairs must comply with the law on temporary import and re-export.

3. Medicinal ingredients licensed for import under this Article must not be circulated in Vietnam and must be fully re-exported after the exhibition or fair ends.

Article 70. Dossier requesting an import licence for active pharmaceutical ingredients, semi-finished medicine products, medicinal herbs, semi-finished medicinal herb products, excipients and capsule shells for producing medicines for export

1. The dossier consists of 03 original import Orders, using Form No. 36 or 41 in Appendix III issued with this Decree.

2. The number of dossiers under this Article is 01 set.

Article 71. Criteria and dossier for requesting an import licence for active pharmaceutical ingredients, semi-finished medicine products, medicinal herbs and semi-finished medicinal herb products for producing medicines to meet national defence and security requirements, meet needs for prevention and treatment of group A infectious diseases for which an epidemic has been declared under the law on prevention and control of infectious diseases, and remedy the consequences of incidents, natural disasters and catastrophes

1. Medicinal ingredients are licensed for import to produce medicines in one of the following cases:

a) Meeting national defence requirements;

b) Meeting security requirements;

c) Meeting needs for prevention and treatment of group A infectious diseases for which an epidemic has been declared under the law on prevention and control of infectious diseases, and remedying the consequences of incidents, natural disasters and catastrophes.

2. The dossier includes the following documents:

a) 03 original import Orders, using Form No. 36 or 41 in Appendix III issued with this Decree;

b) Where medicinal ingredients are imported to produce medicines meeting national defence and security requirements, the dossier must include the original of a request document from the Ministry of National Defence or the Ministry of Public Security. The document must contain at least the following information: medicine name, name of the medicine manufacturing establishment, active ingredient, concentration or content, dosage form, packaging specification, route of administration, and indications;

c) Where medicinal ingredients are imported to produce medicines meeting needs for prevention and treatment of group A infectious diseases for which an epidemic has been declared under the law on prevention and control of infectious diseases, and remedying the consequences of incidents, natural disasters and catastrophes, the dossier must include the Ministry of Health's document approving the List of medicines. The document must contain at least the following information: medicine name, name of the medicine manufacturing establishment, active ingredient, concentration or content, dosage form, packaging specification, route of administration, and indications;

d) A copy of the manufacturer's quality standards and testing methods for the medicinal ingredient, stamped by the importing establishment;

dd) A certified copy of the manufacturing licence of the ingredient manufacturing establishment or the Good Manufacturing Practice certificate for ingredients issued by the competent foreign regulatory authority. The manufacturing licence and Good Manufacturing Practice certificate must be consularly legalised under the law on consular legalisation, except where exempted under law;

e) If the documents specified at Points d and dd of this Clause are not in Vietnamese or English, a translation of them into Vietnamese or English must additionally be submitted, with the translator's signature certified as prescribed.

3. The number of dossiers under this Article is 01 set.

Article 72. Dossier requesting an import licence for medicinal herbs not falling within the cases specified in Articles 68, 69, 70 and 71 of this Decree

1. The dossier requesting an import licence includes the following documents:

a) 03 original import Orders, using Form No. 41 in Appendix III issued with this Decree;

b) Quality standards of the medicinal herb consistent with the national technical regulation on the corresponding medicinal herb in the Vietnamese Pharmacopoeia or a foreign pharmacopoeia recognised by the Ministry of Health.

Where the national technical regulation on the corresponding medicinal herb is not in the Vietnamese Pharmacopoeia or a foreign pharmacopoeia recognised by the Ministry of Health, the establishment provides quality standards, including the test methods developed by the establishment, that have been appraised by a State medicine and medicinal ingredient testing establishment;

c) A certified copy of the Licence for establishing a Representative Office in Vietnam of the foreign establishment supplying medicinal herbs to Vietnam, with a business scope covering medicinal herbs and preliminarily processed or processed medicinal herbs;

d) A certified and consularly legalised copy of the Pharmaceutical Business Licence issued by the competent authority of the host country as prescribed. Where the host country does not issue a Pharmaceutical Business Licence to the establishment supplying medicinal herbs or semi-finished medicinal herb products, the establishment submits a certified copy of the Business Licence or an equivalent legal document issued by the competent authority of the host country with a business scope covering medicinal herbs. The foreign establishment supplying medicinal herbs or semi-finished medicinal herb products is not required to comply with Article 78 of this Decree if it has all the documents stated in this Clause;

dd) A certified and consularly legalised copy of the Good Manufacturing Practice certificate of the manufacturing establishment issued by the competent authority of the host country as prescribed. Where the host country does not issue a Good Manufacturing Practice certificate, the establishment submits a certified copy of the Manufacturing Licence or legal documents equivalent to a Good Manufacturing Practice certificate with a manufacturing scope covering medicinal herbs and semi-finished medicinal herb products;

e) A copy, stamped by the importing establishment, of the authorisation document from the medicinal herb manufacturing establishment to the foreign medicine supplier, except where the manufacturer is itself the supplier. The authorisation document is as prescribed at Point dd, Clause 1, Article 78 of this Decree.

2. The number of dossiers under this Article is 01 set.

Article 73. Procedures and time limits for issuing import licences for medicinal ingredients without a marketing authorisation in Vietnam, except specially controlled medicinal ingredients

1. Procedures and time limits for issuing import licences for medicinal ingredients specified in Articles 68, 70 and 72 of this Decree:

a) The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health or the provincial People's Committee of the locality where the establishment has its head office under the roadmap specified in Article 123 of this Decree;

b) After receiving the dossier, the agency receiving the dossier gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues the import licence;

d) Where amendment or supplementation of the dossier is required, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier sends the establishment a document requesting amendment or supplementation of the dossier, using Form No. 16 in Appendix I issued with this Decree;

dd) After receiving the amended or supplemented dossier, the agency receiving the dossier gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, within 15 days from the date stated on the Dossier Receipt Slip, the agency receiving the dossier issues a written notice to the establishment that the import licence is not issued, using Form No. 16 in Appendix I issued with this Decree. Where no amendment or supplementation of the amended or supplemented dossier is required, the receiving agency issues the import licence under Point c of this Clause;

e) Within 06 months from the date the agency receiving the dossier issues the written notice of amendment or supplementation, the establishment requesting the import licence must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

2. For cases of importing medicinal ingredients specified in Article 71 of this Decree:

a) The establishment requesting an import licence submits the dossier directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation of the dossier is required, within 03 working days from the date stated on the Dossier Receipt Slip, the Ministry of Health issues the import licence;

d) Where amendment or supplementation of the dossier is required, within 03 working days from the date stated on the Dossier Receipt Slip, the Ministry of Health issues a written reply to the establishment requesting amendment or supplementation of the dossier, using Form No. 16 in Appendix I issued with this Decree;

dd) After receiving the amended or supplemented dossier, the Ministry of Health gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not yet meet the requirements, the Ministry of Health issues a written notice to the establishment under Point d of this Clause. Where no amendment or supplementation of the amended or supplemented dossier is required, the Ministry of Health issues the import licence under Point c of this Clause.

3. The template of the import licence for medicinal ingredients is prescribed in Form No. 43 or 44 in Appendix III issued with this Decree.

Section 5. PROVISIONS ON EXPORT AND IMPORT OF MEDICINES AND MEDICINAL INGREDIENTS

Article 74. Provisions on the validity period of export and import licences for medicines and medicinal ingredients

1. Export licences for medicines and medicinal ingredients have the following validity periods:

a) At most 01 year for medicines and medicinal ingredients licensed for export under Articles 43, 45 and 46, Clause 1, Article 47 and Article 48 of this Decree;

b) At most 02 years for medicines and medicinal ingredients licensed for export under Article 44 and Clause 5, Article 82 of this Decree.

2. Import licences for medicines and medicinal ingredients have the following validity periods:

a) At most 01 year for medicine import licences;

b) At most 01 year and valid for 01 import, for import licences for narcotic medicines, psychotropic medicines, precursor medicines, and medicinal ingredients that are narcotic active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursors used as medicines;

c) At most 02 years for import licences for medicinal ingredients, except medicinal ingredients specified at Point b of this Clause.

3. The validity period of the licence must be specifically stated in the licence.

Article 75. Provisions on the remaining shelf life of imported medicines and medicinal ingredients at the time of customs clearance

1. Chemical medicines, herbal medicines, traditional medicines and medicinal ingredients imported into Vietnam, except medicines and medicinal ingredients specified in Clause 3 of this Article, must have a minimum remaining shelf life at the time of customs clearance as follows:

a) 18 months, where the medicine or medicinal ingredient has a shelf life of more than 24 months;

b) 1/2 of the shelf life, where the medicine or medicinal ingredient has a shelf life of 24 months or less, except the case specified at Point c of this Clause;

c) 1/3 of the shelf life, where the medicine or medicinal ingredient has a shelf life of 9 months or less, except the case specified at Point d of this Clause;

d) Medicines with a shelf life of 30 days or less must still be within their shelf life at the time of customs clearance.

2. Vaccines and biologicals imported into Vietnam, except the cases specified in Clause 3 of this Article, must have a minimum remaining shelf life of 1/2 of the shelf life at the time of customs clearance.

3. Medicines and medicinal ingredients imported under Article 53, Clause 1, Article 54, Articles 58, 59, 60, 68, 69, 70 and 71 of this Decree; medicines imported under Clause 5a, Article 60 of the Law on Pharmacy; and medicinal ingredients imported under Article 66 of this Decree to serve testing, research, or the production of medicines for export must still be within their shelf life at the time of customs clearance.

4. Where medicines or medicinal ingredients have a remaining shelf life at the time of customs clearance shorter than the remaining shelf life specified at Points a, b and c, Clause 1 or Clause 2 of this Article but are necessary for use in production and for disease prevention and treatment, the provincial People's Committee of the locality where the importing establishment has its head office decides to permit import when the medicines or medicinal ingredients fall within one of the following cases:

a) There is no medicine with the same active ingredient and route of administration having a valid marketing authorisation in Vietnam;

b) There is a written request and commitment from the medical examination and treatment establishment on the necessity of using the medicine for disease prevention and treatment needs, but the medicine with the same active ingredient and route of administration granted a marketing authorisation cannot be supplied;

c) Medicinal ingredients for producing medicines falling under Point b of this Clause, but the ingredient manufacturer cannot supply them.

5. The dossier requesting permission to import medicines and medicinal ingredients specified in Clause 4 of this Article includes the following documents:

a) An application from the importing establishment, containing the following information: the name of the medicine or medicinal ingredient, lot number, quantity, remaining shelf life at the time of customs clearance, the reason why the medicine or medicinal ingredient has a remaining shelf life at the time of customs clearance shorter than that specified at Point a, b or c, Clause 1 or Clause 2 of this Article, and its necessity for production and for disease prevention and treatment;

b) A written request and commitment from the medical examination and treatment establishment on the necessity of using the medicine for disease prevention and treatment needs, for the case specified in Clause 4 of this Article, and documents proving that the medicine or medicinal ingredient lot has a remaining shelf life at the time of customs clearance shorter than that specified at Point a, b or c, Clause 1 or Clause 2 of this Article.

c) The number of dossiers under this Clause is 01 set.

6. Order and procedures for permitting import of medicines and medicinal ingredients specified in Clause 4 of this Article:

a) The establishment requesting permission to import submits the dossier directly, via postal services, or online to the provincial People's Committee of the locality where the establishment has its head office;

b) After receiving the dossier, the provincial People's Committee gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Where no amendment or supplementation is required, within 15 days from the date stated on the Dossier Receipt Slip, the provincial People's Committee issues a written approval, using Form No. 51 in Appendix III issued with this Decree;

d) Where amendment or supplementation of the dossier is required, within 15 days from the date stated on the Dossier Receipt Slip, the provincial People's Committee issues a written reply, using Form No. 16 in Appendix I issued with this Decree, requesting amendment or supplementation of the dossier;

dd) After receiving the amended or supplemented dossier, the provincial People's Committee gives the establishment a Receipt Slip for the amended or supplemented dossier using Form No. 01 in Appendix I issued with this Decree. Where the amended or supplemented dossier does not meet the requirements, within 15 days from the date stated on the Dossier Receipt Slip, the provincial People's Committee issues a written reply clearly stating the reasons for not permitting import, using Form No. 16 in Appendix I issued with this Decree. Where no amendment or supplementation of the amended or supplemented dossier is required, the provincial People's Committee issues a written approval under Point c of this Clause;

e) Within 03 months from the date the provincial People's Committee issues the written notice of amendment or supplementation, the establishment requesting permission to import must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid.

Article 76. Provisions on the quantity of medicines and medicinal ingredients licensed for import

1. The quantity of medicines and medicinal ingredients imported under Articles 51, 55, 65 and 66 of this Decree is approved based on the business demand of the establishment requesting import.

2. The quantity of medicines imported under Articles 52 and 54 of this Decree is approved based on the treatment demand of the medical examination and treatment establishment.

3. The quantity of medicines imported under Article 53 of this Decree is approved based on the demand for use for security, national defence, epidemic prevention and control, and remedying the consequences of natural disasters and catastrophes.

4. The quantity of medicines imported under Article 56 of this Decree is approved based on the ability to meet the price stabilisation objective.

5. The quantity of medicines imported under Article 57 of this Decree is approved based on the actual demand for use of the aid-receiving unit.

6. The quantity of medicines imported under Article 58 of this Decree is approved based on the explanatory research outline, or the approved research outline for clinical trials or bioequivalence testing of medicines, or on the establishment's demand for use of medicines in testing and research.

7. The quantity of medicines imported under Article 60 of this Decree is based on the actual demand for use in treatment of the organisation or individual.

8. The quantity of medicinal ingredients imported under Articles 68, 70, 71 and 72 of this Decree is based on the establishment's demand for use of ingredients in production and business.

Article 77. Provisions on the Certificate of Analysis of lots of imported medicines and medicinal ingredients

1. The Certificate of Analysis must be in Vietnamese or English. Where the Certificate of Analysis is not in Vietnamese or English, a translation into Vietnamese or English must be provided, with the translator's signature certified as prescribed.

2. Where 02 or more establishments participate in manufacturing the medicine, the imported lot of medicines or medicinal ingredients must have the Certificate of Analysis of the manufacturer, of the final packaging establishment, or of the establishment responsible for batch release.

3. The Certificate of Analysis must include the following information:

a) The name and address of the manufacturing establishment, the Certificate of Analysis number, the name and signature of the person assigned responsibility, and the date of issue of the Certificate of Analysis;

Where the Certificate of Analysis uses an electronic signature, it must comply with the law on electronic transactions.

Where the Certificate of Analysis does not bear the signature of the person assigned responsibility, a Certificate of Analysis bearing the confirmation stamp of the importing establishment is accepted. The importing establishment is fully responsible before law for the accuracy and validity of the Certificate of Analysis;

b) Information on the sample of medicine or medicinal ingredient, including: product name; lot number; shelf life of the medicine, or shelf life or retest period of the medicinal ingredient; applicable quality standards; quality criteria; quality requirements; test results; and conclusion on the quality of the product lot.

Article 78. Provisions on establishments supplying medicines and medicinal ingredients

1. An establishment supplying medicines and medicinal ingredients is a foreign establishment that signs a sale and purchase contract with the importing establishment. The establishment supplying medicines and medicinal ingredients must be one of the following establishments:

a) The establishment manufacturing the imported medicines and medicinal ingredients;

b) The establishment that owns the product or owns the marketing licence of the imported medicine or active pharmaceutical ingredient stated on the Certificate of Pharmaceutical Product, for medicines granted a marketing authorisation under the Law on Pharmacy and medicines without a marketing authorisation in Vietnam;

c) A foreign establishment named as the registrant of a medicine or medicinal ingredient having a marketing authorisation in Vietnam that is valid at the time of customs clearance but is not an establishment specified at Points a and b of this Clause;

d) An establishment announced by the Ministry of Health at the request of the competent foreign authority of the place where the establishment has its head office;

dd) Where the supplying establishment is not an establishment specified at Points a and b of this Clause, it must be authorised in writing by an establishment specified at Point a or b of this Clause to supply medicines into Vietnam.

The authorisation document includes a letter of authorisation, a sales licence, or a partnership certificate. The authorisation document must be in Vietnamese or English and contain at least the following information: the name and address of the authorising establishment and the authorised establishment; the scope of authorisation including the activity of supplying medicines and medicinal ingredients into Vietnam; the authorisation period or sales permission period; the responsibilities of the parties in ensuring the quality and origin of the medicines and medicinal ingredients supplied into Vietnam; and the confirming signatures of the parties;

e) An establishment supplying medicines imported under Articles 53, 58 and 59 of this Decree is not required to be one of the establishments specified at Points a, b, c or d of this Clause;

g) An establishment supplying medicines imported under Articles 54 and 56 of this Decree need not comply with Point dd of this Clause.

2. Establishments supplying excipients; capsule shells; packaging in direct contact with medicines; specially controlled medicinal ingredients imported for testing, research or production of medicines for export under Article 66 of this Decree; medicinal ingredients imported under Articles 68, 69, 70 and 71 of this Decree; and aid and humanitarian aid medicines need not comply with Clause 1 of this Article.

Article 79. Announcement of establishments permitted to supply medicines and medicinal ingredients into Vietnam at the request of the competent foreign authority of the place where the establishment has its head office

1. The competent foreign authority of the place where the establishment has its head office sends a document to the Ministry of Health requesting announcement of establishments supplying medicines and medicinal ingredients into Vietnam. The request document must meet the following provisions:

a) It must clearly state the name, address and contact information of the competent foreign authority of the place where the establishment has its head office; information on the country or territory registered to supply medicines and medicinal ingredients into Vietnam; and the name of the supplying establishment, business location, business scope and contact information of the medicine and medicinal ingredient business establishments requesting permission to supply medicines and medicinal ingredients into Vietnam;

b) It must be an original in English or Vietnamese. Where it is not in English or Vietnamese, a translation into English or Vietnamese must additionally be provided, with the translator's signature certified as prescribed.

2. The competent foreign authority of the place where the establishment has its head office specified in Clause 1 of this Article is responsible for notifying the Ministry of Health in writing as follows:

a) Where a medicine and medicinal ingredient supplying establishment currently announced by the Ministry of Health changes its name, business location or business scope: notify within 01 month from the date of the document of the competent foreign authority of the place where the establishment has its head office approving the change of information;

b) Where an establishment notifies suspension or termination of medicine and medicinal ingredient business activities in the foreign country where it has its head office: notify within 15 days from the date of the document of the competent foreign authority on the suspension or termination of the supplying establishment's activities.

3. Where the Ministry of Health receives a document from the competent foreign authority of the place where the establishment has its head office requesting announcement of a medicine and medicinal ingredient business establishment requesting permission to supply medicines and medicinal ingredients into Vietnam, the Ministry of Health acts as follows:

a) Within 30 days from the date of receiving the request document of the competent foreign authority of the place where the establishment has its head office, the Ministry of Health announces the information specified at Point a, Clause 1 of this Article on the web portal of the Ministry of Health;

b) Where the Ministry of Health receives a document from the competent foreign authority of the place where the establishment has its head office requesting a change or supplement of information relating to a foreign medicine and medicinal ingredient supplying establishment already announced by the Ministry of Health, the Ministry of Health acts under Point a of this Clause.

Article 80. Cases of revoking import licences for medicines and medicinal ingredients

1. A medicine import licence is revoked in the following cases:

a) The imported medicine is recalled due to a level 1 violation under Point a, Clause 2, Article 63 of the Law on Pharmacy;

b) The marketing authorisation of the imported medicine is revoked by the competent authority of the country of manufacture, an ICH member country, or Australia;

c) The competent authority concludes that documents in the approved dossier requesting a medicine import licence are forged documents;

d) The imported medicine is manufactured at an address other than that in the approved dossier requesting a medicine import licence;

dd) A medicine containing an imported active pharmaceutical ingredient or medicinal herb is warned by the World Health Organization, or the competent regulatory authority of Vietnam or of the country of origin of the medicine, as unsafe or ineffective for users;

e) The manufacturing establishment or importing establishment requests revocation of the import licence for medicines and medicinal ingredients;

g) There is a recall notice from a foreign pharmaceutical regulatory authority for the imported medicine lot;

h) The imported medicine fails to comply with the provisions on medicine supply in Clause 1, Article 63 of this Decree.

2. A medicinal ingredient import licence is revoked in the following cases:

a) The medicinal ingredient is recalled under Points a, b, d, dd or e, Clause 2, Article 62 of the Law on Pharmacy;

b) An imported active pharmaceutical ingredient or medicinal herb is warned by the World Health Organization, or the competent regulatory authority of Vietnam or of the country of origin of the active pharmaceutical ingredient or medicinal herb, as unsafe or ineffective for users.

Article 81. Provisions on reporting on export and import of medicines and medicinal ingredients, except specially controlled medicines

1. Within 10 days from the date of importing a vaccine already having a marketing authorisation in Vietnam, the importing establishment sends a report on each imported consignment to the Ministry of Health and the National Institute for Control of Vaccines and Biologicals, using Form No. 46 in Appendix III issued with this Decree.

2. Within 10 days from the date of importing a medicine without a marketing authorisation in Vietnam, the importing establishment sends a report on each imported consignment to the Ministry of Health, and also to the import-licensing agency under the roadmap specified in Article 124 of this Decree and, for vaccines, to the National Institute for Control of Vaccines and Biologicals, using Form No. 47 in Appendix III issued with this Decree.

3. Before 15 January each year, establishments engaged in the import and export of medicines and medicinal ingredients submit an annual report on the export and import of medicines and medicinal ingredients, using Form No. 49 in Appendix III issued with this Decree, and send it to the Ministry of Health.

Article 82. Other provisions on export and import of medicines and medicinal ingredients

1. Medicinal ingredients that are active pharmaceutical ingredients, excipients, capsule shells, semi-finished medicine products and semi-finished medicinal herb products without a marketing authorisation, for producing medicines under a drug registration dossier already having a marketing authorisation in Vietnam, are announced on the web portal of the licensing agency using Form No. 45 in Appendix III issued with this Decree within 15 days from the date of issuing or renewing the marketing authorisation in Vietnam. Medicinal ingredients on the announced list may be imported without an import licence, except specially controlled medicinal ingredients.

2. Medicinal ingredients already having a marketing authorisation in Vietnam, including medicinal herbs, semi-finished medicinal herb products, excipients, capsule shells and semi-finished medicine products except specially controlled semi-finished medicine products, may be imported without an import licence.

3. Based on the approved explanatory outline for clinical trial research, the Minister of Health announces the list of medicines used for clinical trials for customs clearance upon import on the web portal of the Ministry of Health, using Form No. 50 in Appendix III issued with this Decree, within 07 working days from the date of approving the explanatory research outline.

4. Traders may import packaging in direct contact with medicines without an import licence from the Ministry of Health.

5. For medicines and medicinal ingredients permitted to be exported without a licence under Clause 5, Article 60 of the Law on Pharmacy where the establishment wishes to be issued an export licence:

a) The dossier requesting an export licence includes the original export Order, using Form No. 14 in Appendix III issued with this Decree, and a copy of the exporting establishment's Certificate of Eligibility for Pharmaceutical Business, certified or stamped by the establishment;

b) The procedures for issuing the export licence are as prescribed in Clause 1, Article 49 of this Decree.

6. Medicines and medicinal ingredients must be imported through international border gates, except medicines imported for non-commercial purposes under Article 60 of this Decree and cases of on-site export and import under law.

7. Medicinal ingredients imported under the Law on Pharmacy and this Decree are not required to carry out chemical declaration procedures.

8. Import of medicinal herbs that are specimens of species on the list of endangered, precious and rare species prioritised for protection, for use as testing samples or for research of medicines, must comply with the law on biodiversity.

9. Medical and pharmacy training establishments and medicine research and testing establishments may import medicines and medicinal ingredients to serve training, research and testing conducted by the establishment itself.

10. Representative offices in Vietnam of manufacturers, registrants, and marketing licence holders of medicines for clinical trials, bioavailability assessment and bioequivalence testing; and establishments undertaking clinical trials, bioavailability assessment and bioequivalence testing, may import medicines, medicinal ingredients, and packaging in direct contact with medicines to serve clinical trials, bioavailability assessment, bioequivalence testing, and research and testing of medicines and medicinal ingredients.

11. Agencies and organisations specified in Article 35 of the Law on Pharmacy that comply with the principles and standards of Good Storage Practice for medicines are permitted to:

a) Import medicines falling within the case specified in Article 53 of this Decree when designated by the Ministry of National Defence, the Ministry of Public Security or the Ministry of Health in the document requesting import;

b) Import aid and humanitarian aid medicines when approved by the competent State management agency to receive the aid or humanitarian aid.

12. Medical examination and treatment establishments that have a Drug and Therapeutics Council and meet Article 35 of the Law on Pharmacy are permitted to import medicines to serve special treatment needs of the establishment's patients. The criteria and dossier for requesting an import licence for medicines are as prescribed in Article 54 of this Decree.

13. The list of medicines and medicinal ingredients prohibited from import and production is as prescribed in Appendix V of this Decree.

14. Receipt of dossiers requesting licences and issuance of import licences for medicines and medicinal ingredients are suspended for an importing establishment in the following cases, except dossiers requesting import of medicines under Articles 53, 54 and 55 of this Decree:

a) Violations of Points a, c, d and h, Clause 1, Article 80 of this Decree;

b) Within 12 months, 02 or more imported medicine lots are compulsorily recalled for a level 2 quality violation under Point b, Clause 2, Article 63 of the Law on Pharmacy, or 03 or more imported medicine lots are compulsorily recalled for failing to meet quality standards;

c) Information in the dossier requesting an import licence is not based on actual research or production by the manufacturing establishment.

15. Import of all medicines and medicinal ingredients of a medicine and medicinal ingredient manufacturing establishment is suspended when that establishment commits one of the following acts:

a) Seriously violating the principles and standards of Good Manufacturing Practice as prescribed by the Minister of Health;

b) Within 12 months, 02 or more lots of medicines or medicinal ingredients are compulsorily recalled for a level 1 quality violation under Point a, Clause 2, Article 63 of the Law on Pharmacy relating to the quality of medicines or medicinal ingredients;

c) Within 12 months, 03 or more lots of medicines or medicinal ingredients are compulsorily recalled for a level 2 quality violation under Point b, Clause 2, Article 63 of the Law on Pharmacy, or 04 or more lots of medicines or medicinal ingredients are compulsorily recalled for failing to meet quality standards.

16. The period of suspension of receipt of dossiers requesting licences, suspension of issuance of import licences for medicines and medicinal ingredients, or suspension of import of medicines and medicinal ingredients for an establishment under Clauses 14 and 15 of this Article is as follows:

a) From 01 year to 02 years, for the cases specified in Clause 14 and Points a and b, Clause 15 of this Article, from the date the regulatory agency issues the document applying the management measure;

b) From 06 months to 01 year, for the cases specified at Point c, Clause 15 of this Article, from the date the regulatory agency issues the document applying the management measure.

17. The sale of medicines without a marketing authorisation by an importing establishment that is a foreign-invested pharmaceutical business establishment must comply with Article 53a of the Law on Pharmacy and the provisions of this Decree.

Article 83. Provisions on specialised documents that pharmaceutical business establishments, organisations and individuals must submit when clearing exports and imports of medicines and medicinal ingredients through customs

In addition to the documents required to be submitted under the law on customs, pharmaceutical business establishments, organisations and individuals must submit the following documents when clearing exports and imports of medicines and medicinal ingredients through customs:

1. Customs clearance for export of medicines and medicinal ingredients:

a) Submit the original, a certified copy, or a copy stamped and confirmed by the exporting establishment, of the exporting establishment's Certificate of Eligibility for Pharmaceutical Business, where the exporting establishment is a pharmaceutical business establishment;

b) Submit the original, a certified copy, or a copy of the export licence stamped and confirmed by the exporting establishment, in the case of exporting medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties, and specially controlled medicines, except the case specified at Point c of this Clause;

c) Submit the original or a copy of the prescription or outpatient treatment record book, certified, or a copy signed by the person requesting the export licence, or a copy stamped by the organisation requesting the export licence, falling within one of the cases specified in Clause 2, Article 46 of this Decree.

2. Customs clearance for import of medicines and medicinal ingredients having a marketing authorisation in Vietnam, and medicinal ingredients on the list of active pharmaceutical ingredients, excipients, capsule shells, semi-finished medicine products and semi-finished medicinal herb products under a drug registration dossier already having a marketing authorisation in Vietnam, except medicinal herbs:

a) Submit the original, a certified copy, or a copy stamped and confirmed by the importing establishment, of the importing establishment's Certificate of Eligibility for Pharmaceutical Business, where the importing establishment is a pharmaceutical business establishment;

b) Submit the original, a certified copy, or a copy of the import licence stamped and confirmed by the importing establishment, in the case of importing specially controlled medicines;

c) Submit the original or a copy of the Certificate of Analysis for each imported lot of medicines and medicinal ingredients, stamped by the importing establishment;

d) Submit a copy of the letter of authorisation, sales licence or partnership certificate under Point dd, Clause 1, Article 78 of this Decree, stamped and confirmed by the importing establishment, except in the case of importing excipients, capsule shells, and aid and humanitarian aid medicines;

dd) Where medicines or medicinal ingredients are imported under Point dd, Clause 1, Article 59 of the Law on Pharmacy and an import licence is not required, the importing establishment submits the bill of lading of the lot showing that the goods were shipped from the port of departure of the exporting country before the date on which the marketing authorisation expires, in order to be cleared through customs;

e) Where medicines or medicinal ingredients are imported under Point dd, Clause 1, Article 59 of the Law on Pharmacy and an import licence is required, the importing establishment submits the bill of lading of the lot showing that the goods were shipped from the port of departure of the exporting country before the date on which the marketing authorisation and the import licence expire, in order to be cleared through customs;

g) Where medicinal ingredients on the list of active pharmaceutical ingredients, excipients, capsule shells, semi-finished medicine products and semi-finished medicinal herb products for producing medicines under a drug registration dossier already having a marketing authorisation in Vietnam are imported and an import licence is not required, the importing establishment submits the bill of lading of the lot of medicinal ingredients showing that the goods were shipped from the port of departure of the exporting country before the date on which the marketing authorisation of the medicine used to announce the ingredients expires, in order to be cleared through customs (where the marketing authorisation of the medicine used to announce the ingredients has expired at the time of customs clearance);

h) Where medicinal ingredients on the list of active pharmaceutical ingredients, excipients, capsule shells, semi-finished medicine products and semi-finished medicinal herb products for producing medicines under a drug registration dossier already having a marketing authorisation in Vietnam are imported and an import licence is required, the importing establishment submits the bill of lading of the lot of medicinal ingredients showing that the goods were shipped from the port of departure of the exporting country before the date on which the marketing authorisation of the medicine used to announce the ingredients and the ingredient import licence expire, in order to be cleared through customs (where the marketing authorisation of the medicine used to announce the ingredients or the ingredient import licence has expired at the time of customs clearance);

i) Submit evidence that the notice of medicine import under Clause 1, Article 87 of this Decree has been sent to the provincial People's Committee of the locality of the international border gate through which the medicines are imported. This document need not be submitted when the National Single Window Portal is connected with the information technology system for handling customs procedures for exported and imported goods and for means of transport on entry, exit and transit.

3. Customs clearance for import of medicinal herbs and semi-finished medicinal herb products with or without a marketing authorisation in Vietnam, except semi-finished medicinal herb products for producing medicines under a drug registration dossier already having a marketing authorisation in Vietnam:

a) Submit the original, a certified copy, or a copy stamped and confirmed by the importing establishment, of the Certificate of Eligibility for Pharmaceutical Business for comparison, where the importing establishment is a pharmaceutical business establishment;

b) For medicinal herbs and semi-finished medicinal herb products having a marketing authorisation in Vietnam, submit the original, a certified copy, or a copy of the marketing authorisation stamped by the importing establishment;

c) For medicinal herbs and semi-finished medicinal herb products without a marketing authorisation in Vietnam, submit the original, a certified copy, or a copy stamped by the importing establishment, of the medicinal herb import licence;

d) A copy, stamped by the importing establishment, of the authorisation document from the manufacturing establishment of the medicinal herbs or semi-finished medicinal herb products to the foreign medicine supplier, except where the manufacturer is itself the supplier. The authorisation document is as prescribed at Point dd, Clause 1, Article 78 of this Decree;

dd) Submit the original or a copy of the manufacturer's Certificate of Analysis for each imported lot of medicinal herbs or semi-finished medicinal herb products, stamped by the importing establishment;

e) Where medicinal herbs or semi-finished medicinal herb products are imported under Point dd, Clause 1, Article 59 of the Law on Pharmacy and an import licence is not required, the importing establishment submits the bill of lading of the lot of medicinal herbs or semi-finished medicinal herb products showing that the goods were shipped from the port of departure of the exporting country before the date on which the marketing authorisation expires;

g) For medicinal herbs and semi-finished medicinal herb products imported under Articles 68 and 69 of this Decree, the documents specified at Points b, d, dd and e of this Clause are not required;

h) Where medicinal herbs or semi-finished medicinal herb products are imported under Point dd, Clause 1, Article 59 of the Law on Pharmacy and an import licence is required, the importing establishment submits the bill of lading of the lot of medicinal herbs or semi-finished medicinal herb products showing that the goods were shipped from the port of departure of the exporting country before the date on which the marketing authorisation and the import licence expire, in order to be cleared through customs;

i) Where medicinal herbs or semi-finished medicinal herb products are imported under an import licence for products without a marketing authorisation in Vietnam and the import licence has expired at the time of customs clearance, the importing establishment submits the bill of lading of the lot of medicinal herbs or semi-finished medicinal herb products showing that the goods were shipped from the port of departure of the exporting country before the date on which the import licence expires, in order to be cleared through customs.

4. Customs clearance for import of medicines and medicinal ingredients without a marketing authorisation in Vietnam, except the cases specified in Clauses 2 and 3 of this Article:

a) Submit the original, a certified copy, or a copy stamped and confirmed by the importing establishment, of the importing establishment's Certificate of Eligibility for Pharmaceutical Business, where the importing establishment is a pharmaceutical business establishment;

b) Submit the original, a certified copy, or a copy stamped and confirmed by the importing establishment, of the import licence for medicines and medicinal ingredients; except for medicines without a marketing authorisation in Vietnam used for clinical trials that are not specially controlled medicines, and medicines without a marketing authorisation in Vietnam used for State health programmes that are not aid medicines;

c) Submit the original or a copy of the Certificate of Analysis for each imported lot of medicines and medicinal ingredients, stamped and confirmed by the importing establishment, in the case of importing medicines and medicinal ingredients under Article 51; Article 52; Clause 2, Article 54; Article 55; Points c and d, Clause 1, Article 57; Article 65; Article 66; Point b, Clause 1, Article 68; Article 70 and Article 71 of this Decree;

d) Submit a copy of the prescription or outpatient treatment record book, certified, or signed by the person entering the country, or a copy stamped by the importing organisation, falling within one of the cases specified in Clause 2, Article 60 of this Decree;

dd) Submit a copy of the letter of authorisation, sales licence or partnership certificate under Point dd, Clause 1, Article 78 of this Decree, stamped and confirmed by the importing establishment, except for medicines imported under Articles 53, 54, 56, 57, 58 and 59 of this Decree, packaging in direct contact with medicines, specially controlled medicinal ingredients imported to produce medicines for export under Article 66 of this Decree, medicinal ingredients licensed for import under Articles 68, 69, 70 and 71 of this Decree, and specially controlled medicinal ingredients imported for testing and research;

e) Where medicines or medicinal ingredients are imported under an import licence for products without a marketing authorisation in Vietnam and the import licence has expired at the time of customs clearance, the importing establishment submits the bill of lading of the lot of medicines or medicinal ingredients showing that the goods were shipped from the port of departure of the exporting country before the date on which the import licence expires, in order to be cleared through customs;

g) Where medicines without a marketing authorisation in Vietnam are imported for use in State health programmes and are not aid medicines, the importing establishment presents the document of the competent State management agency approving the use of the medicines for State health programmes.

Section 6. PROVISIONS ON CHANGING THE PURPOSE OF USE OF INGREDIENTS FOR PRODUCING MEDICINES AND ON TRANSFER OF MEDICINES MEETING URGENT NEEDS FOR NATIONAL DEFENCE AND SECURITY, EPIDEMIC PREVENTION AND CONTROL, AND REMEDYING THE CONSEQUENCES OF NATURAL DISASTERS AND CATASTROPHES, AND SPECIAL TREATMENT NEEDS

Article 84. Dossier, procedures and processing time for changing the purpose of use of active pharmaceutical ingredients and medicinal herbs for producing medicines granted a marketing authorisation with an indication for prevention and treatment of group A infectious diseases for which an epidemic has been declared under the law on prevention and control of infectious diseases, for active pharmaceutical ingredients and medicinal herbs already licensed for import for other purposes

1. Dossier requesting a change of the purpose of use of active pharmaceutical ingredients and medicinal herbs:

A notice from the medicine manufacturing establishment on changing the purpose of use of active pharmaceutical ingredients and medicinal herbs, using Form No. 52 in Appendix III issued with this Decree.

2. Procedures and processing time for changing the purpose of use of active pharmaceutical ingredients and medicinal herbs:

a) The medicine manufacturing establishment sends the Notice directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the requesting establishment a Dossier Receipt Slip using Form No. 01 in Appendix I issued with this Decree;

c) Within 05 working days from the date of receiving the dossier, the Ministry of Health considers and issues a written notice to the establishment permitting the change of purpose of use as requested by the manufacturing establishment, if the information on the active pharmaceutical ingredients and medicinal herbs requested for change matches the information on the active pharmaceutical ingredients and medicinal herbs for production under the announced drug registration dossier already having a marketing authorisation in Vietnam. Where permission is not granted, the reasons must be clearly stated.

Article 85. Provisions on transfer of medicines without a marketing authorisation in Vietnam imported to meet urgent needs for national defence and security, epidemic prevention and control, remedying the consequences of natural disasters and catastrophes, and special treatment needs

1. For medicines imported to meet special treatment needs:

a) A medical examination and treatment establishment that has imported or purchased medicines or vaccines imported to serve its own special treatment needs may transfer the medicines or vaccines for the special treatment needs of another medical examination and treatment establishment that has a Drug and Therapeutics Council, or another vaccination establishment nationwide;

b) A pharmaceutical business establishment that has imported medicines or vaccines for the special treatment needs of a medical examination and treatment establishment or vaccination establishment may transfer the medicines or vaccines for the special treatment needs of another medical examination and treatment establishment that has a Drug and Therapeutics Council, or another vaccination establishment nationwide;

c) The medical examination and treatment establishment or vaccination establishment receiving the transferred medicines or vaccines must provide the documents specified at Points c, d and dd, Clause 3, Article 54 of this Decree in full to the importing establishment, or to the medical examination and treatment establishment or vaccination establishment holding the medicines or vaccines to be transferred, before receiving the transfer.

2. For medicines imported to meet urgent needs for national defence and security, epidemic prevention and control, and remedying the consequences of natural disasters and catastrophes:

a) Medicines without a marketing authorisation in Vietnam imported to meet urgent needs for national defence and security, epidemic prevention and control, and remedying the consequences of natural disasters and catastrophes may be transferred to serve disease prevention and treatment needs;

b) The transfer of the medicines specified in this Clause is carried out under the law on management and use of public property and other relevant law;

c) The establishment using the transferred medicines is responsible for the safety, efficacy and quality of the medicines after receiving the transfer, ensuring use in accordance with the approved indications of the medicines.

Section 7. PROVISIONS ON MEDICINES SUBJECT TO IMPORT CONTROL

Article 86. Types of medicines subject to import control

Medicines already having a marketing authorisation in Vietnam are subject to import control under Articles 87 and 88 of this Decree, except in the following cases:

1. Medicines meeting needs for prevention and treatment of group A infectious diseases for which an epidemic has been declared under the law on prevention and control of infectious diseases.

2. Medicines with a shelf life of less than 30 days.

Article 87. Provisions on import notification

1. At least 05 working days before carrying out customs declaration procedures, the importing establishment must notify the provincial People's Committee of the locality where the medicines are imported of the following information on the imported medicine lot:

a) Medicine name, active ingredient, content, dosage form, packaging specification;

b) Name and address of the manufacturing establishment;

c) Marketing authorisation number;

d) Date of manufacture and shelf life;

dd) Manufacturing lot number;

e) Actual imported quantity and unit of measurement;

g) Import border gate and expected import date;

After completing the notification, the importing establishment is given a receipt code for the notice. The importing establishment is responsible before law for the accuracy and truthfulness of the content of the notice.

Where there is a change to the notified information, the importing establishment must make a new notification under this Clause, and the new Notice must state: “This Notice replaces the Notice with receipt code No. …” (stating the receipt code of the old Notice).

2. Within 05 working days from receiving the importing establishment's notice, the provincial People's Committee reviews the information on the imported medicines under the notice that has been given a receipt code and compares it with the information on medicines granted a marketing authorisation announced on the web portal of the Ministry of Health, under the following criteria:

a) The information on the imported medicine specified at Points a, b, c and d, Clause 1 of this Article in the notice must match the information on the medicine granted a marketing authorisation in Vietnam;

b) The medicine must have a valid marketing authorisation in Vietnam, or continue to use the marketing authorisation under Point c, Clause 8, Article 56 of the Law on Pharmacy, at the time of sending the Notice;

c) There must be no recommendation from the competent State agency on suspending or ceasing import of the medicine into Vietnam.

3. Where the medicine does not meet one of the criteria specified in Clause 2 of this Article at the time of sending the Notice, within 05 working days from the date of receiving the content of the Notice, the provincial People's Committee issues a written notice of the unmet content to the customs authority at the border gate where the medicine is imported, for consideration of customs clearance under law, and at the same time notifies the medicine importing establishment so that it reviews, adjusts and re-submits the notification as prescribed.

4. After 05 working days from the date the importing establishment completes the notification procedure, if the provincial People's Committee has not issued a written notice under Clause 3 of this Article, the importing establishment may carry out customs procedures under law.

Where, after customs clearance, the provincial People's Committee discovers that the imported medicine lot does not meet Point c, Clause 2 of this Article, it is responsible for notifying the Ministry of Health and the importing establishment in writing so that the suspension of trading and use is carried out under Clause 6, Article 77 of the Law on Pharmacy.

5. The customs authority checks the customs dossier under Article 32 of the Law on Customs and other provisions of the law on customs.

6. The customs authority does not permit customs clearance of an imported medicine lot in one of the following cases:

a) The provincial People's Committee has issued a written notice under Clause 3 of this Article, except where the imported medicine is permitted to remain in circulation under Point dd, Clause 1, Article 59 of the Law on Pharmacy;

b) The medicine lot has been notified for import for less than 05 working days as of the time of carrying out customs procedures.

c) Other cases under law.

7. The activities specified in Clauses 1, 2, 3 and 4 of this Article are carried out online, integrated on the National Single Window Portal under the roadmap specified in Clause 2, Article 125 of this Decree.

Article 88. Provisions on testing to determine medicine quality before circulation

1. Medicines subject to import control specified in Article 86 of this Decree that fall within the cases specified in Clause 3, Article 103 of the Law on Pharmacy must be tested and determined to meet quality requirements before being circulated.

2. Testing of medicines to determine medicine quality before circulation is carried out under Clauses 3, 4 and 5, Article 103 of the Law on Pharmacy.

3. An imported medicine lot that must be tested to determine quality before circulation under Clause 1 of this Article must be stored in a warehouse of the importing establishment meeting the principles and standards of Good Storage Practice for medicines and medicinal ingredients, for sampling for quality testing.

4. Where test results fail to meet requirements, the importing establishment notifies the provincial People's Committee of the locality where the medicines are imported of the test results within 03 working days from the date of receiving the test results from the testing establishment.

5. An imported medicine lot with test results not meeting quality requirements is handled under regulations of the Minister of Health and relevant law.

Chapter V

REGISTRATION FOR CIRCULATION OF MEDICINAL HERBS, EXCIPIENTS AND CAPSULE SHELLS; REGULATIONS ON THE NUMBER OF MARKETING AUTHORISATIONS; AND ASSESSMENT OF OVERSEAS MEDICINE AND MEDICINAL INGREDIENT MANUFACTURING ESTABLISHMENTS

Section 1. REGISTRATION FOR CIRCULATION OF MEDICINAL HERBS, EXCIPIENTS AND CAPSULE SHELLS; REGULATIONS ON THE NUMBER OF MARKETING AUTHORISATIONS

Article 89. Subjects of and requirements for registration for circulation of medicinal herbs, excipients and capsule shells

1. Medicinal herbs falling within one of the following cases must be registered before being circulated in Vietnam:

a) Medicinal herbs used as medicines in Vietnam for the first time;

b) Semi-finished medicinal herb products, except where these products are produced by the establishment itself to produce finished medicines, or semi-finished medicinal herb products for producing medicines under a drug registration dossier already having a marketing authorisation in Vietnam, or semi-finished products for testing, research or production of medicines for export.

2. Medicinal herbs not falling under Clause 1 of this Article must have their standards announced under Clause 2, Article 68 of the Law on Pharmacy. Where the establishment wishes to register for circulation, it follows Section 1, Chapter V of this Decree.

3. Medicinal ingredients that are pharmaceutical excipients with in-house standards developed by the excipient manufacturer that do not apply, or are not included in, the Vietnamese Pharmacopoeia or national standards and technical regulations on medicines, or that do not apply a foreign pharmacopoeia in Vietnam under regulations of the Minister of Health, must be registered before being circulated in Vietnam under Section 1, Chapter V of this Decree, except excipients used to produce medicines already granted a valid marketing authorisation in Vietnam, and excipients used for testing, research or production of medicines for export.

4. Medicinal ingredients that are capsule shells must be registered before being circulated in Vietnam under Section 1, Chapter V of this Decree, except capsule shells used to produce medicines already granted a valid marketing authorisation in Vietnam, and capsule shells used for testing, research or production of medicines for export.

5. Establishments permitted to register medicinal herbs, excipients and capsule shells include:

a) Establishments specified in Clause 3, Article 54 of the Law on Pharmacy;

b) Establishments specified at Point c, Clause 1, Article 35 of the Law on Pharmacy are permitted to register medicinal herbs.

6. The form of registration, and the rights and responsibilities of establishments registering medicinal herbs, excipients and capsule shells, are as prescribed in Articles 55 and 57 of the Law on Pharmacy.

Article 90. Competence, dossier, procedures and time limits for issuing, renewing, changing, supplementing and revoking marketing authorisations for medicinal herbs, excipients and capsule shells

The competence, dossier, procedures and time limits for issuing, renewing, changing, supplementing and revoking marketing authorisations for medicinal herbs, excipients and capsule shells are as prescribed in Articles 56 and 58 of the Law on Pharmacy, except that an establishment cultivating or harvesting medicinal herbs that does not hold a Certificate of Eligibility for Pharmaceutical Business must submit a certified copy of its Enterprise Registration Certificate when submitting the dossier for registration for circulation of medicinal herbs.

Article 91. Number of marketing authorisations for medicines with the same active pharmaceutical ingredient or medicinal herb

Medicines with the same active pharmaceutical ingredient or medicinal herb, the same dosage form, the same route of administration, and the same content or concentration per dosage unit, manufactured at one manufacturing site of one manufacturing establishment, may be granted at most 02 marketing authorisations, except in the following cases:

1. Medicines for export only, not circulated in Vietnam.

2. Technology-transferred medicines.

3. Contract-manufactured medicines.

4. Non-prescription medicines:

a) For children, in the form of solutions; syrups; powders or granules for suspension; powders or granules for solution, using different flavouring and taste excipients;

b) In the form of lozenges, using different flavouring and taste excipients.

Section 2. ASSESSMENT OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICE OF OVERSEAS MEDICINE AND MEDICINAL INGREDIENT MANUFACTURING ESTABLISHMENTS WHEN REGISTERING FOR CIRCULATION IN VIETNAM

Article 92. Cases of assessing compliance with Good Manufacturing Practice of overseas medicine and medicinal ingredient manufacturing establishments

1. For medicines and medicinal ingredients imported when registering for circulation in Vietnam, overseas medicine and medicinal ingredient manufacturing establishments, including those participating in only one or more production stages, must be assessed for compliance with Good Manufacturing Practice, except in the following cases:

a) The establishment's medicine or medicinal ingredient production line has been assessed by the Ministry of Health of Vietnam as meeting Good Manufacturing Practice under Clause 5, Article 54 of the Law on Pharmacy;

b) A medicine manufacturing establishment for registration for circulation under Point c, Clause 9, Article 56 of the Law on Pharmacy.

2. An overseas medicine and medicinal ingredient manufacturing establishment that has been assessed by the Ministry of Health of Vietnam as meeting Good Manufacturing Practice under Clause 5, Article 54 of the Law on Pharmacy must be assessed to maintain compliance in the following cases:

a) The validity period of the Good Manufacturing Practice compliance certification content for the assessed production line has expired;

b) Change of information on the scope of certification in the Good Manufacturing Practice compliance certification content announced by the Ministry of Health;

c) Change of other information in the Good Manufacturing Practice compliance certification content announced by the Ministry of Health, except the case specified at Point b of this Clause.

Article 93. Provisions on assessing compliance with Good Manufacturing Practice by appraising dossiers relating to manufacturing conditions

1. The form of appraising dossiers relating to manufacturing conditions applies, except in the following cases:

a) Manufacturing establishments falling under the form of recognising or accepting inspection and examination results of the competent authority for Good Manufacturing Practice compliance requirements specified in Clause 1, Article 94 of this Decree;

b) Manufacturing establishments falling under the form of inspection at the manufacturing establishment specified at Points a, b and dd, Clause 1, Article 95 of this Decree.

2. The dossier requesting assessment includes:

a) An application for assessment of Good Manufacturing Practice, using Form No. 01 in Appendix VIII issued with this Decree;

b) The Good Manufacturing Practice certificate or manufacturing licence issued by the competent authority of the host country;

c) The Good Manufacturing Practice inspection report of the most recent inspection issued by the competent authority of the host country;

d) The site master file of the manufacturing establishment under the guidelines of the European Union (EU), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or the World Health Organization;

dd) A list of Good Manufacturing Practice inspections conducted by the competent authority of the host country and competent authorities of other countries (if any) within 03 years from the date of submitting the dossier;

e) The Good Manufacturing Practice certificate and Good Manufacturing Practice inspection report of the manufacturing establishment issued by one of the stringent regulatory authorities (SRA) or a pharmaceutical regulatory authority recognised by the Ministry of Health on the basis of the World Health Organization's classification (if any).

3. Order and procedures for assessment:

a) The establishment requesting assessment of Good Manufacturing Practice compliance submits the dossier directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the requesting establishment a Dossier Receipt Slip using Form No. 02 in Appendix VIII issued with this Decree;

c) The Ministry of Health organises assessment of the dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment within at most 40 days from the date of receipt.

Where the dossier includes the additional document specified at Point e, Clause 2 of this Article, the assessment time is at most 20 days from the date of receipt.

Where the dossier does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

d) Within at most 30 days from the date of receiving the amended or supplemented dossier of the establishment requesting assessment, the Ministry of Health organises assessment of the amended or supplemented dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment.

Where the dossier does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

dd) Within at most 30 days from the date of receiving the second amended or supplemented dossier of the establishment requesting assessment, the Ministry of Health organises assessment of the amended or supplemented dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the amended or supplemented dossier does not yet meet, or does not meet, the requirements, the agency receiving the dossier issues a written reply that the dossier does not meet Good Manufacturing Practice and clearly states the reasons;

e) Within 06 months from the date of receiving the Ministry of Health's written reply that Good Manufacturing Practice is not yet met, the requesting establishment must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid;

g) Within 03 working days from the date of the Good Manufacturing Practice compliance assessment result, the Ministry of Health publishes on the web portal of the Ministry of Health information on the assessed manufacturing establishment and the Good Manufacturing Practice principles and standards that the establishment meets.

4. Assessment content:

a) Check the completeness of the dossier under Clause 2 of this Article and Article 97 of this Decree;

b) Compare the scope of certification stated on the Good Manufacturing Practice certificate, the Good Manufacturing Practice inspection report, or the manufacturing licence with the dosage form of the registered medicine or medicinal ingredient;

c) Assess the arrangement of production lines and auxiliary systems; the cleanliness grade of production rooms; and production and testing equipment in the site master file of the manufacturing establishment, except where the establishment's scope of certification stated in the document specified at Point e, Clause 2 of this Article is consistent with the scope requested for assessment;

d) Compare the manufacturing establishment's level of compliance with Good Manufacturing Practice and the shortcomings in the production, testing and storage of medicines and medicinal ingredients found in the Good Manufacturing Practice inspection report.

Article 94. Provisions on assessing Good Manufacturing Practice compliance by mutual recognition and acceptance of inspection and examination results of pharmaceutical State management agencies for Good Manufacturing Practice compliance requirements for medicines and medicinal ingredients

1. The form of mutual recognition and acceptance of inspection and examination results of pharmaceutical State management agencies for Good Manufacturing Practice compliance requirements for medicines and medicinal ingredients applies in the following cases:

a) Manufacturing establishments in countries announced by the Ministry of Health in the list of countries with which Vietnam has signed international treaties on mutual recognition of Good Manufacturing Practice inspection results, on the web portal of the Ministry of Health, except the cases specified at Points a and b, Clause 1, Article 95 of this Decree;

b) Manufacturing establishments in countries whose competent pharmaceutical authority is a stringent regulatory authority (SRA) or a pharmaceutical regulatory authority recognised by the Ministry of Health on the basis of the World Health Organization's classification, and that have been inspected and assessed by one of these authorities as meeting Good Manufacturing Practice, except the cases specified at Points a and b, Clause 1, Article 95 of this Decree.

2. Dossier requesting assessment:

a) An application for assessment of Good Manufacturing Practice, using Form No. 01 in Appendix VIII issued with this Decree;

b) The Good Manufacturing Practice certificate, or manufacturing licence, or Good Manufacturing Practice inspection report where the competent authority of the host country does not issue a Good Manufacturing Practice certificate or manufacturing licence.

3. Order and procedures for assessment:

a) The establishment requesting assessment of Good Manufacturing Practice compliance submits the dossier directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the requesting establishment a Dossier Receipt Slip using Form No. 02 in Appendix VIII issued with this Decree;

c) The Ministry of Health organises assessment of the dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment within at most 20 days from the date of receipt. Where the dossier does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

d) Within at most 15 days from the date of receiving the amended or supplemented dossier of the establishment requesting assessment, the Ministry of Health organises assessment of the amended or supplemented dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the dossier does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

dd) Within at most 15 days from the date of receiving the second amended or supplemented dossier of the establishment requesting assessment, the Ministry of Health organises assessment of the amended or supplemented dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the amended or supplemented dossier does not yet meet, or does not meet, the requirements, the agency receiving the dossier issues a written reply that the dossier does not meet Good Manufacturing Practice and clearly states the reasons;

e) Within 06 months from the date of receiving the Ministry of Health's written reply that Good Manufacturing Practice is not yet met, the requesting establishment must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid;

g) Within 03 working days from the date of the Good Manufacturing Practice compliance assessment result, the Ministry of Health publishes on the web portal of the Ministry of Health information on the assessed manufacturing establishment and the Good Manufacturing Practice principles and standards that the establishment meets.

4. Assessment content and scope:

a) Check the completeness of the dossier under Clause 2 of this Article and Article 97 of this Decree;

b) Compare the scope of certification stated on the Good Manufacturing Practice certificate, the Good Manufacturing Practice inspection report, or the manufacturing licence with the dosage form of the registered medicine or medicinal ingredient;

c) Recognition and acceptance of inspection and examination results for Good Manufacturing Practice compliance covers the scope of certification, the Good Manufacturing Practice principles and standards, and other contents relating to Good Manufacturing Practice and the conditions for producing medicines and medicinal ingredients.

Article 95. Provisions on assessing Good Manufacturing Practice compliance by inspection at the medicine and medicinal ingredient manufacturing establishment

1. The form of inspection at the medicine and medicinal ingredient manufacturing establishment applies in the following cases:

a) The manufacturing establishment has a drug or medicinal ingredient registration dossier showing signs of alteration, or there is doubt about the authenticity of information and data in the dossier;

b) The manufacturing establishment has a medicine with a level 1 quality violation according to the conclusion of the Ministry of Health;

c) The manufacturing establishment has a dossier requesting assessment of manufacturing conditions that the Ministry of Health concluded lacks sufficient grounds to prove that the manufacturing establishment meets Good Manufacturing Practice;

d) The manufacturing establishment of the exporting country applies Good Manufacturing Practice principles and standards inconsistent with the Good Manufacturing Practice principles and standards issued or recognised for application by the Minister of Health;

dd) The manufacturing establishment has medicines or medicinal ingredients registered for circulation in Vietnam for the first time, except manufacturing establishments specified in Clause 1, Article 94 of this Decree or medicine and medicinal ingredient manufacturing establishments already assessed and certified as meeting Good Manufacturing Practice by a stringent regulatory authority (SRA) or a pharmaceutical regulatory authority recognised by the Ministry of Health on the basis of the World Health Organization's classification.

2. Dossier requesting assessment:

a) An application for assessment of Good Manufacturing Practice, using Form No. 01 in Appendix VIII issued with this Decree;

b) The documents specified at Points b, c and d, Clause 2, Article 93 of this Decree.

3. Order and procedures for assessment:

a) The establishment requesting assessment of Good Manufacturing Practice compliance submits the dossier directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the requesting establishment a Dossier Receipt Slip using Form No. 02 in Appendix VIII issued with this Decree;

c) Within at most 90 days from the date of receiving a complete dossier, for the cases specified at Points b, d and dd, Clause 1 of this Article, or from the date of announcing the appraisal result of the drug registration dossier or the dossier requesting assessment of the manufacturing establishment's Good Manufacturing Practice compliance, for the cases specified at Points a and c, Clause 1 of this Article, the Ministry of Health organises assessment and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the manufacturing establishment does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

d) Within at most 40 days from the date of receiving the amended or supplemented dossier, the Ministry of Health organises assessment of the amended or supplemented dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the dossier does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

dd) Within at most 40 days from the date of receiving the second amended or supplemented dossier of the establishment requesting assessment, the Ministry of Health organises assessment of the amended or supplemented dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the amended or supplemented dossier does not yet meet, or does not meet, the requirements, the agency receiving the dossier issues a written reply that the dossier does not meet Good Manufacturing Practice and clearly states the reasons;

e) Within 06 months from the date of receiving the Ministry of Health's written reply that Good Manufacturing Practice is not yet met, the requesting establishment must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid;

g) Within 03 working days from the date of the Good Manufacturing Practice compliance assessment result, the Ministry of Health publishes on the web portal of the Ministry of Health information on the assessed manufacturing establishment and the Good Manufacturing Practice principles and standards that the establishment meets.

4. Assessment content:

a) Check the completeness of the dossier under Clause 2 of this Article and Article 97 of this Decree;

b) Assess the current state of the factory facilities, including the factory layout, production lines, construction materials, production environment conditions, arrangement of movement routes for staff, materials, semi-finished products and finished products, and auxiliary systems; the cleanliness grade of production rooms; and production, testing and storage equipment for medicines and medicinal ingredients;

c) Assess the actual production process of the production line for the registered medicine or medicinal ingredient;

d) Assess the establishment and operation of the manufacturing establishment's quality management system;

dd) Assess the actual state of applying and complying with Good Manufacturing Practice across all production, testing and storage activities for medicines and medicinal ingredients at the manufacturing establishment.

5. Inspection at the manufacturing establishment may be carried out by remote assessment through electronic means where travel is restricted due to epidemics, war or disasters.

Article 96. Provisions on assessing maintenance of Good Manufacturing Practice compliance

1. Provisions on the dossier requesting assessment applicable to Points a and b, Clause 2, Article 92 of this Decree:

a) An application for registration of assessment of maintenance of Good Manufacturing Practice compliance, using Form No. 01 in Appendix VIII issued with this Decree;

b) The Good Manufacturing Practice certificate or manufacturing licence and the Good Manufacturing Practice inspection report of the most recent inspection, for medicine and medicinal ingredient manufacturing establishments assessed under Article 93 of this Decree;

c) The Good Manufacturing Practice certificate, or manufacturing licence, or Good Manufacturing Practice inspection report, for medicine and medicinal ingredient manufacturing establishments assessed under Article 94 of this Decree;

d) The Good Manufacturing Practice certificate or manufacturing licence and the Good Manufacturing Practice inspection report of the most recent inspection, for medicine and medicinal ingredient manufacturing establishments assessed under Article 95 of this Decree;

dd) An updated site master file of the manufacturing establishment where the establishment has changes to the factory premises or to the medicine or medicinal ingredient production lines already assessed as meeting Good Manufacturing Practice, under regulations of the Ministry of Health;

e) Documents relating to the changed information (if any).

2. Provisions on the dossier requesting assessment applicable to Point c, Clause 2, Article 92 of this Decree:

a) An application for registration of assessment of maintenance of Good Manufacturing Practice compliance, using Form No. 01 in Appendix VIII issued with this Decree;

b) Documents relating to the changed information, including legal documents confirmed by the competent authority.

3. Order and procedures for assessment:

a) The establishment requesting assessment of maintenance of Good Manufacturing Practice compliance submits the dossier directly, via postal services, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health gives the requesting establishment a Dossier Receipt Slip using Form No. 02 in Appendix VIII issued with this Decree;

c) The Ministry of Health organises assessment and appraisal of the dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment within at most 20 days from the date of receipt. Where the dossier does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

d) Within at most 15 days from the date of receiving the amended or supplemented dossier of the establishment requesting assessment, the Ministry of Health organises assessment of the supplementary dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the dossier does not yet meet, or does not meet, Good Manufacturing Practice, the written reply must clearly state the reasons;

dd) Within at most 15 days from the date of receiving the second amended or supplemented dossier of the establishment requesting assessment, the Ministry of Health organises assessment of the amended or supplemented dossier and issues a written reply on the status of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the amended or supplemented dossier does not yet meet, or does not meet, the requirements, the agency receiving the dossier issues a written reply that the dossier does not meet Good Manufacturing Practice and clearly states the reasons;

e) Within 06 months from the date of receiving the Ministry of Health's written reply that Good Manufacturing Practice is not yet met, the requesting establishment must submit the amended or supplemented dossier as required. After that period, if the establishment has not submitted the amended or supplemented dossier, the submitted dossier is no longer valid;

g) Within 03 working days from the date of the Good Manufacturing Practice compliance assessment result, the Ministry of Health publishes on the web portal of the Ministry of Health information on the assessed manufacturing establishment and the Good Manufacturing Practice principles and standards that the establishment meets.

4. Assessment content:

a) Check the completeness of the dossier under Clauses 1 and 2 of this Article and Article 97 of this Decree;

b) Compare the scope of certification stated on the Good Manufacturing Practice certificate, the Good Manufacturing Practice inspection report, or the manufacturing licence with the announced scope;

c) Compare the manufacturing establishment's level of compliance with Good Manufacturing Practice and the shortcomings in the production, testing and storage of medicines and medicinal ingredients found in the Good Manufacturing Practice inspection report;

d) Assess the information on changes recorded in the Good Manufacturing Practice inspection report, the state of non-compliance with Good Manufacturing Practice, and the remedying of non-compliance with Good Manufacturing Practice (if any).

5. An overseas medicine and medicinal ingredient manufacturing establishment continues to maintain its Good Manufacturing Practice compliance assessment result in one of the following cases:

a) It has submitted a dossier for assessment of maintenance of Good Manufacturing Practice compliance under Clauses 1 and 2 of this Article;

b) The registrant or the medicine and medicinal ingredient manufacturing establishment provides the result of its own lookup of information on the English-language website or database of the competent authority on Good Manufacturing Practice compliance assessment, or on a website operated by the competent authority of the host country or a regional competent authority, determining that the manufacturing establishment maintains Good Manufacturing Practice compliance. The lookup must be made after the expiry of the Good Manufacturing Practice compliance validity announced on the web portal of the Ministry of Health of Vietnam. The result of the lookup is stamped and confirmed by the registrant or the medicine and medicinal ingredient manufacturing establishment, accompanied by a document providing the lookup link;

c) The registrant and the manufacturing establishment are fully responsible before law for the legality and accuracy of these documents, this information and the result of the establishment's own lookup. The agency or organisation uses the lookup information and carries out the lookup and verification via the link provided by the registrant or the medicine and medicinal ingredient manufacturing establishment.

Article 97. Specific provisions on documents in the dossier requesting assessment, and assessment of maintenance of Good Manufacturing Practice compliance, of medicine and medicinal ingredient manufacturing establishments

1. Documents serving as the basis for assessment:

a) The Good Manufacturing Practice principles and standards for medicines and medicinal ingredients issued or recognised for application by the Minister of Health;

b) Current regulations on registration and quality management of medicines and medicinal ingredients;

c) Where the Good Manufacturing Practice principles and standards are not among those issued or recognised for application by the Minister of Health under Point a, Clause 1 of this Article, the Advisory Council for issuing marketing authorisations for medicines and medicinal ingredients assesses the conformity of the exporting country's principles and standards with the principles and standards issued or recognised for application by the Minister of Health. After a conforming assessment result, the Minister of Health issues a decision recognising the conformity of the exporting country's Good Manufacturing Practice principles and standards as the basis for assessing the manufacturing establishment.

2. The dossier requesting assessment, or assessment of maintenance of Good Manufacturing Practice compliance, of the manufacturing establishment is made in 01 set in English or Vietnamese, in which documents are clearly printed, with dividers between parts, a cover page and a list of documents.

3. Requirements for the Good Manufacturing Practice certificate or manufacturing licence:

a) It must be valid at the time of receiving the dossier;

b) Where no validity period is stated, these documents must have been issued within not more than 03 years from the date of receiving the dossier;

c) Where Points a and b of this Clause are not met, the registrant or the manufacturing establishment provides an explanatory document together with documents proving the Good Practice compliance status of the medicine and medicinal ingredient manufacturing establishment.

4. Requirements for the Good Manufacturing Practice inspection report:

a) The Good Manufacturing Practice inspection report was issued not more than 03 years before the date of receiving the dossier;

b) Where Point a of this Clause is not met, the registrant or the manufacturing establishment provides an explanatory document together with proving documents.

5. Where the competent foreign authority does not issue a Good Manufacturing Practice certificate, manufacturing licence or Good Manufacturing Practice inspection report, the registrant or the medicine and medicinal ingredient manufacturing establishment may substitute other legal documents issued by the competent foreign authority to prove the Good Manufacturing Practice compliance status of the medicine and medicinal ingredient manufacturing establishment.

Specifically, for assessment of Good Manufacturing Practice compliance by recognition and acceptance under Article 94 of this Decree, a Certificate of Pharmaceutical Product accompanied by information on the status of registration of medicine production activities, or information on the most recent Good Manufacturing Practice inspection conducted by the competent authority of the host country, may also be substituted.

6. The documents specified in Clauses 3, 4 and 5 of this Article must show at least the following information: name and address of the issuing agency; document number; the Good Manufacturing Practice principles and standards applied; name and address of the manufacturing establishment; scope of certification of Good Manufacturing Practice compliance; time of inspection and assessment; and time of issue.

7. The documents specified in Clauses 3, 4 and 5 of this Article must be consularly legalised as prescribed, except in the following cases:

a) Provided directly in writing or via the email box of the Ministry of Health by the competent authority of the issuing country;

b) Published by the competent authority of the issuing country, or by a regional competent authority, on a website or published as an English-language database.

The registrant or manufacturing establishment submits the result of its own lookup, stamped and confirmed by the establishment, accompanied by a document providing the lookup link, and is fully responsible before law for the legality and accuracy of the result of its own lookup and the information it provides.

8. The technical procedure for assessing, and assessing maintenance of, Good Manufacturing Practice compliance of overseas medicine and medicinal ingredient manufacturing establishments in order to announce the manufacturing establishment's Good Manufacturing Practice compliance is as prescribed by the Minister of Health.

Article 98. Responsibilities of registrants of medicines and medicinal ingredients in inspecting and assessing Good Manufacturing Practice of foreign medicine manufacturing establishments, and cases of suspending receipt of dossiers for issuing and renewing marketing authorisations for medicines and medicinal ingredients of registrants and medicine and medicinal ingredient manufacturing establishments

1. Specific responsibilities of registrants of medicines and medicinal ingredients in inspecting and assessing Good Manufacturing Practice of foreign manufacturing establishments:

a) Submit, or coordinate with the medicine and medicinal ingredient manufacturing establishment to submit, the dossier requesting assessment, or assessment of maintenance, of Good Manufacturing Practice compliance of the overseas medicine and medicinal ingredient manufacturing establishment as prescribed;

b) Be responsible for ensuring the completeness and accuracy of the dossier requesting assessment of Good Manufacturing Practice compliance; provide additional proving documents as requested by the Ministry of Health;

c) Coordinate with the medicine and medicinal ingredient manufacturing establishment to carry out the Ministry of Health's requirements on inspection and assessment of the manufacturing establishment;

d) Report to the Ministry of Health on the maintenance of Good Manufacturing Practice compliance of the medicine and medicinal ingredient manufacturing establishment. Where the manufacturing establishment has its manufacturing licence revoked or fails to meet Good Manufacturing Practice according to a notice from the competent authority of the host country, or from the certifying authority that is a stringent regulatory authority (SRA) or a pharmaceutical regulatory authority recognised by the Ministry of Health on the basis of the World Health Organization's classification, which assessed the manufacturing establishment under Clause 3, Article 95 of this Decree, the establishment must report within 15 days from the date of the competent authority's notice;

dd) Be responsible for the costs of assessing the manufacturing establishment as prescribed by law.

2. Receipt of dossiers for issuing and renewing marketing authorisations for medicines and medicinal ingredients is suspended when the registrant or the medicine and medicinal ingredient manufacturing establishment commits one of the following violations:

a) The cases of revoking marketing authorisations for medicines and medicinal ingredients specified at Points a, d and dd, Clause 1, Article 58 of the Law on Pharmacy;

b) Producing medicines from ingredients of unknown source or origin, or from expired medicinal ingredients;

c) Having 02 or more lots of medicines or medicinal ingredients compulsorily recalled for failing to meet quality standards at level 2, or 03 or more lots of medicines or medicinal ingredients compulsorily recalled for failing to meet quality standards within 01 year, according to the conclusion of the competent State agency in Vietnam;

d) Providing information relating to the technical dossier that is not based on actual research or production by the manufacturing establishment;

dd) Failing to report to the Ministry of Health within 15 days from the date of the notice of the competent authority of the host country that the manufacturing establishment has had its manufacturing licence revoked or fails to meet Good Manufacturing Practice, or the notice of non-compliance with Good Manufacturing Practice by the competent authority that is a stringent regulatory authority (SRA) or a pharmaceutical regulatory authority recognised by the Ministry of Health on the basis of the World Health Organization's classification under Point d, Clause 1 of this Article, except where the establishment voluntarily requests revocation of the manufacturing licence for commercial reasons;

e) Changing or altering the shelf life of a medicine, except the case specified in Clause 3, Article 61 of the Law on Pharmacy;

g) Failing to report to the Ministry of Health within 15 days from the date of the notice of the competent regulatory authority where a medicine or medicinal ingredient of the registrant is recalled or has its marketing authorisation withdrawn in any country in the world, except where the establishment voluntarily requests recall or withdrawal of the marketing authorisation for commercial reasons;

h) Forging or arbitrarily altering dossiers, documents or legal papers of Vietnamese or foreign competent agencies; using a forged seal or forging the signature or seal of the registrant, the manufacturing establishment and related establishments in the drug registration dossier.

3. The period of suspending receipt of dossiers for issuing and renewing marketing authorisations for medicines and medicinal ingredients, from the date the competent authority issues the notice of the violation:

a) From 03 years to 05 years, for the cases specified at Point d, Clause 1, Article 58 of the Law on Pharmacy and Point h, Clause 2 of this Article;

b) From 01 year to 02 years, for the cases specified at Points a and dd, Clause 1, Article 58 of the Law on Pharmacy and Points b, c, d, dd and e, Clause 2 of this Article;

c) From 06 months to 01 year, for the cases specified at Point b, Clause 1, Article 58 of the Law on Pharmacy and Point g, Clause 2 of this Article.

4. Dossiers requesting issuance or renewal of marketing authorisations for medicines and medicinal ingredients of establishments that commit the violations specified at Points d and h, Clause 2 of this Article, submitted before the date of handling the violation, are no longer valid. When the period of suspending receipt of dossiers specified in Clause 3 of this Article ends, an establishment wishing to register medicines and medicinal ingredients must submit a dossier under the Law on Pharmacy.

Chapter VI

COMPETENCE, FORMS AND PROCEDURES FOR RECALLING MEDICINAL INGREDIENTS, AND MEASURES FOR HANDLING RECALLED MEDICINAL INGREDIENTS

Article 99. Forms and scope of recalling medicinal ingredients

1. Forms of recall:

a) Compulsory recall is recall under a decision of the competent State agency;

b) Voluntary recall is recall carried out voluntarily by the registrant, the manufacturing establishment, or the establishment importing the medicinal ingredient.

2. Scope of recall:

a) The medicinal ingredient is recalled entirely from the establishments trading in and using that medicinal ingredient, except the case specified at Point b of this Clause;

b) Where ingredients fail to meet quality standards due to errors in storage, transport or distribution, or where ingredients are used for the wrong purpose, recall applies only to the affected portion of ingredients at the establishments trading in and using that medicinal ingredient;

c) The scope of recall must be clearly stated in the competent authority's recall decision or in the recall notice of the registrant, the manufacturing establishment, or the importing establishment voluntarily recalling the medicinal ingredient.

Article 100. Competence and procedures for recalling medicinal ingredients

1. Competence to issue recall decisions:

a) The Ministry of Health concludes that an ingredient falls within the cases requiring recall and issues a decision recalling the violating medicinal ingredient in the case of compulsory recall;

b) The domestic medicinal ingredient manufacturing establishment or the medicinal ingredient importing establishment concludes that an ingredient falls within the cases requiring recall and issues a decision recalling the medicinal ingredient in the case of voluntary recall.

2. Procedures for recalling medicinal ingredients:

a) Within not more than 48 hours from the conclusion on recalling the ingredient, the Ministry of Health issues the recall decision, or the establishment specified at Point b, Clause 1 of this Article issues the recall decision and reports to the Ministry of Health on the recall of the violating medicinal ingredient. The recall decision is sent to the domestic medicinal ingredient manufacturing establishment, the ingredient importing establishment, and the provincial People's Committee, and announced on the web portal of the Ministry of Health, in the case of compulsory recall;

b) Within not more than 05 working days from the date of the recall decision, the domestic medicinal ingredient manufacturing establishment or importing establishment must notify the manufacturing and trading establishments that purchased the ingredient of information on the recalled medicinal ingredient, and at the same time organise the recall and receipt of recalled medicinal ingredients returned by the manufacturing and trading establishments;

c) The recall of medicinal ingredients must be completed within 30 days from the date of the recall decision;

d) Within not more than 10 days from the date of completing the recall, the establishment responsible for the recall must send a report on the recall results to the Ministry of Health, accompanied by a copy, stamped by the establishment, of the ingredient recall dossier. The recall dossier includes documents showing the quantity of ingredients produced or imported, the quantity recalled, the time of production, the date of import, the list of establishments that purchased the ingredients, and evidence of carrying out the recall at the trading and using establishments;

dd) The Ministry of Health reviews the recall report results and organises an assessment of recall effectiveness, or coordinates with the Ministry of Public Security and relevant units to enforce the recall where the domestic ingredient manufacturing establishment or the ingredient importing establishment fails to carry out the recall under Point b or c of this Clause.

Article 101. Responsibilities for recalling medicinal ingredients

1. Responsibilities of the domestic manufacturing establishment or the establishment importing the recalled medicinal ingredient:

a) Conclude that the ingredient falls within the cases requiring recall and issue the recall decision for the medicine in the case of voluntary recall;

b) Cease trading in the recalled medicinal ingredient;

c) Take the lead, in coordination with relevant organisations and individuals, in announcing information on the recalled medicinal ingredient and organise the recall and receipt of the recalled medicinal ingredient;

d) Handle the recalled medicinal ingredient;

dd) Pay the costs of recalling and handling the recalled medicinal ingredient (including in the case of enforced recall) and compensate for damage under law;

e) Report to the Ministry of Health on the recall and the recall results of the medicinal ingredient.

2. Responsibilities of the establishment distributing the recalled medicinal ingredient:

a) Cease trading in and distributing the recalled medicinal ingredient;

b) Notify and organise the recall and receipt of the recalled medicinal ingredient returned by manufacturing and using establishments;

c) Return the recalled medicinal ingredient to the establishment that supplied that medicinal ingredient;

d) Pay the costs of recalling and handling the recalled medicinal ingredient (including in the case of enforced recall) and compensate for damage under law where at fault.

3. Responsibilities of the medicine manufacturing establishment using the recalled medicinal ingredient:

a) Cease using the recalled medicinal ingredient;

b) Return the recalled medicinal ingredient to the establishment that supplied the medicinal ingredient.

4. The Ministry of Health has the following responsibilities:

a) Conclude that an ingredient falls within the cases requiring recall and issue a decision recalling the violating medicinal ingredient in the case of compulsory recall;

b) Review recall reports and recall results of manufacturing and trading establishments;

c) Direct provincial People's Committees to inspect and supervise the organisation and implementation of recall of medicinal ingredients and to handle violating establishments in their localities;

dd) Announce information on the recalled medicinal ingredient on the web portal of the Ministry of Health, in the case of recalled medicinal ingredients that must be destroyed.

5. Provincial People's Committees have the following responsibilities:

a) Notify manufacturing and trading establishments in their localities of information on the recall of medicinal ingredients;

b) Inspect and supervise the organisation and implementation of recall of medicinal ingredients in their localities and handle violating units in their localities;

c) Report to the Ministry of Health on cases where manufacturing or trading establishments are found not to carry out, or to carry out incompletely, the recall of medicinal ingredients.

Article 102. Handling of recalled medicinal ingredients

1. Recalled medicinal ingredients that are medicinal herbs or active pharmaceutical ingredients must be destroyed in the following cases:

a) The recalled medicinal ingredient is an ingredient produced for a purpose other than human use but labelled as a medicinal ingredient for human use;

b) The recalled medicinal ingredient is an ingredient whose marketing authorisation for medicinal ingredients was granted on the basis of a forged dossier;

c) The recalled medicinal ingredient is an ingredient of unknown source or origin;

d) The active pharmaceutical ingredient is produced, presented or labelled so as to impersonate the manufacturer, country of manufacture or country of origin;

dd) Counterfeit medicinal herbs;

e) Medicinal herbs without a marketing authorisation or without announced quality standards as prescribed;

g) The recalled medicinal ingredient is an ingredient from which a medicine is produced that the World Health Organization has warned is unsafe or ineffective for medicine users.

2. Recalled medicinal ingredients may be remedied and reused in the following cases:

a) The medicinal ingredient is recalled for failing to meet requirements on the labels of medicines and medicinal ingredients under Article 61 of the Law on Pharmacy or other relevant legal provisions;

b) The medicinal ingredient is recalled because the ingredient was produced at an address other than that in the drug registration dossier but was produced by the same establishment at another address licensed for production by the competent authority.

3. Recalled medicinal ingredients, except ingredients that are psychotropic active pharmaceutical ingredients, narcotic substances, or precursors used as medicines, that do not fall within the cases specified in Clauses 1 and 2 of this Article may be reprocessed, for domestically produced ingredients, or re-exported, for imported ingredients.

Recalled medicinal ingredients specified in this Clause must be destroyed if they are not reprocessed or re-exported.

The manufacturing establishment or importing establishment is responsible for reporting to the Ministry of Health on the reprocessing, re-export or destruction of recalled medicinal ingredients.

4. Reprocessed medicinal ingredients may be circulated and used only when they simultaneously meet the following conditions:

a) The reprocessing is carried out at an establishment meeting Good Manufacturing Practice;

b) The reprocessing method must conform to the production process approved in the drug or medicinal ingredient registration dossier;

c) A State medicine and medicinal ingredient testing establishment concludes that they meet quality standards under the standards approved or accepted by the Ministry of Health.

5. Procedures for destroying medicinal ingredients:

a) The head of the establishment holding the medicinal ingredients to be destroyed issues a decision establishing a Council for destruction of medicinal ingredients. The Council must have at least 03 members, including the head and the person in charge of pharmaceutical professional matters of the establishment;

b) The destruction of medicinal ingredients must ensure long-term safety for people and animals and avoid environmental pollution under the law on environmental protection;

c) The medicinal ingredient trading establishment in violation is responsible for the cost of destroying the medicinal ingredients;

d) The destruction of specially controlled medicinal ingredients must comply with Article 36 of this Decree.

Chapter VII

CONTENT OF MEDICINE ADVERTISEMENTS; DOSSIER, PROCEDURES FOR RECEIVING, APPRAISING AND CONFIRMING THE CONTENT OF MEDICINE ADVERTISEMENTS; RESPONSIBILITIES OF ORGANISATIONS AND INDIVIDUALS CONDUCTING AND PARTICIPATING IN MEDICINE ADVERTISING

Article 103. Provisions on the content of medicine advertisements

1. The content of medicine advertisements must conform to the following documents:

a) The current medicine label and package leaflet approved by the Ministry of Health;

b) The monograph on the medicine in the National Pharmacopoeia Formulary of Vietnam;

c) Documents and professional guidelines relating to medicines issued or recognised by the Ministry of Health;

d) Where the information on the medicine in the documents specified at Points a, b and c of this Clause is inconsistent, the content of the medicine advertisement must be based on the current medicine label and package leaflet approved by the Ministry of Health.

2. The content of medicine advertisements must include the following mandatory information:

a) Medicine name;

b) Composition of active pharmaceutical ingredients or medicinal herbs stated in the approved package leaflet. For medicinal herbs, the Vietnamese name must be written; where there is no Vietnamese name, the Latin name is stated;

c) Indications;

d) Directions for use;

dd) Dosage;

e) Contraindications and recommendations for special groups (pregnant women, breastfeeding women, children, the elderly, people with chronic diseases) (if there is information);

g) Precautions and things to avoid or note when using the medicine;

h) Adverse reactions and undesirable effects of the medicine;

i) Name and address of the medicine manufacturing establishment;

k) The instruction “Read the package leaflet carefully before use”;

l) At the bottom of the first page of the medicine advertisement content, the following must be clearly stated: number of the Certificate confirming the content of the medicine advertisement of … (confirming agency): …/XNQC…, dated … month … year …;

m) For advertisement content of multiple pages, pages must be numbered, and the first page must clearly state how many pages the document has and on which page the detailed product information is found;

n) The content of the medicine advertisement must clearly note the supporting documents and also clearly indicate the part of the information quoted from the supporting documents. Quotation must ensure accurate communication of the information, without inference or truncation of information in a way that misleads about the safety and efficacy of the medicine.

3. The content of medicine advertisements on radio and television must contain all the information specified at Points a, b, c, e, i and k, Clause 2 of this Article, of which the contents specified at Points a, b, c, e and k, Clause 2 of this Article must be read aloud clearly. Where the medicine composition has 03 or more active ingredients, each active ingredient must be read out, or the general name of the groups of vitamins, minerals or medicinal herbs must be read out.

4. Advertisement content on online newspapers, websites, electronic devices, dedicated advertising screens and other advertising means under the law on advertising:

a) Advertisement content with sound must be presented as for radio and television as specified in Clause 3 of this Article;

b) Advertisement content without sound must contain all the information specified in Clause 2 of this Article.

Where the advertisement content is an audio or video recording with multiple pages or advertising scenes, the pages or advertising scenes must appear consecutively and pause long enough for viewers to read all the information shown; pages or scenes with product information content must stay still, without movement, so that readers can study the product information carefully. The script must describe how the content pages appear, for advertisements with multiple pages.

Medicine advertising in this form must be separate, and must not overlap or interleave multiple medicines at the same time, to avoid misunderstanding.

5. The content of medicine advertisements through outdoor advertising means is shown only on the same 01 face of the advertising means and must contain the information specified at Points a, b, i, k and l, Clause 2 of this Article. Where the advertisement content includes information relating to the uses, effects or indications of the medicine, the full information as prescribed in Clause 2 of this Article must be included.

6. The spoken language and script in the content of medicine advertisements must comply with the Law on Advertising.

7. The font size in the content of medicine advertisements must be clear, easy to read and easy to notice, but not smaller than font size 12 of the VnTime or Times New Roman typeface on A4 paper.

8. The advertisement script must clearly describe the visuals, spoken words, text and music.

9. The content of medicine advertisements may provide only information on the medicine and must not include information unrelated to the medicine.

Article 104. Information and images not to be used in the content of medicine advertisements

1. Information and images prohibited in advertising activities under the Law on Advertising.

2. Content that causes misunderstanding about the composition, effects, indications or origin of the medicine.

3. Content that creates the understanding that: this medicine is number one; this medicine is better than all others; using this medicine is the best measure; using this medicine does not require a physician's opinion; this medicine is completely harmless; the medicine has no contraindications; the medicine has no undesirable effects; the medicine has no harmful effects.

4. Sentences, words and images that are overly speculative, leading to misunderstanding as the effects, indications or efficacy of the medicine, or exceeding the effects, indications or efficacy of the medicine as approved.

5. Retaining the effect of each component in the medicine in order to advertise beyond the uses of the medicine or to cause confusion of the effect of each component with the effect of the medicine.

6. The words and phrases: “cure at the root”, “eradicate”, “specialised treatment”, “leading”, “top-ranking”, “first choice”, “choice”, “high quality”, “100% guaranteed”, “safe”, “stop”, “cut off”, “halt”, “immediate relief”, “instant relief”, “instantly relieved”, “cured immediately”, “completely cured”, “peace of mind”, “no worry”, “worry-free”, “recommended”, “hotline” and words and phrases of similar meaning.

7. Indications that must not be included in the content of medicine advertisements:

a) Indications for treating tuberculosis and leprosy;

b) Indications for treating sexually transmitted diseases;

c) Indications for treating insomnia;

d) Aphrodisiac indications;

dd) Indications for treating cancer and tumour diseases;

e) Indications for treating drug-withdrawal symptoms;

g) Indications for treating diabetes or other similar metabolic disorders;

h) Indications for treating viral hepatitis and newly emerging dangerous diseases.

8. Quality test results of medicines and medicinal ingredients.

9. Preclinical research results.

10. Clinical research results or bioequivalence test results not yet recognised by the Ministry of Health.

11. Using the name, position, prestige, letters or thank-you letters of organisations or individuals to advertise medicines.

12. Exploiting the origin of medicines or medicinal ingredients to advertise medicines.

13. Images, names and symbols of health workers.

14. Images of animals and plants on the list of endangered, precious and rare species prioritised for protection.

15. Sentences and words in the nature of tips or word-of-mouth to recommend medicines.

16. Using images of patients to describe a pathological condition or the uses of the medicine inconsistent with documents relating to the medicine and professional guidelines issued or recognised by the Ministry of Health.

Article 105. Issuance, adjustment and correction of certificates confirming the content of medicine advertisements

1. A certificate confirming the content of a medicine advertisement is issued in the following cases:

a) The content of the medicine advertisement for which a certificate is first requested;

b) The content of the medicine advertisement for which a certificate has been issued but has changes not falling within the cases specified in Clause 2 of this Article.

2. The certificate confirming the content of a medicine advertisement is adjusted where the content of the medicine advertisement has the following changes:

a) Information on the medicine registrant or medicine manufacturing establishment;

b) Information on the name and address of the establishment named in the dossier requesting confirmation of the content of the medicine advertisement, without changing the establishment named in that dossier;

c) Change of medicine registrant;

d) Information on the medicine packaging specification; the symbol of the medicine registrant, the establishment named in the dossier requesting confirmation of the content of the medicine advertisement, or the medicine manufacturing establishment, without accompanying words;

dd) The logo of the medicine registrant, the establishment named in the dossier requesting confirmation of the content of the medicine advertisement, or the medicine manufacturing establishment, together with words in the form of a trademark protected as a whole under the Trademark Registration Certificate issued by the competent authority.

3. The Certificate confirming the content of a medicine advertisement is corrected where the information stated on the certificate was written incorrectly due to an error of the agency issuing the certificate.

Article 106. Dossier requesting a certificate confirming the content of a medicine advertisement

1. The dossier requesting a certificate confirming the content of a medicine advertisement, except for medicine advertising through organising seminars, conferences and events introducing medicines, includes the following documents:

a) An application for confirmation of the content of the medicine advertisement, using Form No. 01 in Appendix VI issued with this Decree;

b) The design sample of the content of the medicine advertisement requested for confirmation; an audio or video recording of the advertisement content on radio, television or electronic devices, dedicated advertising screens and other advertising means under the law on advertising with sound and moving images;

c) The current medicine label and package leaflet approved by the Ministry of Health;

d) Reference documents relating to the content of the medicine advertisement requested for confirmation (if any);

dd) A Licence for establishing a Representative Office of a foreign company in Vietnam, for a foreign establishment named in the application for confirmation of the content of the medicine advertisement, or a Certificate of Eligibility for Pharmaceutical Business, for a Vietnamese pharmaceutical business establishment named in the application for confirmation of the content of the medicine advertisement. The Certificate of Eligibility for Pharmaceutical Business issued by the Ministry of Health need not be submitted for a Vietnamese pharmaceutical business establishment named in the application for confirmation of the content of the medicine advertisement;

e) A letter of authorisation from the medicine registrant to the establishment named in the dossier requesting confirmation of the content of the medicine advertisement, in the case of authorisation.

2. The dossier requesting a certificate confirming the content of a medicine advertisement through organising seminars, conferences and events includes the following documents:

a) An application for confirmation of the content of the medicine advertisement, using Form No. 02 in Appendix VI issued with this Decree;

b) The content of the medicine advertisement;

c) The current medicine label and package leaflet approved by the Ministry of Health;

d) Reference documents relating to the content of the medicine advertisement requested for confirmation (if any);

dd) A Licence for establishing a Representative Office of a foreign company in Vietnam, for a foreign establishment named in the application for confirmation of the content of the medicine advertisement, or a Certificate of Eligibility for Pharmaceutical Business, for a Vietnamese pharmaceutical business establishment named in the application for confirmation of the content of the medicine advertisement. The Certificate of Eligibility for Pharmaceutical Business issued by the Ministry of Health need not be submitted for a Vietnamese pharmaceutical business establishment named in the application for confirmation of the content of the medicine advertisement;

e) A letter of authorisation from the medicine registrant to the establishment named in the dossier requesting confirmation of the content of the medicine advertisement, in the case of authorisation;

g) The expected programme of the seminar, conference or event introducing medicines.

3. The number of dossiers under Clauses 1 and 2 of this Article is 01 set.

Article 107. Requirements for the dossier requesting a certificate confirming the content of a medicine advertisement

1. The documents specified at Point c, Clause 1 and Point c, Clause 2, Article 106 of this Decree are copies.

2. The documents specified at Points d and dd, Clause 1 and Points d and dd, Clause 2, Article 106 of this Decree are copies stamped by the establishment requesting confirmation of the content of the medicine advertisement, for documents issued by the Ministry of Health, or certified copies, or copies accompanied by the original for comparison, for documents not issued by the Ministry of Health.

3. The document specified at Point e, Clause 1 and Point e, Clause 2, Article 106 of this Decree is the original, a certified copy, or a copy accompanied by the original for comparison.

4. The documents specified at Point b, Clause 1 and Point b, Clause 2, Article 106 of this Decree are originals and are made in 02 copies.

5. Each dossier requesting a certificate confirming the content of a medicine advertisement is prepared as follows:

a) 01 design sample or audio or video recording of the medicine advertisement content, for the dossier specified in Clause 1, Article 106 of this Decree, or 01 medicine advertisement content, for the dossier specified in Clause 2, Article 106 of this Decree, for one medicine;

b) 01 design sample or audio or video recording of the medicine advertisement content, for the dossier specified in Clause 1, Article 106 of this Decree, or 01 medicine advertisement content, for the dossier specified in Clause 2, Article 106 of this Decree, for two or more medicines with the same active ingredient and route of administration from the same manufacturer but different content or dosage form.

6. Documents are printed on A4 paper. For large-format outdoor advertising, the medicine advertisement content may be presented on A3 paper with the size ratio to the actual size clearly stated. All documents in the dossier must bear the overlapping seal of the establishment requesting confirmation of the content of the medicine advertisement. Where the content design is for an advertising object with a spatial structure, the dossier must include a description on A3 paper of the following mandatory contents:

a) The spatial structure;

b) Sequential numbering of the faces and the size of each face;

c) The size ratio of the design sample to the real object.

7. Establishments permitted to be named in the dossier requesting confirmation of the content of a medicine advertisement include:

a) A medicine registrant in Vietnam;

b) The representative office in Vietnam of the very foreign establishment registering the medicine in Vietnam, authorised by that establishment;

c) A Vietnamese pharmaceutical business establishment authorised by the establishment specified at Point a of this Clause.

8. The medicine registrant, including where it authorises the establishments specified at Points b and c, Clause 7 of this Article to be named in the request for confirmation of the content of the medicine advertisement, is responsible for the content of the medicine advertisement.

Article 108. Procedures for receiving, appraising and confirming the content of medicine advertisements

1. The establishment requesting confirmation of the content of a medicine advertisement submits the dossier directly, via postal services, or online to the Ministry of Health.

2. Within 15 days from the date of receiving a complete dossier, the Ministry of Health organises appraisal under this Decree and the law on advertising and issues a confirmation certificate using Form No. 03 or Form No. 04 in Appendix VI issued with this Decree. Where no confirmation certificate is issued, the Ministry of Health must reply in writing, clearly stating the reasons for not issuing it.

3. Where amendment or supplementation of the dossier is required, within 15 days from the date of receiving a complete dossier, the Ministry of Health issues a document requesting the establishment to amend or supplement it and acts as follows:

a) The document requesting amendment or supplementation must specifically and in detail state the documents and contents to be amended or supplemented, together with the reasons;

b) Within 15 days from the date of receiving the amended or supplemented dossier as requested, the Ministry of Health organises appraisal under this Decree and the law on advertising and issues a confirmation certificate using Form No. 03 or Form No. 04 in Appendix VI issued with this Decree, or replies in writing that no confirmation certificate is issued, clearly stating the reasons;

c) Within 90 days from the date the Ministry of Health issues the written notice of amendment or supplementation, the establishment must submit the amended or supplemented dossier as required. After that period, the submitted dossier is no longer valid.

4. While handling the submitted dossier, the Ministry of Health will suspend confirmation and issue a written notice of the reasons when it finds that the safety and efficacy information in the medicine's package leaflet is not yet appropriate, has not updated information required by the competent State management agency, or does not conform to documents and professional guidelines relating to medicines issued or recognised by the Ministry of Health. The suspension of confirmation lasts until the establishment resubmits the updated and amended medicine advertisement content to ensure the safety of medicine users.

5. Three working days before advertising a medicine through organising a seminar, conference or event, the establishment that has been issued a certificate confirming the content of the medicine advertisement must issue a written notice to the provincial People's Committee of the locality where the medicine advertising is held, stating the time and place, accompanied by a copy of the approved certificate confirming the content of the medicine advertisement.

Where there is a change to the place or time of the confirmed medicine advertising, the establishment must notify the People's Committee of the province of the locality where it is held at least 01 working day before carrying out the medicine advertising.

6. Receipt of new dossiers and handling of submitted dossiers are suspended for an establishment requesting confirmation of the content of medicine advertisements, including authorised establishments specified at Points b and c, Clause 7, Article 107 of this Decree, when it commits one of the following violations:

a) Altering or forging legal papers of the competent State management agency in the dossier requesting confirmation of the content of the medicine advertisement;

b) Advertising a medicine before the content has been confirmed by the competent State agency, or not in accordance with the confirmed content;

c) Using certifications not recognised by the Ministry of Health, using material benefits, exploiting the name of organisations or individuals, or using symbols, images, positions, prestige, letters or thank-you letters to provide information on or advertise medicines;

d) Using clinical research results, preclinical research results, test results or bioequivalence test results not recognised by the Ministry of Health to provide information on or advertise medicines.

7. The period of suspending receipt of dossiers requesting confirmation of the content of medicine advertisements, from the date the competent State agency issues the notice of the violation, is as follows:

a) From 01 year to 02 years, for the case specified at Point a, Clause 6 of this Article;

b) From 06 months to 12 months, for the cases specified at Point b, c or d, Clause 6 of this Article;

8. Within 03 working days from the date of issuing the certificate confirming the content of the medicine advertisement, the Ministry of Health publishes the confirmed medicine advertisement content on the web portal of the Ministry of Health.

Article 109. Provisions on correction and adjustment of the content of medicine advertisements already issued a confirmation certificate

1. Where the information stated on the certificate confirming the content of a medicine advertisement was written incorrectly under Clause 3, Article 105 of this Decree, the establishment named in the request for confirmation of the content of the medicine advertisement sends a written notice to the agency issuing the certificate, clearly stating the incorrectly written contents to be corrected. Upon receiving the written notice, the agency issuing the certificate gives the establishment a Receipt Slip for the notice of the medicine advertisement content to be corrected, using Form No. 05 in Appendix VI issued with this Decree. The establishment may carry out medicine advertising according to the content it has corrected and is responsible for the corrected content.

2. Where the content of a medicine advertisement already issued a confirmation certificate changes in the manner specified in Clause 2, Article 105 of this Decree, the establishment named in the request for confirmation of the content of the medicine advertisement sends a written notice to the agency issuing the certificate of the adjusted content. The establishment may make the adjustment automatically and is responsible for the adjusted content of the medicine advertisement.

Article 110. Validity of certificates confirming the content of medicine advertisements

1. A certificate confirming the content of a medicine advertisement does not state a validity period and expires in the following cases:

a) The medicine's marketing authorisation expires;

b) The medicine's marketing authorisation is revoked;

c) A change of information leads to the case requiring issuance of a certificate confirming the content of the medicine advertisement specified at Point b, Clause 1, Article 105 of this Decree;

d) The pharmaceutical State management agency recommends restricting use or use under the supervision of a medical examination and treatment practitioner;

dd) A medicine containing an active ingredient or medicinal herb removed from the list of non-prescription medicines announced by the Minister of Health.

2. Where the marketing authorisation of a medicine expires but continues to be used under Point c, Clause 8, Article 56 of the Law on Pharmacy or is renewed, the certificate confirming the content of the medicine advertisement is automatically extended for exactly the period of continued use or renewal of the medicine's marketing authorisation, if it does not fall within the cases of expiry specified in Clause 1 of this Article.

Article 111. Responsibilities of organisations and individuals conducting and participating in medicine advertising

1. Responsibilities of the medicine advertiser:

a) Perform the obligations specified in the Law on Advertising;

b) Ensure that the content of the medicine advertisement meets the provisions of law on medicine advertising;

c) Be responsible before law for the content of the medicine advertisement, including in the case of authorising medicine advertising;

d) Provide only medicine advertisement content already confirmed by the competent authority to the medicine advertisement publisher and the person providing advertising services;

dd) Perform other responsibilities under law.

2. Responsibilities of the person providing medicine advertising services:

a) Perform the obligations specified in the Law on Advertising;

b) Provide documents relating to the content of the medicine advertisement when requested by the competent authority;

c) Provide medicine advertising services only for medicine advertisement content already confirmed by the competent authority;

d) Bear joint responsibility where the content of the medicine advertisement fails to meet the provisions of law on medicine advertising;

dd) Perform other responsibilities under law.

3. Responsibilities of the medicine advertisement publisher:

a) Perform the responsibilities specified at Points b, c, d and dd, Clause 2 of this Article and the obligations specified in the Law on Advertising;

b) Must not publish medicine advertisement content accompanied by information on pathology, treatment measures or health communication that could lead to an understanding that this information is the cause, consequence or result of using or not using that medicine;

c) Perform other responsibilities under law.

Chapter VIII

MEDICINE PRICE MANAGEMENT MEASURES

Section 1. DECLARATION AND RE-DECLARATION OF EXPECTED WHOLESALE PRICES OF PRESCRIPTION MEDICINES, AND RECOMMENDATIONS ON DECLARED AND RE-DECLARED EXPECTED WHOLESALE PRICE LEVELS

Article 112. Provisions on the Declaration Table for declaring and re-declaring expected wholesale prices of medicines

1. The Declaration Table of expected wholesale prices of medicines imported into Vietnam and domestically produced medicines uses Form No. 01 in Appendix VII issued with this Decree.

2. The Re-declaration Table of expected wholesale prices of medicines imported into Vietnam and domestically produced medicines uses Form No. 02 in Appendix VII issued with this Decree.

Article 113. Subjects required to declare and re-declare expected wholesale prices of medicines

1. Domestic medicine manufacturing establishments declare and re-declare the expected wholesale prices of domestically produced prescription medicines.

Where a domestically produced medicine is a medicine contract-manufactured in Vietnam, the subject declaring and re-declaring the expected wholesale price of the medicine is the medicine manufacturing establishment or the establishment commissioning the contract manufacturing.

2. Medicine importing establishments declare and re-declare the expected wholesale prices of prescription medicines imported into Vietnam.

Article 114. Order and procedures for receiving declarations and re-declarations of expected wholesale prices of medicines

1. After being granted a marketing authorisation or an import licence for a medicine, the subject required to declare under Article 113 of this Decree declares the expected wholesale price of the medicine before wholesaling the establishment's first lot of the medicine onto the Vietnamese market. For subsequent production lots or subsequent import shipments, the establishment need not declare if there is no price adjustment compared with the expected wholesale price of the medicine that the establishment itself has declared.

2. When there is a need to change the expected wholesale price of medicines already declared or the immediately preceding re-declaration published on the web portal of the Ministry of Health, the subject required to declare under Article 113 of this Decree re-declares.

3. When declaring or re-declaring, the subject required to declare under Article 113 of this Decree submits the Declaration or Re-declaration Table of expected wholesale prices of medicines, in the form specified in Article 112 of this Decree, directly, via postal services, or online to the Ministry of Health.

4. The Ministry of Health organises receipt of the Declaration or Re-declaration Table of expected wholesale prices of medicines. Where the Declaration or Re-declaration Table is in the prescribed form, contains full information, and the declaring subject has completed payment of fees as prescribed, within 01 working day the Ministry of Health returns a Receipt Slip using Form No. 03 in Appendix VII issued with this Decree. Where the Declaration or Re-declaration Table is not in the prescribed form or lacks complete information, within 01 working day the Ministry of Health returns the Declaration Table to the submitting declaring subject, clearly stating the reasons for return.

5. Within 07 working days from the date of receiving a complete dossier, the Ministry of Health reviews the medicine information in the Declaration or Re-declaration Table of expected wholesale prices on the basis of the medicine's marketing authorisation or import licence and publicly posts the declared or re-declared expected wholesale prices of medicines on the web portal of the Ministry of Health. Where the declared or re-declared expected wholesale prices are not publicly posted, the Ministry of Health replies in writing, clearly stating the reasons.

6. The subject declaring or re-declaring expected wholesale prices of medicines is responsible for fully complying with the provisions on declaring and re-declaring expected wholesale prices of medicines under the Law on Pharmacy and this Decree; is fully responsible before law for the accuracy and truthfulness of the information in the Declaration or Re-declaration Table of expected wholesale prices of medicines; complies with reporting on the declared or re-declared expected wholesale price levels of medicines as requested by the State management agency for medicine prices to serve price stabilisation, State management of prices, inspection and examination; and complies with inspection and examination by the competent State agency (if any).

Article 115. Medicines exempt from declaring expected wholesale prices

Domestically produced prescription medicines, or prescription medicines imported for non-commercial purposes, are exempt from declaring expected wholesale prices when they fall within one of the following cases:

1. Medicines and vaccines used free of charge for the people to meet urgent needs for national defence and security, remedying the consequences of incidents, natural disasters and catastrophes, and epidemic prevention and control.

2. Medicines serving State health programmes.

3. Aid and humanitarian aid medicines.

4. Medicines for clinical trials; bioequivalence testing and bioavailability assessment; as registration samples, testing samples or for scientific research; or for display at exhibitions and fairs.

5. Medicines meeting the criteria specified in Clause 1, Article 60 of this Decree.

Article 116. Recommendations on declared and re-declared expected wholesale price levels of medicines where the expected wholesale price of a medicine is higher than the highest price of a similar medicine product that has been declared or re-declared and the Ministry of Health has not yet made a recommendation

1. Where a medicine's declared or re-declared expected wholesale price relates to the same concentration or content as a similar declared or re-declared medicine product, the Ministry of Health makes a recommendation in one of the following cases:

a) The declared or re-declared expected wholesale price is higher than the highest declared or re-declared expected wholesale price of a similar medicine product manufactured on a medicine production line meeting equivalent Good Manufacturing Practice principles and standards;

b) The declared or re-declared expected wholesale price of a medicine manufactured in a country whose pharmaceutical regulatory authority is a stringent regulatory authority is higher than the declared or re-declared expected wholesale price of the reference brand-name medicine or reference biological;

c) The declared or re-declared expected wholesale price of a medicine manufactured in a country whose pharmaceutical regulatory authority is not a stringent regulatory authority is higher than the declared or re-declared expected wholesale price of medicines manufactured in countries with stringent regulatory authorities, or higher than the declared or re-declared expected wholesale price of the reference brand-name medicine or reference biological;

d) The declared or re-declared expected wholesale price of a domestically produced medicine on a medicine production line meeting the World Health Organization's Good Manufacturing Practice principles and standards is higher than the declared or re-declared expected wholesale price of a domestically produced medicine on a medicine production line meeting the European Union's Good Manufacturing Practice principles and standards or equivalent.

2. Where a medicine's declared or re-declared expected wholesale price relates to a different concentration or content from a similar declared medicine product, the Ministry of Health makes a recommendation in one of the following cases:

a) The declared or re-declared expected wholesale price is higher than the declared or re-declared expected wholesale price of a similar medicine of the same manufacturer with a higher content or concentration;

b) The declared or re-declared expected wholesale price is higher than the declared or re-declared expected wholesale price of a similar medicine of the same content or concentration and the same manufacturer with a larger-volume packaging specification.

Article 117. Recommendations on declared and re-declared expected wholesale price levels of medicines where the difference between the declared or re-declared expected wholesale price and the winning bid price of that same medicine product exceeds the prescribed maximum difference

1. The difference of the expected wholesale price of a medicine compared with the winning bid price of that same medicine product (hereinafter referred to as the difference) is the percentage (%) between the amount of difference of the declared or re-declared expected wholesale price compared with the highest winning bid price within 12 months from the time of the recommendation, and the declared or re-declared expected wholesale price. The difference is calculated by the following formula:

2. The Ministry of Health makes a recommendation when the difference of the declared or re-declared expected wholesale price compared with the winning bid price of that same medicine product is higher than the following maximum difference:

a) 35% for medicines whose declared or re-declared expected wholesale price per smallest packaging unit is less than VND 1,000,000 (one million);

b) 15% for medicines whose declared or re-declared expected wholesale price per smallest packaging unit is greater than or equal to VND 1,000,000 (one million).

Article 118. Recommendations on declared and re-declared expected wholesale price levels of medicines where there is no similar medicine product in circulation in Vietnam for the medicine whose expected wholesale price is declared or re-declared, and the declared or re-declared price is higher than the selling price in the country of origin or other countries

The Ministry of Health makes a recommendation for a medicine whose declared or re-declared expected wholesale price has no similar medicine product in circulation in Vietnam when it finds that the declared or re-declared expected wholesale price is higher than the selling price in the country of origin or another country obtained in the following cases:

1. The declared or re-declared expected wholesale price is higher than the price information in the country of origin or another country provided by the declaring subject in the Declaration Table of expected wholesale prices of medicines.

2. The declared or re-declared expected wholesale price is higher than the price information in the country of origin or another country provided by a Vietnamese or foreign State agency.

3. The declared or re-declared expected wholesale price is higher than the price information found on the websites of medicine price management agencies, health insurance agencies, and medicine procurement agencies of countries, provided by a Vietnamese or foreign State agency.

Article 119. Order of making recommendations on declared and re-declared expected wholesale price levels of medicines

1. During the circulation of a medicine, when it finds that the declared or re-declared expected wholesale price falls within one of the cases specified in Articles 116, 117 and 118 of this Decree, the Ministry of Health issues a written recommendation on the declared or re-declared expected wholesale price of the medicine. The written recommendation is sent to the declaring or re-declaring subject and publicly posted on the web portal of the Ministry of Health.

2. After the Ministry of Health publicly posts the written recommendation, the subject declaring or re-declaring the expected wholesale price of the medicine is responsible for reporting and explaining the recommended contents. In the case of a price reduction compared with the declared or re-declared expected wholesale price according to the recommended content, the declaring or re-declaring subject re-declares the expected wholesale price of the medicine under Article 114 of this Decree.

3. Where the declaring or re-declaring subject reports and explains the contents recommended by the Ministry of Health, after considering the appropriateness of fluctuations in price-forming factors, or the appropriateness of the difference between the expected wholesale price of the medicine and the updated winning bid price of the medicine provided by the declaring or re-declaring subject, or the conformity with information on the selling price of the medicine in the country of origin or other countries provided by the declaring or re-declaring subject, the Ministry of Health withdraws the publicly posted written recommendation or publicly posts the Ministry of Health's feedback on the written report and explanation of the declaring or re-declaring subject.

In the course of considering the report, explanation and proving documents of the declaring or re-declaring subject, the Ministry of Health coordinates with relevant agencies and organisations to consider the explanation of the declaring or re-declaring subject where it deems necessary.

Section 2. PROVISIONS ON RETAIL MARKUP AT MEDICINE RETAIL ESTABLISHMENTS WITHIN THE PREMISES OF MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS, AND POLICIES ON PRICE MAINTENANCE AND PRICE REDUCTION FOR NEW MEDICINES, REFERENCE BRAND-NAME MEDICINES, HIGH-TECHNOLOGY MEDICINES, VACCINES AND RARE MEDICINES WITH PRODUCTION TECHNOLOGY TRANSFERRED IN VIETNAM

Article 120. Provisions on retail markup and retail prices of medicines of medicine retail establishments within the premises of medical examination and treatment establishments

1. Retail markup is the amount of difference between the selling price and the purchase price of medicines of a medicine retail establishment within the premises of a medical examination and treatment establishment, calculated by the formula:

Retail markup = Medicine selling price - Medicine purchase price

2. The retail markup rate is the percentage (%) between the retail markup and the medicine purchase price of a medicine retail establishment within the premises of a medical examination and treatment establishment, calculated by the formula:

3. The retail price of medicines at a medicine retail establishment within the premises of a medical examination and treatment establishment is calculated by the following formula:

Medicine retail price = Medicine purchase price x (1 + Retail markup rate)

4. The retail markup rate of medicine retail establishments within the premises of medical examination and treatment establishments must not exceed the following maximum retail markup rates:

a) For medicines with a purchase price per smallest packaging unit of less than or equal to VND 1,000 (one thousand), the maximum retail markup rate is 15%;

b) For medicines with a purchase price per smallest packaging unit of over VND 1,000 (one thousand) up to VND 5,000 (five thousand), the maximum retail markup rate is 10%;

c) For medicines with a purchase price per smallest packaging unit of over VND 5,000 (five thousand) up to VND 100,000 (one hundred thousand), the maximum retail markup rate is 7%;

d) For medicines with a purchase price per smallest packaging unit of over VND 100,000 (one hundred thousand) up to VND 1,000,000 (one million), the maximum retail markup rate is 5%;

dd) For medicines with a purchase price per smallest packaging unit of over VND 1,000,000 (one million), the maximum retail markup rate is 2.5%.

Article 121. Application of price maintenance and price reduction policies for new medicines, reference brand-name medicines, high-technology medicines, vaccines and rare medicines with production technology transferred in Vietnam

1. New medicines, reference brand-name medicines, high-technology medicines, vaccines and rare medicines with production technology transferred in Vietnam are subject to price maintenance and price reduction policies in the price negotiation plan for bidding packages applying the price negotiation form when they meet one of the following provisions:

a) The medicine manufactured in Vietnam has been granted a marketing authorisation in the form of technology transfer, or is a contract-manufactured medicine with technology transfer;

b) The medicine manufactured overseas has been granted a Technology Transfer Registration Certificate under the law on technology transfer, and has begun producing a trial lot on the technology transfer production line in Vietnam to prepare the dossier requesting a marketing authorisation for a technology-transferred medicine or a contract-manufactured medicine with technology transfer.

2. Principles of applying price maintenance and price reduction policies:

a) A reference brand-name medicine that has no, or fewer than 03, valid marketing authorisations at the time of preparing the price negotiation plan for medicines of the same active ingredient, concentration, content and dosage form manufactured in countries with stringent regulatory authorities has its price maintained at the winning bid result or price negotiation result of the medicine being supplied to medical examination and treatment establishments when preparing the price negotiation plan;

b) A new medicine, high-technology medicine, vaccine or rare medicine that has no, or fewer than 03, valid marketing authorisations at the time of preparing the price negotiation plan for medicines of the same active ingredient, concentration, content and dosage form has its price maintained at the winning bid result or price negotiation result of the medicine being supplied to medical examination and treatment establishments when preparing the price negotiation plan;

c) A medicine not subject to the price maintenance policy under Points a and b of this Clause is subject to a price reduction of at most 50% of the price reduction rate under the price negotiation plan where there is no technology transfer.

3. Duration of applying price maintenance and price reduction policies:

a) A medicine meeting Point a, Clause 1 of this Article is subject to the price maintenance or price reduction policy 01 time from the date of being granted a marketing authorisation;

b) A medicine meeting Point a, Clause 1 of this Article that has completed the transfer of all production stages in Vietnam is subject to the price maintenance or price reduction policy 01 additional time in the next price negotiation;

c) A medicine meeting Point b, Clause 1 of this Article is subject to the price maintenance or price reduction policy 01 time from the date of beginning production of the trial lot on the technology transfer production line in Vietnam. The beginning of trial lot production is proved by the trial production lot records of the establishment receiving the technology transfer or the establishment undertaking contract manufacture of medicines with technology transfer.

Chapter IX

IMPLEMENTATION PROVISIONS

Article 122. Roadmap for implementing Good Practice for State medicine and medicinal ingredient testing establishments

1. From the date this Decree takes effect, State medicine and medicinal ingredient testing establishments that have not fully complied with Good Laboratory Practice may carry out only tests within the scope of certification meeting the standard TCVN ISO/IEC 17025 on general requirements for the competence of testing and calibration laboratories, assessed and certified by conformity assessment organisations. By 01 January 2027 at the latest, State medicine and medicinal ingredient testing establishments must fully comply with Good Laboratory Practice.

2. From the date this Decree takes effect, State medicine and medicinal ingredient testing establishments that begin medicine and medicinal ingredient testing activities for the first time, or add to the scope of testing activities, must comply with Good Laboratory Practice.

Article 123. Roadmap for exercising competence to issue export and import licences for medicines and medicinal ingredients

1. Before 01 July 2027, the Ministry of Health:

a) Issues import licences for medicines, active pharmaceutical ingredients, medicinal herbs, semi-finished medicine products, semi-finished medicinal herb products, excipients and capsule shells specified in Articles 57, 58, 59, 65, 68, 70 and 72 of this Decree;

b) Issues export licences for medicines, medicinal ingredients, and medicinal herbs on the list of controlled precious, rare and endemic medicinal herb species and varieties specified in Article 43; Article 44; Article 45; Points b and c, Clause 1, Article 46; Clause 1, Article 47; Article 48 and Clause 5, Article 82 of this Decree;

2. From 01 July 2027, the provincial People's Committee of the locality where the establishment has its head office issues export and import licences for medicines, active pharmaceutical ingredients, medicinal herbs, semi-finished medicine products, semi-finished medicinal herb products, excipients and capsule shells for the cases specified in Clause 1 of this Article.

Import licences and export licences issued by provincial People's Committees are valid nationwide.

Article 124. Roadmap for receiving reports and the form of reporting on export, import, issue, receipt, stock and use of medicines and medicinal ingredients

1. Before 01 July 2027, the Ministry of Health receives reports of medicine and medicinal ingredient manufacturing, exporting and importing establishments specified in Clause 1, Article 35 and Clause 2, Article 81 of this Decree.

2. From 01 July 2027, reporting cases under Clause 1, Article 35 and Clause 2, Article 81 of this Decree are carried out as follows:

a) Provincial People's Committees receive reports for import and export of medicines and medicinal ingredients specified in Article 43; Article 44; Points b and c, Clause 1, Article 46; Clause 1, Article 47 and Articles 48, 57, 58, 59 and 65 of this Decree;

b) The Ministry of Health receives reports for import of medicines and medicinal ingredients, except the cases specified at Point a of this Clause.

Article 125. Roadmap for implementing import control of medicines already having a marketing authorisation in Vietnam

1. The activities specified in Article 87 of this Decree are carried out from 01 July 2028.

2. The Ministry of Finance coordinates with the Ministry of Health in developing an online tool integrated on the National Single Window Portal to ensure implementation of Clause 1 of this Article.

Article 126. Roadmap for declaring expected wholesale prices of prescription medicines

Within 30 days from the date this Decree takes effect, for prescription medicines whose first lot has been wholesaled onto the market but whose expected wholesale price has not been publicly posted on the web portal of the Ministry of Health, or prescription medicines whose expected wholesale price has changed from the immediately preceding declared or re-declared expected wholesale price publicly posted on the web portal of the Ministry of Health before 01 July 2024, the subject required to declare expected wholesale prices of medicines is responsible for declaring or re-declaring under Section 1, Chapter VIII of this Decree.

Article 127. Transitional articles and clauses

1. Dossiers for administrative procedures under the Law on Pharmacy No. 105/2016/QH13 and relevant guiding documents submitted before the effective date of this Decree continue to be handled under the Law on Pharmacy No. 105/2016/QH13 and relevant guiding documents, except where the establishment requests to follow Law No. 44/2024/QH15 amending and supplementing a number of articles of the Law on Pharmacy No. 105/2016/QH13 or the provisions of this Decree.

2. Export and import licences for medicines and medicinal ingredients, export and import Orders for medicines and medicinal ingredients, and related administrative procedures follow Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Decree No. 88/2023/ND-CP and relevant documents until the licence expires.

Medicines and medicinal ingredients exported or imported under the Licences and Orders specified in this Clause are cleared through customs if they meet the provisions of Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Decree No. 88/2023/ND-CP and relevant documents, or the provisions of this Decree, whichever is more convenient for enterprises, organisations and individuals.

For medicines used in clinical trial research that are not specially controlled medicines, where the medicine import licence has expired or where the import licence is still valid but the information on the medicine has been updated in the Ministry of Health's Table of information on imported medicines used for clinical trials, the importing establishment carries out the import according to the information announced by the Ministry of Health.

3. Medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields granted a marketing authorisation in Vietnam, and medicinal ingredients on the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields announced for producing medicines under a drug registration dossier already having a marketing authorisation in Vietnam, shipped from the port of departure of the exporting country before the date the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields takes effect, are imported under the list of medicines and active pharmaceutical ingredients on the list of substances prohibited from use in certain sectors and fields in the guiding document in effect at the time the goods were shipped from the port of departure of the exporting country.

4. Certificates confirming the content of medicine information and certificates confirming the content of medicine advertisements issued before the effective date of this Decree continue to be used until they expire.

5. By 01 July 2026 at the latest, the Ministry of Public Security is responsible for sharing criminal record data of persons requesting a Pharmacy Practising Certificate with the agency issuing Pharmacy Practising Certificates, at the request of that agency. The shared data includes information on the Criminal Record Certificate under the Law on Criminal Records.

6. For prescription medicines that already have declared or re-declared prices under Clause 3, Article 107 of the Law on Pharmacy No. 105/2016/QH13, where the declared or re-declared price is not changed, the importing establishment or manufacturing establishment need not make a declaration, and the declared price continues to be used and is regarded as the declared or re-declared expected wholesale price of the medicine.

Article 128. Amendments and supplements to Decree No. 31/2021/ND-CP dated 26 March 2021 of the Government detailing and guiding the implementation of a number of articles of the Law on Investment

Add Clause 11 after Clause 10, Section IV, Part A. Especially investment-incentivised sectors and trades, of Appendix II List of investment-incentivised sectors and trades issued with Decree No. 31/2021/ND-CP dated 26 March 2021 of the Government, as follows:

“11. Technology research and development, production or technology transfer to produce herbal medicines and traditional medicines from domestic medicinal herb sources, active pharmaceutical ingredients, new medicines, reference brand-name medicines, rare medicines, the first domestically produced generic medicines, high-technology medicines, vaccines and biologicals; cultivation of medicinal herbs in areas with difficult socio-economic conditions or areas with especially difficult socio-economic conditions; research to conserve and develop the genetic resources of precious, rare and endemic domestic medicinal herbs; creation of new varieties from genetic resources of medicinal herbs with high economic value, having a newly established investment project (including expansion of that newly established project) meeting Clause 2, Article 8 of the Law on Pharmacy”.

Article 129. Effect

1. This Decree takes effect from 01 July 2025.

2. From the date this Decree takes effect, the following Decrees of the Government and provisions cease to be effective:

a) Clause 10, Article 27 of Decree No. 85/2024/ND-CP dated 10 July 2024 of the Government detailing a number of articles of the Law on Prices;

b) Decree No. 54/2017/ND-CP dated 08 May 2017 of the Government detailing a number of articles and measures for implementing the Law on Pharmacy;

c) Chapter II and Clause 4, Article 21 of Decree No. 155/2018/ND-CP dated 12 November 2018 of the Government amending and supplementing a number of provisions relating to investment and business conditions within the State management scope of the Ministry of Health;

d) Decree No. 88/2023/ND-CP dated 11 December 2023 of the Government amending and supplementing a number of articles of Decree No. 54/2017/ND-CP dated 08 May 2017 of the Government detailing a number of articles and measures for implementing the Law on Pharmacy and Decree No. 155/2018/ND-CP dated 12 November 2018 of the Government amending and supplementing a number of provisions relating to investment and business conditions within the State management scope of the Ministry of Health;

dd) Article 3 of Decree No. 181/2013/ND-CP dated 14 November 2013 of the Government detailing the implementation of a number of articles of the Law on Advertising.

3. Where legal documents and provisions cited in this Decree are amended, supplemented or replaced, the new legal documents apply.

Article 130. Responsibility for organising implementation

1. The Minister of Health is responsible for guiding and organising the implementation of this Decree.

2. Chairpersons of provincial People's Committees organise the receipt of medicine price declarations under the Law on Prices and documents guiding the Law on Prices; and adopt incentive and support policies for developing the medicine supply system and mobile medicine retail establishments in ethnic minority areas, mountainous areas, islands, areas with difficult socio-economic conditions, and areas with especially difficult socio-economic conditions.

3. By 01 July 2027 at the latest, the Ministry of Health deploys the nationwide software system and data for online management of the export and import of medicines and medicinal ingredients.

4. Periodically before 15 January and before 15 July each year, the Ministry of Finance is responsible for sharing information with the Ministry of Health on data on specially controlled medicines cleared through customs for export and import, or sharing information on data on specially controlled medicines cleared through customs for export and import upon a written request from the Ministry of Health within 20 days from the date of receiving the Ministry of Health's written request, to serve management work.

5. Organisations and individuals, when carrying out administrative procedures in the electronic environment, are responsible for complying with the following provisions:

a) Documents required to be submitted as originals or certified copies in the administrative procedures specified in this Decree must be electronic scans with full and accurate content identical to the content of the paper original;

b) They must comply with the provisions on carrying out administrative procedures in the electronic environment under Decree No. 45/2020/ND-CP dated 08 April 2020 of the Government on carrying out administrative procedures in the electronic environment.

c) They must keep the original or a certified copy together with the entire submitted dossier for post-inspection work and are responsible for the accuracy and legality of the submitted dossier.

6. Ministers, Heads of ministerial-level agencies, Heads of Government-attached agencies, Chairpersons of People's Committees of provinces and centrally run cities, and other relevant organisations and individuals are responsible for implementing this Decree./.