Circular 28/2025/TT-BYT Good Manufacturing Practices for medicinal products and medicinal materials

CIRCULAR

Prescribing Good Manufacturing Practices for medicinal products and medicinal materials

Pursuant to the 2016 Law on Pharmacy and the 2024 Law Amending and Supplementing a Number of Articles of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 42/2025/ND-CP dated February 27, 2025 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to Decree No. 163/2025/ND-CP dated June 29, 2025, of the Government detailing a number of articles and measures for the implementation of the Law on Pharmacy;

At the proposal of the Director of the Drug Administration of Vietnam, the Director of the Agency of Traditional Medicine Administration;

The Minister of Health hereby promulgates the Circular prescribing Good Manufacturing Practices for medicinal products and medicinal materials.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular prescribes the announcement of application, promulgation of principles and standards of Good Manufacturing Practices for medicinal products and medicinal materials, and the assessment and maintenance assessment of compliance with Good Manufacturing Practices for medicinal products and medicinal materials.

Article 2. Interpretation of terms

In this Circular, the terms below are construed as follows:

1. Good Manufacturing Practices for medicinal products and medicinal materials (hereinafter referred to as Good Manufacturing Practices) mean a set of principles and standards for the manufacture of medicinal products and medicinal materials to ensure that they are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization for the medicinal product or medicinal material.

2. Manufacturer (including manufacturers of chemical medicinal products, herbal medicinal products, vaccines, biologicals, traditional medicinal products, traditional medicinal ingredients, medicinal materials, herbal medicinal materials) means a pharmaceutical business, whether or not subject to the issuance of a Certificate of Eligibility for Pharmaceutical Business, which carries out one, some, or all of the stages of the manufacturing process of medicinal products or medicinal materials.

3. Deficiency means a deviation from the principles and standards of Good Manufacturing Practices (GMP) or from applicable law regulations on pharmaceutical administration.

4. GMP stands for “Good Manufacturing Practices”.

5. WHO stands for “World Health Organization”.

6. WHO-GMP stands for “World Health Organization's Good Manufacturing Practices”.

7. PIC/S stands for “Pharmaceutical Inspection Co-operation Scheme”.

8. PIC/S-GMP stands for “Good Manufacturing Practices of the Pharmaceutical Inspection Co-operation Scheme”.

9. EU stands for “European Union”.

10. EU-GMP stands for “Good Manufacturing Practices of the European Union”.

11. US stands for “United States”.

12. SRA stands for “Stringent Regulatory Authorities” as defined by WHO.

13. EU-GMP equivalent means GMP principles and standards promulgated by the SRAs.

Chapter II

PUBLIC ANNOUNCEMENT OF APPLICATION AND PROMULGATION OF GOOD MANUFACTURING PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 3. Documents on Good Manufacturing Practices principles and standards

1. To publicly announce the application of the following Good Manufacturing Practices principles and standards:

a) WHO Good Manufacturing Practices principles and standards as prescribed in Annex I to this Circular and updated documents as prescribed in Clause 4 of this Article;

b) WHO Good Manufacturing Practices principles and standards for biological medicinal products derived from human blood and plasma as prescribed in Annex II to this Circular and updated documents as prescribed in Clause 4 of this Article;

c) Good Manufacturing Practices principles and standards of the Pharmaceutical Inspection Co-operation Scheme as prescribed in Annex III to this Circular and updated documents as prescribed in Clause 4 of this Article;

d) Good Manufacturing Practices principles and standards of the European Union as prescribed in Annex IV to this Circular and updated documents as prescribed in Clause 4 of this Article.

2. To issue the following Good Manufacturing Practices principles and standards:

a) Good Manufacturing Practices principles and standards for herbal medicinal products as prescribed in Annex V to this Circular;

b) Good Manufacturing Practices principles and standards for traditional medicinal products as prescribed in Annex VI to this Circular;

c) Good Manufacturing Practices principles and standards for traditional medicinal ingredients as prescribed in Annex VII to this Circular.

3. Application of other GMP principles and standards:

a) For manufacturers of medicinal products and medicinal materials other than excipients:

In addition to the GMP principles and standards prescribed in Clause 1 and Clause 2 of this Article, other applicable GMP principles and standards include:

- GMP principles and standards equivalent to EU-GMP principles and standards promulgated by the SRAs are applicable. Manufacturers of medicinal products and medicinal materials that implement these standards are responsible for providing the English versions promulgated by the SRAs to the Drug Administration of Vietnam for posting on the electronic portal of the Ministry of Health and the website of the Drug Administration of Vietnam;

- GMP principles and standards that have been assessed and recognized by the Ministry of Health for conformity with the GMP principles and standards promulgated or announced for application by the Minister of Health as prescribed at Point c, Clause 1, Article 97 of Decree No. 163/2025/ND-CP dated June 29, 2025, detailing a number of articles and measures for the organization and implementation of the Law on Pharmacy (hereinafter referred to as Decree No. 163/2025/ND-CP) are used in the assessment of GMP compliance of foreign manufacturers of medicinal products and medicinal materials when registering for marketing authorization of medicinal products and medicinal materials in Vietnam.

b) For manufacturers of medicinal materials that are excipients:

In addition to the GMP principles and standards prescribed in Clause 1 of this Article, excipient manufacturers may apply other GMP principles and standards of the International Pharmaceutical Excipients Council (IPEC), The Certification Scheme for Pharmaceutical Excipients (EXCiPACT), the American National Standards Institute (ANSI), the United States Pharmacopeia (USP), or other standards for excipient manufacturing applied by regulatory authorities of other countries or international organizations related to excipients used for the manufacture of medicinal products, cosmetics, and foods.

4. Updated GMP documents:

a) In cases where WHO amends or supplements the GMP principles and standards (hereinafter referred to as updated documents) prescribed at Points a and b, Clause 1 of this Article, within 03 months from the date the updated documents are publicly announced on the WHO's electronic portal, the Drug Administration of Vietnam or the Agency of Traditional Medicine Administration, according to their assigned state management fields, shall publicly announce the updated documents for relevant parties to look up, update, and apply; and shall organize the translation and public announcement of the Vietnamese version (for reference) on the electronic portal of the Ministry of Health and the websites of the Drug Administration of Vietnam and the Agency of Traditional Medicine Administration;

b) In cases where the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or the European Union has updated documents as prescribed at Points c and d, Clause 1 of this Article, which have not yet been posted on the electronic portal of the Ministry of Health or the website of the Drug Administration of Vietnam, the manufacturer of medicinal products and medicinal materials that implements them is responsible for providing the English version to the Drug Administration of Vietnam. Within 10 days from the date of receipt, the Drug Administration of Vietnam shall post the English version on the electronic portal of the Ministry of Health and its website for relevant parties to look up, update, and apply.

Article 4. Application of Good Manufacturing Practices principles and standards

1. Manufacturers of medicinal products and medicinal materials (except for biological medicinal products and medicinal materials derived from human blood and plasma) shall implement GMP as prescribed in Annex I, Annex III, or Annex IV to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.

2. Manufacturers of biological medicinal products and medicinal materials derived from human blood and plasma shall implement GMP as prescribed in Annex II to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.

3. Manufacturers of herbal medicinal products and medicinal materials from herbal medicinal materials shall implement the GMP principles and standards prescribed in Annex V to this Circular.

4. Manufacturers of traditional medicinal products that only produce traditional medicinal products in the dosage forms of extracts, pills, pellets, powders, medicated wines, and tinctures shall implement the GMP principles and standards prescribed in Part I - Annex VI to this Circular.

5. Manufacturers of traditional medicinal products in modern dosage forms (capsules, tablets, granules, oral solutions, and other modern dosage forms) not falling under the case prescribed in Clause 4 of this Article shall implement GMP as prescribed in Part II - Annex VI to this Circular.

6. Manufacturers of traditional medicinal ingredients shall implement GMP as prescribed in Annex VII to this Circular.

7. Manufacturers of medicinal products and medicinal materials may implement other GMP principles and standards equivalent to EU-GMP principles and standards, promulgated by the SRAs and the updated documents as prescribed in Clause 4, Article 3 of this Circular.

8. Manufacturers of herbal medicinal products, traditional medicinal products, and traditional medicinal ingredients may implement the GMP principles and standards prescribed in Annex I, Annex III, or Annex IV to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.

9. Manufacturers of traditional medicinal products and traditional medicinal ingredients are permitted to implement the GMP principles and standards prescribed in Part II of Annex VI, or Annex I, Annex III, Annex IV, or Annex V to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.

10. The application of GMP principles and standards for high-risk medicinal products shall be specifically regulated as follows:

a) Medicinal products and medicinal materials containing beta-lactam antibiotics (Penicillins, Cephalosporins, Penems, and the like), cytotoxic medicinal products, medicinal products containing sexual hormones of the contraceptive group, vaccines, biologicals containing live microorganisms, and specific medicinal products with separate manufacturing requirements as prescribed in GMP principles and standards (WHO-GMP, PIC/S-GMP, EU-GMP and EU-GMP equivalent), in addition to the requirement of being manufactured at an manufacturer implementing the corresponding GMP principles and standards as prescribed in this Article, must be manufactured on separate production lines (separate facilities, separate production equipment) and have measures to prevent dispersion and contamination of the environment and other medicinal products manufactured in the same area;

b) For anticancer medicinal products, sexual hormone medicinal products, and potent medicinal products not belonging to the groups of medicinal products prescribed at Point a of this Clause, the determination of the necessity and level of separation of facilities and/or production equipment shall be based on a risk assessment and the guidance of the European Medicines Agency (EMA) or WHO;

c) The medicinal products and medicinal materials prescribed at Points a and b of this Clause that are manufactured at foreign manufacturers as prescribed at Point b, Clause 1, Article 94 of Decree No. 163/2025/ND-CP, and are also granted marketing authorizations or Certificates of Pharmaceutical Product (CPP) by the regulatory authorities of these countries, shall be recognized as being within the scope of GMP certification without the requirement of being manufactured on separate production lines and shall be announced as being within the scope of manufacturing operations that have been assessed for the manufacturers as prescribed in Article 17 of this Circular.

11. Manufacturers of chemical medicinal products, including both prescription and over-the-counter chemical medicinal products, with production lines for soft capsules, liquid oral dosage forms, and topical dosage forms (creams, gels, ointments, and liquid topical preparations) are permitted to manufacture prescription chemical medicinal products, over-the-counter chemical medicinal products, and herbal medicinal products from standardized herbal extracts, pastes, granules, herbal powders, and essential oils on production lines with corresponding dosage forms. The manufacturer must implement the GMP principles and standards prescribed in Annex I, Annex III, or Annex IV to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.

12. Manufacturers that only manufacture over-the-counter chemical medicinal products are permitted to manufacture herbal medicinal products, traditional medicinal products, and health supplements with dosage forms corresponding to the certified dosage forms. The manufacturer must implement the GMP principles and standards prescribed in Annex I, Annex III, or Annex IV to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.

13. Manufacturers of herbal medicinal products are permitted to manufacture herbal medicinal products supplemented with purified components extracted from essential oils, essential oils, vitamins, and minerals and must implement the GMP principles and standards prescribed in Annex V to this Circular.

14. Manufacturers of traditional medicinal products are permitted to manufacture traditional medicinal products supplemented with purified components extracted from essential oils, essential oils, vitamins, and minerals and must implement the GMP principles and standards prescribed in Annex VI to this Circular.

15. Manufacturers of herbal medicinal products and traditional medicinal products are permitted to manufacture health supplements with dosage forms corresponding to the certified dosage forms and must implement the corresponding GMP principles and standards as prescribed in Clause 1, Clause 8, and Clause 9 of this Article.

16. Manufacturers of herbal medicinal materials and semi-finished herbal medicinal materials in the form of extracts, granules, powders, tinctures, essential oils, resins, gums, and jellies are permitted to manufacture raw materials and semi-finished health supplements with dosage forms corresponding to the certified dosage forms and must implement the corresponding GMP principles and standards as prescribed in Clauses 8 and 9 of this Article.

17. Manufacturers with a separate production line that only manufacture biological medicinal products or medicinal materials containing probiotics are permitted to manufacture raw materials and health supplements containing the same type of probiotics and with dosage forms corresponding to the certified dosage forms and must implement the corresponding GMP principles and standards as prescribed in Clause 1 of this Article.

18. Manufacturers that perform one or some of the stages of the manufacturing process of medicinal products or medicinal materials shall implement and comply with GMP according to the corresponding requirements suitable for the manufacturing stage of medicinal products or medicinal materials as prescribed in Clauses 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 of this Article.

19. Manufacturers of medicinal products and medicinal materials shall implement the updated GMP documents as prescribed in Clause 4, Article 3 of this Circular within the time limit of:

a) 12 months in case of required changes to facilities or production equipment, from the time the updated documents are publicly announced on the electronic portal of the Ministry of Health and the website of the Drug Administration of Vietnam;

b) 06 months in case of updates not prescribed at Point a of this Clause, from the time the updated documents are publicly announced on the electronic portal of the Ministry of Health and the website of the Drug Administration of Vietnam.

20. Manufacturers of medicinal materials that are excipients shall implement the GMP principles and standards and comply with the provisions of Part IV of Annex I to this Circular or other GMP principles and standards as prescribed in Clause 3, Article 3 of this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular. In cases where WHO, IPEC, EXCiPACT, ANSI, USP, or other international organizations related to excipients used for the manufacture of medicinal products, cosmetics, and foods have publicly announced amendments or supplements to the GMP principles and standards for medicinal materials that are excipients (hereinafter referred to as updated documents) on their respective websites, the manufacturer of medicinal materials that are excipients shall implement the updated GMP documents within the following time limits:

a) 12 months in case of required changes to facilities or production equipment, from the time the updated documents are publicly announced;

b) 06 months in case of updates not prescribed at Point a of this Clause, from the time the updated documents are publicly announced.

Chapter III

ASSESSMENT OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICES FOR THE ISSUANCE OF THE CERTIFICATE OF ELIGIBILITY FOR PHARMACEUTICAL BUSINESS FOR MANUFACTURERS OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 5. Dossier serving as the basis for assessment of compliance with Good Manufacturing Practices

1. The dossier serving as the basis for assessment of GMP compliance for a pharmaceutical business means the dossier submitted by the pharmaceutical business when applying for a Certificate of Eligibility for Pharmaceutical Business as prescribed in Clause 1, Article 38 of the Law on Pharmacy, comprising:

a) Documents as prescribed in Clause 1 and Point a, Clause 2, Article 20 of Decree No. 163/2025/ND-CP;

b) Documents as prescribed at Point a of this Clause and documents prescribed at Point a, Clause 1, Article 37 of Decree No. 163/2025/ND-CP for manufacturers of medicinal products subject to special control;

c) Technical documents on the manufacturer as prescribed at Point a, Clause 2, Article 20 of Decree No. 163/2025/ND-CP, presented in accordance with the guidance on the Site Master File of the manufacturer as prescribed in Annex VIII to this Circular, or an updated Site Master File in the case of adding to the scope of operations.

2. In cases where a manufacturer applies for a GMP Certificate together with a Certificate of Eligibility for Pharmaceutical Business, the manufacturer must clearly state this in the Application for the Certificate of Eligibility for Pharmaceutical Business.

3. In cases where a manufacturer applies for a Certificate of Eligibility for Pharmaceutical Business with the scope of manufacturing medicinal products or medicinal materials, and also sells or delivers the medicinal products or medicinal materials manufactured by the manufacturer to wholesalers, retailers, or medical examination and treatment establishments, it must provide additional technical and personnel documents in accordance with the principles of Good Distribution Practices for medicinal products and medicinal materials as prescribed at Point c, Clause 2, Article 20 of Decree No. 163/2025/ND-CP. The receiving authority shall concurrently assess compliance with Good Distribution Practices (GDP) when assessing the GMP compliance of the manufacturer in accordance with relevant law regulations on Good Distribution Practices for medicinal products and medicinal materials.

In cases where the manufacturer delivers medicinal products or medicinal materials at the warehouse of the manufacturer, it is not required to submit the aforementioned technical and personnel documents in accordance with the principles of Good Distribution Practices.

Article 6. Sequence for assessing compliance with Good Manufacturing Practices for medicinal products and medicinal materials

1. Dossier reception:

The manufacturer shall submit 01 (one) dossier as prescribed in Article 5 of this Circular, either directly, via postal service, or online, along with the validation fee as prescribed by the Minister of Finance for the validation of standards and conditions for manufacturing, to the Receiving Authority of the Ministry of Health which shall be:

a) The Agency of Traditional Medicine Administration, if the manufacturer applies for a Certificate of Eligibility for Pharmaceutical Business with the scope of only manufacturing herbal medicinal materials, traditional medicinal products, and traditional medicinal ingredients at the time of dossier submission;

b) The Drug Administration of Vietnam, if the manufacturer applies for a Certificate of Eligibility for Pharmaceutical Business with the scope of only manufacturing medicinal materials (excluding herbal medicinal materials), chemical medicinal products, herbal medicinal products, vaccines, and biologicals at the time of dossier submission;

c) The Drug Administration of Vietnam, if the manufacturer applies for a Certificate of Eligibility for Pharmaceutical Business with the scope of concurrently manufacturing one of the medicinal products or medicinal materials prescribed at Point a of this Clause and one of the medicinal products or medicinal materials prescribed at Point b of this Clause at the time of dossier submission.

2. Sequence for receiving and processing the dossier:

a) Upon receiving a complete dossier as prescribed in Clause 1, Article 5 of this Circular, the Receiving Authority shall issue the applicant a Dossier Receipt Note made using Form No. 01 in Annex I to Decree No. 163/2025/ND-CP;

b) Within 05 working days from the date of receiving a valid dossier, the Receiving Authority shall form an Assessment Team and send the manufacturer the decision to form the Assessment Team, which includes the expected time for the on-site assessment at the manufacturer;

c) Within 07 working days from the date of the formation decision, and 03 working days if the applicant is a manufacturer of medicinal products or medicinal materials prioritized for administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy, the Assessment Team shall conduct an on-site assessment at the manufacturer.

Article 7. Process for assessing compliance and classification of compliance with Good Manufacturing Practices

1. Documents used in assessing GMP compliance: WHO-GMP principles and standards documents or GMP principles and standards documents as prescribed at Points a and b, Clause 1 and Clause 2, Article 3 of this Circular corresponding to the manufacturing operations of the manufacturer.

2. On-site assessment process at the manufacturer:

a) Step 1. The Assessment Team announces the Decision to form the Assessment Team, the purpose, details, and planned assessment program at the manufacturer;

b) Step 2. The manufacturer presents a summary of its organization, personnel, and GMP implementation and application, or particulars corresponding to the details of the assessment;

c) Step 3. The Assessment Team conducts an on-site assessment of the GMP implementation at the manufacturer according to each specific details. In cases where the manufacturer performs one or some of the stages of the manufacturing process, the assessment details shall only include the requirements corresponding to the one or some manufacturing stages that the manufacturer performs. The assessment program may be adjusted according to the actual implementation situation or deficiencies of the manufacturer discovered during the assessment;

d) Step 4. The Assessment Team holds a meeting with the manufacturer to announce the deficiencies found during the assessment (if any); assesses the level of each deficiency; discusses with the manufacturer in cases where the manufacturer does not agree with the Assessment Team's evaluation of each deficiency or the level of compliance with GMP principles and standards of the manufacturer.

dd) Step 5. Draw and sign the written record of assessment:

After reaching an agreement with the manufacturer, the Assessment Team draws a written record of assessment made using Form No. 03 as prescribed in Annex X to this Circular. The written record of assessment must state the composition of the Assessment Team, the composition of the manufacturer, the location, time, scope of assessment, form of assessment, and any points of disagreement between the Assessment Team and the manufacturer (if any). The head of the manufacturer and the Head of the Assessment Team shall sign the written record of assessment. The written record shall be made into 02 copies, of which 01 is kept at the manufacturer and 01 is kept at the Receiving Authority.

e) Step 6. Finalize the GMP assessment report:

Within 5 working days from the date of signing the written record of assessment, the Assessment Team is responsible for preparing a GMP written record of assessment made using Form No. 04 as prescribed in Annex X to this Circular and sending it to the manufacturer. The GMP assessment report must list, analyze, and classify the level of deficiencies that the manufacturer needs to correct and remedy; reference the corresponding provisions of legal documents and GMP principles and standards, and assess the level of GMP compliance of the manufacturer. The classification of the level of deficiencies and the assessment of the GMP compliance level of the manufacturer (specifically for each production line) are prescribed in Annex IX to this Circular. The GMP assessment report shall be made into 02 copies, of which 01 is sent to the manufacturer and 01 is kept at the Receiving Authority.

3. Level of GMP compliance:

The level of GMP compliance of the manufacturer as prescribed in Annex IX to this Circular includes the following levels:

a) The manufacturer complies with GMP at level 1;

b) The manufacturer complies with GMP at level 2;

c) The manufacturer complies with GMP at level 3;

d) The manufacturer complies with GMP at level 4.

Article 8. Handling of assessment results of compliance with Good Manufacturing Practices

1. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 1 as prescribed at Point a, Clause 3, Article 7 of this Circular:

a) Within 07 working days from the date of finalizing the GMP assessment report, the Receiving Authority shall submit to the Minister of Health for the promulgation of a Certificate of Eligibility for Pharmaceutical Business made using Form No. 13 in Annex I to Decree No. 163/2025/ND-CP and shall issue a GMP Certificate made using Form No. 05 in Annex X to this Circular if the manufacturer requests it;

b) The scope of manufacturing operations recorded on the Certificate of Eligibility for Pharmaceutical Business of the manufacturer shall be determined for each production line that has been assessed as GMP compliant.

2. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 2 as prescribed at Point b, Clause 3, Article 7 of this Circular:

a) Within 05 working days from the date of finalizing the GMP assessment report, the Receiving Authority shall send a written notice requesting the manufacturer to correct and remedy the identified deficiencies made using Form No. 16 in Annex I to Decree No. 163/2025/ND-CP, accompanied by the GMP assessment report sent to the manufacturer;

b) After completing the correction and remedy of the deficiencies, the manufacturer must submit a written report on the correction and remedy, including a plan and supporting evidence (documents, photos, videos, certificates, or other supporting materials);

c) Within 20 days from the date of receiving the manufacturer's written report on the completion of the correction and remedy of deficiencies, the Receiving Authority shall assess the result of the correction and remedy by the manufacturer according to the documents prescribed in Clause 1, Article 7 of this Circular, prepare an assessment report on the correction and remedy of deficiencies by the manufacturer, and conclude on the GMP compliance status of the manufacturer:

- The Receiving Authority shall submit to the Minister of Health for the promulgation of a Certificate of Eligibility for Pharmaceutical Business and shall issue a GMP Certificate (in cases where the manufacturer requests it) made using Form No. 05 as prescribed in Annex X to this Circular in cases where the correction by the manufacturer has met the requirements and the manufacturer is concluded to be GMP compliant;

- The Receiving Authority shall send a written notice to the manufacturer stating the reasons in cases where it is concluded that the manufacturer is not yet GMP compliant;

d) Within 06 months from the date the Receiving Authority sends the GMP assessment report with a request to correct and remedy the deficiencies, the manufacturer must submit a written report on the correction and remedy as prescribed at Point b, Clause 2 of this Article. After this period, if the manufacturer does not submit the report on correction and remedy, or after 12 months from the date of the initial application submission that the Receiving Authority concludes the manufacturer is not yet GMP compliant, the submitted application dossier will no longer be valid.

3. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 3 as prescribed at Point c, Clause 3, Article 7 of this Circular:

a) The sequence and timeline for handling the GMP compliance assessment results shall comply with Clause 2 of this Article;

b) Within 20 days from the date of receiving the manufacturer's written report on the correction and remedy of deficiencies, the Receiving Authority shall conduct an on-site assessment of the correction and remedy at the manufacturer and conclude on the GMP compliance status of the manufacturer as prescribed in Clause 2, Article 7 of this Circular.

4. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 4 as prescribed at Point d, Clause 3, Article 7 of this Circular:

Within 05 working days from the date of finalizing the GMP assessment report, the Receiving Authority shall issue a written notice of non-compliance with GMP of the manufacturer made using Form No. 16 in Annex I to Decree No. 163/2025/ND-CP, accompanied by the GMP assessment report sent to the manufacturer, and shall not issue a Certificate of Eligibility for Pharmaceutical Business.

5. In cases where the manufacturer disagrees with a deficiency as assessed by the GMP Assessment Team, within 30 days from the date of finalization of the GMP assessment report or the corrective action assessment report, the manufacturer shall send a written petition to the Receiving Authority, accompanied by evidence (documents, photos, videos, certificates) proving its case related to that deficiency.

Within 10 days from the date of receiving the manufacturer's petition, the Receiving Authority shall organize a review of the GMP assessment report and the manufacturer's petition. If necessary, it shall consult with experts in the relevant field and provide a written response to the manufacturer. The written response must clearly state the acceptance or non-acceptance of the manufacturer's petition and the reasons for non-acceptance. This period shall not be counted towards the assessment time limit.

6. Within 05 working days from the date of issuing the Certificate of Eligibility for Pharmaceutical Business, the Receiving Authority shall publicly announce the following information on the electronic portal of the Ministry of Health and the website of the Receiving Authority:

a) Name and address of the manufacturer;

b) Full name of the person professionally responsible for pharmacy and the person in charge of quality assurance, accompanied by the reference numbers of their Pharmacy Practice Certificates;

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

d) Scope of pharmaceutical business (scope of manufacturing operations);

dd) Reference number of the GMP Certificate (if any);

e) Expiry date of the GMP compliance assessment.

Chapter IV

ASSESSMENT OF THE MAINTENANCE OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 9. Periodic assessment of the maintenance of compliance with Good Manufacturing Practices

1. The periodic assessment of the maintenance of GMP compliance at a manufacturer shall be conducted every 03 years, from the signing date of the written record of the preceding assessment (excluding ad-hoc assessments, inspections, or examinations by the Ministry of Health or provincial-level Departments of Health).

2. In November of each year, the Receiving Authority shall review and issue a plan for the periodic assessments of GMP compliance maintenance for manufacturers in the following year. The periodic assessment plan for GMP compliance maintenance shall be publicly announced on the website of the Receiving Authority. For manufacturers as prescribed in Clause 3, Article 6 of this Circular, the Drug Administration of Vietnam shall publicly announce and implement the periodic assessment plan for GMP compliance maintenance and assess GDP compliance maintenance if requested by a manufacturer.

3. At least 30 days prior to the scheduled date for the periodic assessment of GMP compliance maintenance as announced by the Receiving Authority, the manufacturer must submit a report on its manufacturing operations of medicinal products and medicinal materials and the maintenance of GMP standards (hereinafter referred to as the operation and GMP maintenance report) to the Receiving Authority, using Form No. 2 as prescribed in Annex X to this Circular, accompanied by updated technical documents on the manufacturer's physical infrastructure, technical conditions, and personnel (if there are any changes).

Example: If the scheduled date for the periodic assessment at manufacturer A is August 18, 2018, manufacturer A must submit the operation and GMP maintenance report to the Receiving Authority before July 18, 2018.

4. In cases where a manufacturer fails to submit the operation and GMP maintenance report by the deadline prescribed in Clause 3 of this Article, within 15 days from the due date, the Receiving Authority shall send a written request to the manufacturer to submit the report as required.

5. Within 45 days from the date of the Receiving Authority's written request, the manufacturer must submit the operation and GMP maintenance report along with an explanation for the late submission. If the manufacturer fails to submit the report after this period, the Receiving Authority shall conduct an ad-hoc assessment, inspection, or examination of the manufacturer's GMP compliance maintenance as prescribed in Article 12 of this Circular.

6. After submitting the operation and GMP maintenance report as required, the manufacturer may continue its operations of manufacturing medicinal products and medicinal materials in accordance with the Law on Pharmacy, relevant guiding documents, and within the scope of operations stated in its issued Certificate of Eligibility for Pharmaceutical Business, unless there is a written notice from a regulatory authority regarding non-compliance with GMP. The manufacturer must ensure the maintenance of GMP compliance during its operations. In cases where the manufacturer submits a written request, the Receiving Authority shall issue a written confirmation of the manufacturer's submission status of the operation and GMP maintenance report.

7. The assessment sequence, assessment process, and classification of GMP compliance assessment results shall comply with Articles 6 and 7 of this Circular.

8. In the event of epidemics, natural disasters, calamities, or wars that restrict travel and prevent the Receiving Authority from conducting the GMP compliance maintenance assessment as prescribed, the Receiving Authority shall:

a) Issue a GMP Certificate at the request of the manufacturer to serve its needs for exporting medicinal products and medicinal materials;

b) Conduct a remote assessment if it is a manufacturer of sterile medicinal products, biologicals, or in cases where the last assessment resulted in a compliance level of 3 or 4;

c) After the natural disaster, epidemic, or calamity has been overcome, the Receiving Authority shall conduct the GMP compliance maintenance assessment in accordance with Articles 6 and 7 of this Circular.

Article 10. Handling of results of the periodic assessment of the maintenance of Good Manufacturing Practices

1. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 1 as prescribed at Point a, Clause 3, Article 7 of this Circular:

a) Within 10 days from the date of finalizing the GMP assessment report, the Receiving Authority shall update the information on the manufacturer's GMP compliance maintenance on the electronic portal of the Ministry of Health and the website of the Receiving Authority as prescribed in Clause 6, Article 8 of this Circular and shall issue a GMP Certificate made using Form No. 05 in Annex X to this Circular for manufacturers that request it;

b) In cases where the manufacturer ceases one or more manufacturing operations within the certified scope stated on the Certificate of Eligibility for Pharmaceutical Business, the Receiving Authority shall update the information on GMP compliance maintenance for the manufacturing operations that were assessed as maintaining GMP compliance and shall send a written notice requesting the manufacturer to carry out the procedure for amending the Certificate of Eligibility for Pharmaceutical Business as prescribed at Point b, Clause 3, Article 36 of the Law on Pharmacy.

2. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 2 as prescribed at Point b, Clause 3, Article 7 of this Circular:

a) Within 05 working days from the date of finalizing the GMP assessment report, the Receiving Authority shall send a written notice requesting the manufacturer to correct and remedy the identified deficiencies made using Form No. 16 in Annex I to Decree No. 163/2025/ND-CP, accompanied by the GMP assessment report, for the manufacturer to correct and remedy the deficiencies and submit a corrective action report to the Receiving Authority;

b) Within 45 days from the date the Receiving Authority sends the GMP assessment report, the manufacturer must submit a corrective action report including a plan and supporting evidence (documents, photos, videos, certificates, or other supporting materials) of the correction and remedy of deficiencies recorded in the GMP assessment report;

c) Within 20 days from the date of receiving the corrective action report, the Receiving Authority shall assess the result of the correction by the manufacturer and conclude on its GMP compliance status:

- In cases where the manufacturer's corrective actions meet the requirements: The Receiving Authority shall update the information on the manufacturer's GMP compliance maintenance on the electronic portal of the Ministry of Health and the website of the Receiving Authority as prescribed in Clause 6, Article 8 of this Circular and shall issue a GMP Certificate made using Form No. 05 in Annex X to this Circular for manufacturers that request it;

- In cases where the manufacturer's corrective actions do not meet the requirements: The Receiving Authority shall send a written notice specifying the details that needs further correction and remedy and the submission of a supplementary report. The extension period for further correction, remedy, and reporting is 45 days from the date of the written request.

d) If, within 135 days from the date of finalizing the GMP assessment report, the manufacturer fails to submit a corrective action report, or if after implementing corrective actions as prescribed at Point c of this Clause, the result still fails to meet the requirements, the Receiving Authority shall issue a written notice of non-compliance with GMP and, depending on the nature and severity of the violation, shall apply one or more measures as prescribed at Points a and b, Clause 4 of this Article.

3. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 3 as prescribed at Point c, Clause 3, Article 7 of this Circular:

The sequence and timeline for handling the GMP compliance assessment results shall comply with Clause 2 of this Article.

Within 20 days from the date of receiving the corrective action report, the Receiving Authority shall conduct an on-site assessment of the corrective actions at the manufacturer before concluding on its GMP compliance status as prescribed at Point c, Clause 2 of this Article.

4. In cases where the GMP assessment report concludes that the manufacturer complies with GMP at level 4 as prescribed at Point d, Clause 3, Article 7 of this Circular:

Within 05 working days from the signing date of the written record of assessment, based on a risk assessment of the identified deficiencies with respect to the quality of medicinal products and medicinal materials and the safety of users, the Receiving Authority shall issue a written notice of non-compliance with GMP, accompanied by the written record of GMP assessment. Depending on the nature and severity of the violation, the Receiving Authority shall apply one or more of the following measures:

a) It shall issue a written suspension of the manufacturer's operations; impose administrative penalties or transfer the case to a competent authority for administrative penalties in accordance with the law on handling of administrative violations;

b) It shall propose to the Minister of Health to issue a decision to revoke the issued Certificate of Eligibility for Pharmaceutical Business as prescribed in Clause 2, Article 40 of the Law on Pharmacy if the manufacturer has not corrected and remedied the deficiencies by the end of the suspension period;

c) In cases where the manufacturer fails to comply with one or more manufacturing operations within the scope of business stated on the issued Certificate of Eligibility for Pharmaceutical Business, the Receiving Authority shall:

- Issue a written suspension of the manufacturer's operations with respect to the non-compliant scope; Impose administrative penalties or transfer the case to a competent authority for administrative penalties in accordance with the law on handling of administrative violations;

- Propose to the Minister of Health to issue a decision to revoke the issued Certificate of Eligibility for Pharmaceutical Business to remove the non-compliant scope of business as prescribed in Article 40 of the Law on Pharmacy if the manufacturer has not corrected and remedied the deficiencies related to the non-compliant scope by the end of the suspension period, and concurrently issue a Certificate of Eligibility for Pharmaceutical Business that is appropriate to the scope of business for which the manufacturer complies with GMP;

d) Revoke the GMP Certificate (if any) and issue a new GMP Certificate appropriate to the compliant scope if requested by the manufacturer.

5. Within 05 working days from the date of concluding that the manufacturer maintains GMP compliance or from the date of issuing a decision to revoke an issued Certificate of Eligibility for Pharmaceutical Business due to the manufacturer's failure to maintain GMP compliance, the Receiving Authority shall update the GMP compliance status on its website as prescribed in Clause 6, Article 8 of this Circular for compliant manufacturers, or information on the revocation of the Certificate of Eligibility for Pharmaceutical Business and GMP Certificate (if any) for non-compliant manufacturers.

6. In cases where samples of medicinal products or medicinal materials taken by the Assessment Team during the assessment are concluded to have quality defect, the Receiving Authority shall handle the defective medicinal products or medicinal materials in accordance with applicable regulations.

Article 11. Control of changes

1. Vaccine manufacturers, before making any change as prescribed at Points a and b of this Clause, must submit a written notification accompanied by an assessment of the risks and effects of the proposed changes on the quality and safety of the product:

a) Falling under the cases prescribed at Points d, dd, e, and g, Clause 2 of this Article;

b) Manufacturing or pilot manufacturing of vaccines or other medicinal products on a vaccine production line that has been certified;

Within 15 days, the Drug Administration of Vietnam shall provide a written response in case of disagreement with the proposed changes by the vaccine manufacturer.

2. After making a change, a manufacturer must carry out the procedure to apply for a Certificate of Eligibility for Pharmaceutical Business or report the change using Form No. 06 as prescribed in Annex X to this Circular if the change is one of the following:

a) A change as prescribed at Point b, Clause 1, Article 36 of the Law on Pharmacy;

b) Change of the location of the manufacturing plant at the same business address;

c) Addition of a new manufacturing plant at a new location at the same business address;

d) Expansion of the manufacturing plant or major changes in the structure or facility layout of one or more production lines or the entire plant based on the existing plant structure;

dd) Repair or change in the structure or facility layout of a part of a production line that alters the manufacturing environment or manufacturing process;

e) Change of major, critical production equipment that affects the manufacturing process or the quality of the medicinal product or medicinal material;

g) Change in the auxiliary system or change in the design principle or operation of the utility system that affects the manufacturing environment;

h) The manufacturer switches its scope of manufacturing between the scope of manufacturing chemical medicinal products including both prescription and over-the-counter chemical medicinal products and the scope of only manufacturing over-the-counter chemical medicinal products.

3. In cases where a manufacturer has a change as prescribed at Point a, Clause 2 of this Article, the manufacturer must submit a dossier of application for a Certificate of Eligibility for Pharmaceutical Business as prescribed in Clause 2 and Clause 4, Article 38 of the Law on Pharmacy.

The sequence for assessing GMP compliance, classifying the results, and handling the assessment results of the level of GMP compliance shall comply with Articles 6, 7, and 8 of this Circular.

4. In cases where a manufacturer has any change as prescribed at Points b, c, or d, Clause 2 of this Article, or in cases where a manufacturer of sterile medicinal products or medicinal materials has any change as prescribed at Points dd, e, and g, Clause 2 of this Article, the manufacturer must submit a change report with corresponding technical documents to the Receiving Authority.

a) The Receiving Authority shall conduct an on-site assessment at the manufacturer. In cases where the manufacturer meets the requirements, the Receiving Authority shall issue a written approval of the manufacturer's changes;

b) The sequence for assessment, classification of results, and handling of assessment results for a manufacturer with changes as prescribed at Point b, Clause 2 of this Article shall comply with Articles 6, 7, and 10 of this Circular;

c) The sequence for assessment, classification of results, and handling of assessment results for a manufacturer with changes as prescribed at Point c or d, Clause 2 of this Article, or a manufacturer of sterile medicinal products or medicinal materials with changes falling under Points dd, e, and g, Clause 2 of this Article shall comply with Articles 6, 7, and 8 of this Circular.

5. In cases where a manufacturer of medicinal products or medicinal materials has a change falling under one of the cases prescribed at Points dd, e, or g, Clause 2 of this Article (unless otherwise prescribed in Clause 4 of this Article), the manufacturer must submit a change report with corresponding technical documents to the Receiving Authority. The manufacturer must continue to ensure that its operations are maintained in accordance with GMP principles and standards.

The Receiving Authority shall conduct an ad-hoc assessment and handle the assessment results in accordance with Article 12 of this Circular in cases where the change report does not provide sufficient evidence of maintaining GMP compliance at the manufacturer.

6. In cases where a manufacturer of medicinal products or medicinal materials has a change as prescribed at Point h, Clause 2 of this Article, the manufacturer shall carry out the procedure to amend the Certificate of Eligibility for Pharmaceutical Business as prescribed in Clause 1, Article 20 of Decree No. 163/2025/ND-CP;

7. In cases where a manufacturer is validated as compliant with EU-GMP or EU-GMP equivalent by a Stringent Regulatory Authority (SRA) or a drug regulatory authority recognized by the Ministry of Health based on WHO classification and requests for public announcement thereof on the website of the Receiving Authority:

a) The manufacturer shall submit a written request for public announcement accompanied by the GMP Certificate or a document concluding that the manufacturer complies with EU-GMP, EU-GMP equivalent, the GMP inspection report promulgated by the SRA, or the drug regulatory authority recognized by the Ministry of Health based on WHO classification;

b) Within 15 days from the date of receiving the application dossier, the Receiving Authority shall review the application dossier and cross-check it with the information on the manufacturing operations within the certified scope stated on the Certificate of Eligibility for Pharmaceutical Business of the manufacturer and publicly announce it on the electronic portal of the Ministry of Health and the website of the Receiving Authority. The information to be publicly announced includes:

- Name and address of the manufacturer (Address of the assessed plant/production line);

- Reference number of the EU-GMP or EU-GMP equivalent certificate or the document concluding compliance with EU-GMP or equivalent; its validity period and the issuing authority;

- The assessed scope of manufacturing operations of the manufacturer corresponding to the GMP certificate.

Article 12. Ad-hoc assessment and inspection of the maintenance of compliance with Good Manufacturing Practices

1. The inspection of the maintenance of GMP compliance by a manufacturer shall comply with the law regulations.

2. The Receiving Authority shall conduct an ad-hoc assessment of the maintenance of GMP compliance at a manufacturer in one of the following cases:

a) The manufacturer's corrective actions have not met the requirements as prescribed in Item 2, Point c, Clause 6, Article 11 of this Circular;

b) A manufacturer that complies with GMP at level 3 or 4 as prescribed at Points c and d, Clause 3, Article 7 of this Circular must undergo an ad-hoc assessment at least once within 03 (three) years from the end date of the preceding assessment period;

c) The manufacturer has had 01 batch of medicinal product recalled due to a level 1 violation;

d) The manufacturer has a medicinal product with serious adverse reactions or a series of adverse drug reactions (ADRs) as reported by the National Drug Information and Adverse Drug Reaction Center, including serious ADRs that directly affect the quality, safety, and efficacy of the medicinal product;

dd) The manufacturer has inspection results from a competent authority concluding a serious violation of GMP principles and standards;

e) There is information reflecting or denouncing that the manufacturer has seriously violated GMP principles and standards;

g) The manufacturer fails to submit the operation and GMP maintenance report as prescribed in Clause 5, Article 9 of this Circular;

h) A manufacturer of over-the-counter chemical medicinal products when implementing the manufacturing of herbal medicinal products, traditional medicinal products, or health supplements.

3. The composition of the Assessment Team shall be decided by the Head of the Receiving Authority in accordance with Article 19 of this Circular.

4. The sequence for an ad-hoc assessment at a manufacturer shall comply with Article 7 of this Circular.

5. The handling of the results of ad-hoc inspections and assessments at a manufacturer shall comply with the law regulations.

Article 13. Assessment of compliance and maintenance of compliance with Good Manufacturing Practices for domestic manufacturers of medicinal products and medicinal materials not subject to the issuance of Certificates of Eligibility for Pharmaceutical Business

1. Manufacturers not subject to the issuance of Certificates of Eligibility for Pharmaceutical Business (manufacturers with pharmaceutical operations but not for commercial purposes) must comply with GMP as prescribed at Point a, Clause 2, Article 35 of the Law on Pharmacy.

2. Manufacturers not subject to the issuance of Certificates of Eligibility for Pharmaceutical Business (except for the dispensing departments of medical examination and treatment establishments) shall submit a written request for GMP compliance assessment using Form No. 1 as prescribed in Annex X to this Circular and technical documents on the manufacturer presented according to the guidance on the Site Master File as prescribed in Annex VIII to this Circular for an initial assessment, or an operation and GMP maintenance report of the manufacturer, accompanied by updated technical documents on the manufacturer (if there are any changes) as prescribed in Clause 3, Article 9 for a periodic assessment.

3. The assessment sequence, assessment process, classification of assessment results, control of changes, and ad-hoc assessment of GMP compliance for manufacturers of medicinal products and medicinal materials not subject to the issuance of Certificates of Eligibility for Pharmaceutical Business shall comply with the corresponding provisions in Articles 6, 7, 9, 11, and 12 of this Circular.

4. Handling of initial assessment results of GMP compliance for a manufacturer of medicinal products or medicinal materials not subject to the issuance of a Certificate of Eligibility for Pharmaceutical Business:

a) The sequence and timeline for handling the initial assessment results of GMP compliance of the manufacturer shall comply with Article 8 of this Circular;

b) The Receiving Authority shall issue a written notice of the GMP compliance status of the manufacturer and publicly announce it on the electronic portal of the Ministry of Health and the website of the Receiving Authority as prescribed in Clause 6 of this Article.

5. Handling of results of periodic assessments, ad-hoc inspections and assessments of the maintenance of GMP compliance for manufacturers of medicinal products and medicinal materials not subject to the issuance of a Certificate of Eligibility for Pharmaceutical Business:

a) In cases where the inspection and assessment results conclude that the manufacturer complies with GMP at level 1, 2, or 3 as prescribed at Points a, b, and c, Clause 3, Article 7 of this Circular, the inspecting and assessing authority shall handle it in accordance with Clauses 1, 2, and 3, Article 10 of this Circular;

b) In cases where the inspection and assessment results conclude that the manufacturer complies with GMP at level 4 as prescribed at Point d, Clause 3, Article 7 of this Circular, the inspecting and assessing authority shall issue a decision to temporarily suspend all manufacturing operations or the non-compliant scope of manufacturing operations until the manufacturer has corrected and remedied the deficiencies to meet the requirements;

c) In cases where samples of medicinal products or medicinal materials taken by the Assessment Team during the inspection and assessment are concluded to have quality defect, the Receiving Authority shall handle the defective medicinal products or medicinal materials in accordance with applicable regulations on the quality management of medicinal products and medicinal materials. The head of the manufacturer shall take accountability to the law for this violation.

6. Within 05 working days from the date of concluding the compliance/maintenance of GMP compliance of a manufacturer of medicinal products or medicinal materials not subject to the issuance of a Certificate of Eligibility for Pharmaceutical Business, the Receiving Authority shall publicly announce and update the following information on the electronic portal of the Ministry of Health and the website of the Receiving Authority:

a) Name and address of the manufacturer;

b) Full name of the person professionally responsible for pharmacy, the person in charge of quality assurance, and the reference numbers of their Pharmacy Practice Certificates;

c) Reference number of the GMP Certificate;

d) Expiry date of the GMP compliance assessment;

dd) Scope of operations of the manufacturer.

Chapter V

TECHNICAL PROCESS FOR ASSESSING COMPLIANCE AND MAINTENANCE OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICES OF FOREIGN MANUFACTURERS OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS UPON REGISTRATION FOR MARKETING AUTHORIZATION IN VIETNAM

Article 14. Receipt and organization of assessment of compliance and maintenance of compliance with Good Manufacturing Practices of foreign manufacturers of medicinal products and medicinal materials

1. Dossier reception:

The manufacturer, or the applicant for registration of the medicinal product or medicinal material, shall submit 01 (one) dossier of application for assessment of compliance and maintenance of GMP compliance of the foreign manufacturer of medicinal products or medicinal materials as prescribed in Clause 2, Article 97 of Decree No. 163/2025/ND-CP, along with the validation fee as prescribed by the Minister of Finance for the validation of standards and conditions for manufacturing, to the Receiving Authority of the Ministry of Health which shall be:

a) The Agency of Traditional Medicine Administration, if the foreign manufacturer of medicinal products or medicinal materials only manufactures herbal medicinal materials, traditional medicinal products, and traditional medicinal ingredients at the time of dossier submission;

b) The Drug Administration of Vietnam, if the foreign manufacturer of medicinal products or medicinal materials manufactures medicinal materials (excluding herbal medicinal materials), chemical medicinal products, herbal medicinal products, vaccines, and biologicals at the time of dossier submission;

c) The Drug Administration of Vietnam, if the foreign manufacturer of medicinal products or medicinal materials concurrently manufactures one of the medicinal products or medicinal materials prescribed at Point a of this Clause and one of the medicinal products or medicinal materials prescribed at Point b of this Clause at the time of dossier submission.

2. The Receiving Authority shall organize the receipt, validation, and assessment of the dossier of application for assessment of compliance and maintenance of GMP compliance of the foreign manufacturer of medicinal products or medicinal materials. The dossier of application for assessment, sequence, and details of the assessment of compliance and maintenance of GMP compliance of the foreign manufacturer of medicinal products or medicinal materials shall comply with Clauses 2, 3, 4 of Article 93; Clauses 2, 3, 4 of Article 94; Clauses 2, 3, 4 of Article 95; Clauses 1, 2, 3, 4 of Article 96; Clauses 2, 3, 4, 5, 6, 7 of Article 97 of Decree No. 163/2025/ND-CP.

3. The documents on GMP principles and standards serving as the basis for assessing GMP compliance at the foreign manufacturer shall comply with Clause 1, Article 97 of Decree No. 163/2025/ND-CP.

4. Based on its assigned functions and tasks, the Receiving Authority shall establish an expert team for validation, develop regulations, and organize the operations of the expert team to assess the dossiers of application for assessment of compliance and maintenance of GMP compliance and announce the status of compliance and maintenance of GMP compliance of foreign manufacturers of medicinal products and medicinal materials. The cost of organizing the dossier assessment shall comply with the law regulations.

5. Operational principles for experts:

a) Validation opinions must be based on legal grounds and scientific evidence and must be recorded in the written record of validation;

b) The expert validator shall take accountability to the Head of the Receiving Authority for the validation details and proposed opinions related to the validation work.

Article 15. Technical procedure for assessing compliance and maintenance of compliance with Good Manufacturing Practices for manufacturers of medicinal products and medicinal materials as prescribed in Articles 93, 94, 95, and 96 of Decree No. 163/2025/ND-CP

1. Within 02 working days from the date of receipt, the Receiving Authority shall review the suitability of the proposed assessment form and forward the application dossier along with the corresponding written record of validation to the expert validator.

2. Within 08 days in cases where the applicant submits additional documents as prescribed at Point e, Clause 2, Article 93 or as prescribed in Clause 2, Article 94 or Clauses 1 and 2, Article 96 of Decree No. 163/2025/ND-CP, and 30 days in cases where the application dossier only includes documents as prescribed at Points a, b, c, d, dd, Clause 2, Article 93 of Decree No. 163/2025/ND-CP dated June 29, 2025, the Expert Assessment Team shall assess the application dossier according to the assessment details prescribed in Clause 4 of Articles 93, 94, 95, and 96 of Decree No. 163/2025/ND-CP, fill in the assessment information for each detail in the written record of assessment, and provide a conclusion on the GMP compliance status of the manufacturer.

3. Within 04 working days from receiving the conclusion of the Expert Team, the Receiving Authority shall review the expert's conclusion and approve the validation result.

In cases where the experts do not reach a consensus, the Receiving Authority shall return the dossier for the experts to review and reach a consensus. In cases where the experts still do not reach a consensus, the Receiving Authority shall organize an expert group including the initial experts and 02 other experts to jointly assess and conclude on the dossier. In cases where the experts still do not reach a consensus, the Receiving Authority shall review the entire dossier and the experts' opinions and make a final conclusion.

4. Within 01 working day from the date of concluding on the dossier, the Receiving Authority shall issue a written notice of the result of the GMP compliance status of the manufacturer. In cases where the dossier has not yet met or fails to meet GMP, the written response must clearly state the reasons.

5. Within 03 working days from the date of the compliance assessment result, the Receiving Authority shall publicly announce information on the foreign manufacturer of medicinal products or medicinal materials that has been assessed as complying with or maintaining GMP compliance on the electronic portal of the Ministry of Health and the website of the Receiving Authority.

6. The Receiving Authority shall process the supplementary dossier of the manufacturer following the sequence prescribed in Clauses 1, 2, 3, 4, 5 above within the following time limits:

a) Within 15 days from the date of receiving the supplementary dossier as requested in Clause 4 of this Article in cases where the applicant submits the dossier as prescribed in Clause 2, Article 94 or Clauses 1 and 2, Article 96 of Decree No. 163/2025/ND-CP;

b) Within 30 days from the date of receiving the supplementary dossier as requested in Clause 4 of this Article in cases where the applicant submits the dossier as prescribed in Clause 2, Article 93 of Decree No. 163/2025/ND-CP.

Article 16. Technical procedure for assessing compliance with Good Manufacturing Practices for manufacturers of medicinal products and medicinal materials through on-site assessment at the manufacturer as prescribed in Article 95 of Decree No. 163/2025/ND-CP

1. Within 15 days from the date of receiving a complete dossier in cases prescribed at Points b, d, and dd, Clause 1, Article 95 of Decree No. 163/2025/ND-CP, or from the date of notifying the validation results of the dossier for the registration of the medicinal product or the dossier of application for assessment of compliance with Good Manufacturing Practices in cases prescribed at Points a and c, Clause 1, Article 95 of Decree No. 163/2025/ND-CP, the Receiving Authority shall review the suitability of the proposed assessment form, review the completeness of the application dossier, develop an inspection plan, and issue a decision to form an On-site Assessment Team at the foreign manufacturer of medicinal products or medicinal materials as prescribed in Articles 18 and 19 of this Circular, and forward the application dossier to the members of the Assessment Team. In cases where the dossier is incomplete, the Receiving Authority shall request supplementation in writing.

2. Within 30 days from the date of the Decision to form the Assessment Team, the Head of the Assessment Team shall assign members to prepare for the overseas mission, develop an Assessment Program, and send it to the assessed manufacturer. The Assessment Program must be consistent with the assessment details prescribed in Clause 4, Article 95 of Decree No. 163/2025/ND-CP, and appropriate for the dosage form of the registered medicinal product or medicinal material/the manufacturing scope of the manufacturer. The Assessment Program may be adjusted during the assessment if points requiring more thorough assessment or expansion of the scope or subject of assessment are identified.

3. Within 15 days from the date of sending the Assessment Program to the manufacturer, the Assessment Team shall conduct the on-site inspection. The on-site inspection process shall comply with Points a, b, c, d, dd, Clause 2, Article 7 of this Circular. The Assessment Program may be adjusted according to the deficiencies of the manufacturer identified during the assessment.

4. Within 20 days from the end of the on-site assessment, the Assessment Team shall prepare a Good Manufacturing Practices assessment report made using Form No. 04 as prescribed in Annex X to this Circular. The assessment report shall be reviewed, finalized, and signed by the members of the Team and sent to the Receiving Authority. The classification of deficiencies and the level of GMP compliance of the manufacturer shall comply with Clause 3, Article 7 and Annex IX to this Circular.

5. Within 10 days from the date of receiving the written record of assessment from the Assessment Team, the Receiving Authority shall review the written record of assessment, the assessment details, and the conclusion on the level of compliance in the GMP written record of assessment, discuss the assessment results of the Assessment Team if necessary, and issue a written notice of the conclusion on the GMP compliance of the manufacturer. In cases where the manufacturer has not yet met or fails to meet GMP, the written response must clearly state the reasons.

6. Within 03 working days from the date of concluding that the manufacturer is GMP compliant, the Receiving Authority shall publicly announce information on the foreign manufacturer that has been assessed as GMP compliant on the electronic portal of the Ministry of Health and the website of the Receiving Authority.

7. The sequence for handling supplementary dossiers as requested in Clause 5 of this Article is as follows:

a) Within 01 working day from the date of receiving the supplementary dossier, the Receiving Authority shall forward the supplementary dossier to the Assessment Team;

b) Within 29 days from the date of receiving the supplementary dossier, the Assessment Team shall review and assess the supplementary dossier of the manufacturer; prepare a supplementary dossier assessment report, provide an opinion on the GMP compliance level of the manufacturer, and send it to the Receiving Authority;

c) Within 10 days from the date of receiving the supplementary dossier assessment report from the Assessment Team, the Receiving Authority shall review the assessment report, the conclusion on the GMP compliance level by the Assessment Team, discuss and clarify (if necessary); and issue a written notice of the conclusion on GMP compliance to the manufacturer or the applicant for medicinal product registration named in the dossier of application for GMP compliance assessment. In cases where the manufacturer has not yet met or fails to meet GMP, the written response to the manufacturer must clearly state the reasons.

Article 17. Information to be publicly announced on the compliance with Good Manufacturing Practices of foreign manufacturers of medicinal products and medicinal materials

1. Within 03 working days from the date of the assessment result concluding that the manufacturer is GMP compliant, the Receiving Authority shall publicly announce and update the assessment results of GMP compliance of the foreign manufacturer of medicinal products or medicinal materials on the electronic portal of the Ministry of Health and the website of the Receiving Authority. The information to be publicly announced includes:

a) Name and address of the manufacturer (address of the assessed plant/production line);

b) Reference number of the GMP Certificate/Manufacturing License/GMP Inspection Report or other documents as prescribed in Clause 5, Article 97 of Decree No. 163/2025/ND-CP promulgated by the competent authority of the host country, and its validity period; GMP principles and standards and the issuing authority of the Certificate or the assessing authority. In cases where the manufacturer is in a PIC/S member country, the PIC/S-GMP principles and standards shall be included along with the GMP principles and standards stated on the GMP Certificate/Manufacturing License/GMP Inspection Report;

c) Reference number of the EU-GMP or EU-GMP equivalent Certificate/Manufacturing License/GMP Inspection Report, its validity period, and issuing authority if the manufacturer has been assessed as compliant with EU-GMP or EU-GMP equivalent by a Stringent Regulatory Authority (SRA) or a drug regulatory authority recognized by the Ministry of Health based on WHO classification;

d) The assessed scope of manufacturing operations of the manufacturer corresponding to each GMP Certificate.

2. Validity period of compliance with Good Manufacturing Practices for medicinal products:

a) The validity period stated on the GMP Certificate, Manufacturing License, or Good Manufacturing Practices Inspection Report;

b) Regulations of the drug regulatory authority/competent authority of the issuing/assessing country regarding GMP compliance;

c) Policy on extension or prolongation of the validity period of GMP compliance of the issuing/assessing authority.

3. The scope of GMP compliance certification is determined based on the following:

a) The scope of GMP certification requested for assessment by the applicant for registration or the manufacturer of the medicinal product or medicinal material;

b) The scope of certification stated on the GMP Certificate/Manufacturing License or GMP Inspection Report;

c) The conditions of the facilities and production equipment of the manufacturer.

Chapter VI

MEMBERS OF THE ON-SITE ASSESSMENT TEAM AND DOSSIER EXPERT ASSESSORS FOR COMPLIANCE WITH GOOD MANUFACTURING PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 18. Standards for members of the Assessment Team for compliance and maintenance of compliance with Good Manufacturing Practices through on-site inspection at the manufacturer, and expert assessors for dossiers of application for assessment of compliance and maintenance of Good Manufacturing Practices

1. A member of the Assessment Team for compliance and maintenance of GMP compliance through on-site inspection at the manufacturer, or an expert assessor for the dossier of application for assessment of CMP compliance and maintenance must meet the following standards:

a) He/she must hold a university degree or higher and have been trained in medical, pharmaceutical, biological sciences, quality management of medicinal products, and pharmaceutical administration;

b) He/she must have been trained and coached in GMP, GMP inspection and assessment, and have a firm grasp of GMP principles and standards. Particularly, a member participating in the Assessment Team for a manufacturer of traditional medicinal products or herbal medicinal materials must have been trained and coached in GMP for traditional medicinal products and herbal medicinal materials;

c) He/she must be honest and objective, and strictly comply with regulations and legal provisions during the assessment process, and have no conflict of interest with the assessed manufacturer as prescribed in Clause 4 of this Article;

d) The Head of the Assessment Team must have at least 03 (three) years of experience in pharmaceutical administration.

2. The composition of the Assessment Team for compliance and maintenance of GMP compliance through on-site inspection at a manufacturer includes:

a) The Head of the Team and 01 or 02 members from the Receiving Authority. If the manufacturer is prescribed at Point c, Clause 1, Article 6 of this Circular, 01 or 02 members from the Agency of Traditional Medicine Administration shall be added;

b) 01 member who is a representative of the National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, or the National Institute for Control of Vaccines and Biologicals (if it is a vaccine or biologicals manufacturer);

c) 01 member who is a representative of the provincial-level Department of Health of the locality where the domestic manufacturing plant of medicinal products or medicinal materials is located;

d) Members from relevant agencies, where necessary.

3. Composition of the expert assessors for the dossier of application for assessment of compliance and maintenance of GMP compliance of foreign manufacturers of medicinal products and medicinal materials:

a) 02 experts for the dossier of application for GMP compliance assessment of a manufacturer through the form of recognition or mutual recognition of inspection results by the state drug regulatory authority regarding compliance requirements, and the dossier of application for assessment of GMP compliance maintenance of such manufacturer;

b) 03 experts for the dossier of application for GMP compliance assessment of a manufacturer through the form of dossier validation related to manufacturing conditions, and the dossier of application for assessment of GMP compliance maintenance of such manufacturer.

4. Principle for assessing conflict of interest: A member of the on-site Assessment Team or a dossier expert assessor is considered to have a conflict of interest with the assessed manufacturer if he/she falls under one of the following cases:

a) He/she has worked for or participated in consulting operations within the last 05 years for the assessed manufacturer;

b) He/she currently has a financial interest in the assessed manufacturer;

c) He/she has a spouse, child, parent, sibling, or parent-in-law who is currently working for the assessed manufacturer.

Article 19. Responsibilities and powers of members of the on-site assessment team and dossier expert assessors

1. The Assessment Team shall:

a) Assess all operations of the manufacturer in accordance with the corresponding GMP principles and standards as prescribed in Article 3 of this Circular, the updated version of GMP principles and standards, and relevant legal and professional regulations; specifically record the assessment details and identified deficiencies, prepare a written record of validation for dossier assessment and an assessment record/report for on-site assessment; validation and assessment opinions must be based on legal grounds and scientific evidence and must be reflected in the written record of validation for dossier assessment and the written record of assessment for on-site assessment;

b) Report the assessment results or provide explanations on the GMP assessment report in cases where the manufacturer disagrees with the details of the GMP assessment report;

c) Take accountability to the Receiving Authority for details of the assessment. Maintain the confidentiality of all information related to the assessment details and all information related to the manufacturing, quality control, storage, and distribution of medicinal products (manufacturing processes, testing procedures, cleaning, trade secrets, etc.), unless with the consent of the manufacturer or at the request of a competent state authority for inspection or investigation purposes.

2. The Assessment Team has the rights to:

a) Inspect all areas and facilities of the manufacturer, and have the right to request inspection of other areas related to the manufacturing, storage, and testing of medicinal products and medicinal materials. Particularly for the manufacturing of traditional medicinal ingredients, additionally inspect the processing and manufacturing procedures of traditional medicinal ingredients of the proposed manufacturer;

b) Request the provision of dossiers and documents related to quality management, manufacturing, testing, and storage of medicinal products and medicinal materials;

c) Collect dossiers, documents, and evidence (photocopying documents, taking photos, recording videos, etc.) of deficiencies found during the assessment;

d) Take samples of medicinal products, semi-finished products, herbal medicinal materials, and medicinal materials for quality control testing in accordance with the law;

dd) Draw a written record and request the manufacturer to temporarily suspend one, some, or all manufacturing operations related to the violation. If, during the assessment, the Assessment Team discovers that the manufacturer has violations that seriously affect the quality of one or more medicinal products or medicinal materials, it must report to the competent authority for handling in accordance with the law regulations.

3. Dossier expert assessors shall:

a) Assess and review the GMP compliance of the manufacturer through dossier review and assessment to publicly announce the List of foreign manufacturers of medicinal products and medicinal materials that meet GMP requirements when registering for marketing authorization in Vietnam; to prepare a written record of validation for dossier assessment and record corresponding comments for each item on the written record of validation and provide opinions on the validated dossier; validation and assessment opinions must be based on legal grounds and scientific evidence and must ensure completeness, accuracy, and compliance with the provisions of legal documents on good manufacturing practices for medicinal products and medicinal materials, guiding documents, technical guidelines, and specialized documents related to the manufacturing of medicinal products and medicinal materials;

b) Take accountability to the Receiving Authority for details of the assessment. Maintain the confidentiality of all information related to the assessment details and all information related to the manufacturing, quality control, storage, and distribution of medicinal products (manufacturing processes, testing procedures, cleaning, trade secrets, etc.), unless with the consent of the manufacturer or at the request of a competent state authority for inspection or investigation purposes.

4. Dossier expert assessors have the rights to:

a) Be provided with all legal documents and guiding documents related to good manufacturing practices for medicinal products and medicinal materials to serve the assessment;

b) Be able to request the provision of supplementary dossiers in accordance with the law to serve the assessment;

c) Be able to propose an on-site assessment at the manufacturer for the dossier of application for GMP compliance assessment of a foreign manufacturer of medicinal products or medicinal materials as prescribed at Point c, Clause 1, Article 95 of Decree No. 163/2025/ND-CP.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 20. Effect

1. This Circular takes effect on July 01, 2025.

2. The following documents and regulations shall cease to be effective from the effective date of this Circular:

a) Circular No. 35/2018/TT-BYT dated November 22, 2018, of the Minister of Health prescribing Good Manufacturing Practices for medicinal products and medicinal materials;

b) Circular No. 12/2022/TT-BYT dated November 21, 2022, of the Ministry of Health amending and supplementing a number of articles of Circular No. 35/2018/TT-BYT dated November 22, 2018, of the Minister of Health prescribing Good Manufacturing Practices for medicinal products and medicinal materials;

c) Clause 6, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020, amending, supplementing, and annulling a number of legal documents promulgated or jointly promulgated by the Minister of Health.

Article 21. Reference clauses

In cases where a legal document or regulation referred to in this Circular is amended or replaced, the newest one shall apply.

Article 22. Transitional provisions

1. For dossiers of application for Certificates of Eligibility for Pharmaceutical Business or dossiers of registration for periodic GMP compliance assessment submitted to the Receiving Authority before the effective date of this Circular, the Receiving Authority shall continue to assess the manufacturer in accordance with Circular No. 35/2018/TT-BYT prescribing Good Manufacturing Practices for medicinal products and medicinal materials or in accordance with this Circular if requested by the manufacturers.

2. For manufacturers currently producing prescription chemical medicinal products that change their scope of operation to only produce over-the-counter chemical medicinal products, they must:

a) Carry out the procedure to amend their Certificates of Eligibility for Pharmaceutical Business as prescribed in Clause 1, Article 20 of Decree No. 163/2025/ND-CP;

b) Cease the production of prescription chemical medicinal products from the date of being issued the Certificates of Eligibility for Pharmaceutical Business as prescribed at Point a of this Clause; and concurrently carry out the legal procedures to withdraw the Marketing Authorizations for medicinal products and medicinal materials for prescription medicinal products.

Article 23. Responsibilities for implementation

1. The Drug Administration of Vietnam is responsible for:

a) Assuming the prime responsibility for, and coordinating with relevant units, in organizing the implementation, dissemination, and popularization of this Circular according to its assigned functions and tasks;

b) Implementing this Circular for provincial-level Departments of Health, sector-specific health authorities, and manufacturers of medicinal products and medicinal materials within its assigned scope of functions and tasks;

c) Compiling and publicly announcing on the website of the Drug Administration of Vietnam a list of manufacturers nationwide that have been issued with Certificates of Eligibility for Pharmaceutical Business and/or GMP Certificates; updating the status of the Certificates of Eligibility for Pharmaceutical Business and/or GMP Certificates, GMP compliance status, and other information as prescribed in Clause 6, Article 8 of this Circular according to its assigned scope of functions and tasks;

d) Publishing updated GMP documents on the electronic portal of the Ministry of Health and the website of the Drug Administration of Vietnam;

dd) Acting as the focal point or coordinating with relevant agencies to inspect and examine GMP compliance and handle violations within its competence.

2. The Agency of Traditional Medicine Administration shall be responsible for:

a) Assuming the prime responsibility for, and coordinating with relevant units, in organizing the implementation, dissemination, and popularization of this Circular according to its assigned functions and tasks;

b) Compiling and publicly announcing on the website of the Agency of Traditional Medicine Administration a list of manufacturers nationwide that have been issued with Certificates of Eligibility for Pharmaceutical Business or GMP Certificates, updating the status of the Certificates of Eligibility for Pharmaceutical Business or GMP Certificates, GMP compliance status, and other information as prescribed in Clause 6, Article 8 of this Circular according to its assigned scope of functions and tasks;

c) Coordinating with the Drug Administration of Vietnam in assessing, issuing certificates, and announcing compliance with Good Manufacturing Practices for manufacturers as prescribed at Point c, Clause 1, Article 6 of this Circular upon the issuance of decisions to form teams;

d) Acting as the focal point or coordinating with relevant agencies to inspect and examine GMP compliance and handle violations within its competence.

3. Provincial-level Departments of Health are responsible for:

a) Coordinating with relevant units to organize the dissemination and popularization of this Circular and guide its implementation for units within their respective localities;

b) Participating in teams for inspection, examination, and assessment of GMP compliance; supervising and handling violations within their competence with respect to manufacturers of medicinal products and medicinal materials in their respective localities.

4. The National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, and the National Institute for Control of Vaccines and Biologicals shall be responsible for participating in the Assessment Team for GMP compliance upon the issuance of a decision to form a team.

5. Manufacturers of medicinal products and medicinal materials shall be responsible for:

a) Organizing the implementation of this Circular;

b) Ensuring constant compliance with GMP principles and standards throughout their operations;

c) Carrying out manufacturing operations in strict accordance with the assessed and licensed scope on the basis of compliance with law regulations;

d) Manufacturers of finished and semi-finished medicinal products, based on the purpose and scope of use of excipients at their facilities, shall conduct self-assessments of compliance with the GMP principles and standards prescribed at Point dd, Clause 1, Article 3 and Point b, Clause 3, Article 3 of this Circular for the excipients used at the manufacturers;

dd) Manufacturers of medicinal products that also produce health supplements or semi-finished health supplements as prescribed in Clause of Article 4 must fully comply with relevant law regulations on the management of health supplements.

In the course of implementation, should any difficulties or problems arise, agencies, organizations, and individuals shall report to the Ministry of Health (the Drug Administration of Vietnam, the Agency of Traditional Medicine Administration) for consideration and resolution./.