Circular No. 28/2025/TT-BYT stipulates Good Manufacturing Practice (GMP) for the production of drugs and drug ingredients issued by the Minister of Health.

CIRCULAR

REGULATIONS ON GOOD MANUFACTURING PRACTICES FOR THE PRODUCTION OF DRUGS AND DRUG SUBSTANCES

Pursuant to the Medicine Law 2016 and the Law Amending and Supplementing Certain Provisions of the Medicine Law 2024;

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

Pursuant to Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government detailing certain provisions and measures for implementing the Medicine Law;

At the proposal of the Director of the Department of Medicine Management, the Director of the Department of Traditional Medicine and Pharmaceutical Management;

The Minister of Health issues this Circular on Good Manufacturing Practices for the Production of Drugs and Drug Substances.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the publication of application, issuance of principles and standards of Good Manufacturing Practices for the Production of Drugs and Drug Substances, and the evaluation and maintenance of compliance with Good Manufacturing Practices for the Production of Drugs and Drug Substances.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Good Manufacturing Practices for the Production of Drugs and Drug Substances (hereinafter referred to as Good Manufacturing Practices for Production) is a set of principles and standards for the production of drugs and drug substances aimed at ensuring that drugs and drug substances are consistently produced and inspected according to appropriate quality standards suitable for their intended use and the requirements of the drug registration certificate.

2. Production facility (including chemical drug manufacturing facilities, herbal medicine manufacturing facilities, vaccine manufacturing facilities, bioproduct manufacturing facilities, traditional medicine manufacturing facilities, traditional medicine ingredient manufacturing facilities, drug substance manufacturing facilities, herbal medicine facilities) is a facility engaged in pharmaceutical activities subject to licensing or not subject to licensing for the operation of pharmaceutical business within the scope of performing one, several, or all stages of the drug and drug substance production process.

3. Non-compliance is deviation from the principles and standards of Good Manufacturing Practices (GMP) or from current laws and regulations governing pharmaceutical management.

4. GMP is an abbreviation for the English phrase "Good Manufacturing Practices," which translates to Vietnamese as "Good Manufacturing Practices."

5. WHO is an abbreviation for the English term "World Health Organization," which translates to Vietnamese as "World Health Organization."

6. WHO-GMP is an abbreviation for "Good Manufacturing Practices of the World Health Organization."

7. PIC/S is an abbreviation for the English phrase "Pharmaceutical Inspection Co-operation Scheme," which translates to Vietnamese as "Pharmaceutical Inspection Cooperation System."

8. PIC/S-GMP is an abbreviation for "Good Manufacturing Practices of the Pharmaceutical Inspection Cooperation System."

9. EU is an abbreviation for the English term "European Union," which translates to Vietnamese as "European Union."

10. EU-GMP is an abbreviation for "Good Manufacturing Practices of the European Union."

11. stands for "United States," which is translated into Vietnamese as "United States" is an abbreviation for the English term "United States," which translates to Vietnamese as "United States."

12. SRA is an abbreviation for the English term "Stringent Regulatory Authorities," which translates to Vietnamese as "Strict Regulatory Authorities" as defined by WHO.

13. Equivalent to EU-GMP are principles and standards of GMP issued by strict regulatory authorities in SRA countries.

Chapter II

ANNOUNCEMENT OF APPLICATION AND ISSUANCE OF GOOD MANUFACTURING PRACTICES FOR THE PRODUCTION OF DRUGS AND DRUG SUBSTANCES

Article 3. Documentation on Principles and Standards of Good Manufacturing Practices

1. Announce the application of the following principles and standards of good manufacturing practices:

a) The principles and standards of Good Manufacturing Practices for drugs and drug substances of WHO specified in Appendix I attached hereto and updated documents as provided for in Clause 4 of this Article;

b) The principles and standards of Good Manufacturing Practices for biological products derived from human blood and plasma of WHO specified in Appendix II attached hereto and updated documents as provided for in Clause 4 of this Article;

c) The principles and standards of Good Manufacturing Practices of the Pharmaceutical Inspection Cooperation Scheme specified in Appendix III attached hereto and updated documents as provided for in Clause 4 of this Article;

d) The principles and standards of Good Manufacturing Practices of the European Union specified in Appendix IV attached hereto and updated documents as provided for in Clause 4 of this Article.

2. Issue the following principles and standards of good manufacturing practices:

a) The principles and standards of Good Manufacturing Practices for herbal medicines specified in Appendix V attached hereto;

b) The principles and standards of Good Manufacturing Practices for traditional medicines specified in Appendix VI attached hereto;

c) The principles and standards of Good Manufacturing Practices for traditional medicine ingredients specified in Appendix VII attached hereto.

3. Application of other GMP principles and standards:

a) For facilities producing drugs and drug substances that are not excipients:

In addition to the GMP principles and standards specified in Clauses 1 and 2 of this Article, other GMP principles and standards applied include:

- Other GMP principles and standards equivalent to the EU-GMP principles and standards issued by strict regulatory authorities in SRA countries may be applied. Facilities producing drugs and drug substances applying these principles and standards shall be responsible for providing the English version issued by the strict regulatory authority to the Department of Medicines Administration for posting on the Ministry of Health's website and the Department of Medicines Administration's website;

- GMP principles and standards that have been evaluated and recognized as consistent with the GMP principles and standards issued by the Minister of Health or announced for application pursuant to point c, Clause 1, Article 97 of Decree No. 163/2025/NĐ-CP dated June 29, 2025 detailing certain provisions and measures to organize and guide the implementation of the Medicine Law (hereinafter referred to as Decree No. 163/2025/NĐ-CP) may be used in evaluating the compliance with GMP of foreign drug and drug substance production facilities when registering for circulation in Vietnam.

b) For facilities producing drug substances that are excipients:

In addition to the principles and standards of Good Manufacturing Practice (GMP) prescribed in Clause 1 of this Article, the excipient manufacturing facility shall apply other GMP principles and standards of the International Pharmaceutical Excipients Council (IPEC), The Certification Scheme for Pharmaceutical Excipients (EXCiPACT), American National Standards Institute (ANSI), United States Pharmacopeia (USP), or other production principles and standards for excipients used in the manufacture of drugs, cosmetics, and food products that have been adopted by relevant regulatory authorities of countries or international organizations.

4. Updated GMP Principles and Standards Documents:

a) In case the World Health Organization (WHO) amends or supplements the GMP principles and standards (hereinafter referred to as updated documents) prescribed in Points a and b of Clause 1 of this Article, within three months from the date of publication of the updated documents on the WHO's website, the Department of Drug Management or the Department of Traditional Medicine Management, depending on the assigned state management sector, shall publish the content of the updated documents for related parties to search, update, and apply; organize the translation and publish the Vietnamese version (for reference) on the Ministry of Health's website, the Department of Drug Management's website, and the Department of Traditional Medicine Management's website.

b) In case the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or the European Union has updated documents prescribed in Points c and d of Clause 1 of this Article, which have not yet been posted on the Ministry of Health's website or the Department of Drug Management's website, the drug manufacturing facilities and raw material manufacturing facilities shall implement the application of these GMP principles and standards and be responsible for providing the English version to the Department of Drug Management. Within ten days from the date of receipt, the Department of Drug Management shall post the English version on the Ministry of Health's website and the Department of Drug Management's website for related parties to search, update, and apply.

Article 4. Application of GMP Principles and Standards

1. Drug manufacturing facilities and raw material manufacturing facilities (excluding biological drugs derived from human blood and plasma) shall implement the application of GMP as prescribed in Appendix I or Appendix III or Appendix IV issued together with this Circular and the updated documents as stipulated in Clause 4 of Article 3 of this Circular.

2. Drug manufacturing facilities and raw material manufacturing facilities producing biological drugs derived from human blood and plasma shall implement the application of GMP as prescribed in Appendix II issued together with this Circular and the updated documents as stipulated in Clause 4 of Article 3 of this Circular.

3. Drug manufacturing facilities and raw material manufacturing facilities using medicinal herbs shall implement the application of GMP principles and standards as prescribed in Appendix V issued together with this Circular.

4. Traditional medicine manufacturing facilities that only produce traditional medicines in the form of decoctions, powders, pills, granules, medicinal alcohol, medicinal spirits shall implement the application of GMP principles and standards as prescribed in Part I of Appendix VI issued together with this Circular.

5. Traditional medicine manufacturing facilities that produce modern dosage forms (capsules, tablets, granules, syrups, and other modern dosage forms) not covered by the provisions of Clause 4 of this Article shall implement the application of GMP as prescribed in Part II of Appendix VI issued together with this Circular.

6. Traditional herbal medicine manufacturing facilities shall implement the application of GMP as prescribed in Appendix VII issued together with this Circular.

7. Drug manufacturing facilities and raw material manufacturing facilities shall implement the application of other GMP principles and standards equivalent to EU-GMP, issued by the drug regulatory authorities of SRA countries and the updated documents as stipulated in Clause 4 of Article 3 of this Circular.

8. Medicinal herb manufacturing facilities, traditional medicine manufacturing facilities, and traditional herbal medicine manufacturing facilities shall implement the application of GMP principles and standards as prescribed in Appendix I or Appendix III or Appendix IV issued together with this Circular and the updated documents as stipulated in Clause 4 of Article 3 of this Circular.

9. Traditional medicine manufacturing facilities and traditional herbal medicine manufacturing facilities permitted to implement the application of GMP principles and standards as prescribed in Part II of Appendix VI or Appendix I or Appendix III or Appendix IV or Appendix V issued together with this Circular and the updated documents as stipulated in Clause 4 of Article 3 of this Circular.

10. The implementation of GMP principles and standards for high-risk drugs shall be carried out according to specific regulations as follows:

a) Drugs and raw materials containing beta-lactam antibiotics (Penicillins, Cephalosporins, Penems, and similar), cytotoxic drugs, hormone contraceptives, vaccines, biological products containing live microorganisms, and specific drugs requiring separate production as specified in GMP principles and standards (WHO-GMP, PIC/S-GMP, EU-GMP, and equivalents of EU-GMP), in addition to being produced at facilities implementing corresponding GMP principles and standards as prescribed in this Article, must also be produced on separate production lines (separate factories, production equipment) and measures to prevent contamination and cross-contamination of the environment and other drugs produced in the same area must be ensured.

b) For anti-cancer drugs, sex hormones, and potent drugs not included in the drugs specified in Point a of this Clause, the determination of the necessity and degree of separation regarding facilities (facilities) and/or production equipment shall be based on risk assessment and guidance from the European Medicines Agency (EMA) or WHO.

c) Drugs and raw materials specified in Points a and b of this Clause, when manufactured at overseas facilities as prescribed in Point b of Clause 1 of Article 94 of Decree No. 163/2025/NĐ-CP, and simultaneously approved for circulation or granted Product Certificate (CPP) by the regulatory authorities of those countries, shall be recognized within the scope of GMP certification without the requirement to be produced on separate production lines and shall be announced within the scope of production activities already evaluated by the manufacturing facility according to Article 17 of this Circular.

11. A chemical drug production facility includes both prescription and over-the-counter chemical drugs with a production line for soft capsules, liquid oral medications, and topical medications (creams, gels, ointments, and liquid topical medications). Such facilities produce prescription chemical drugs, over-the-counter chemical drugs, and herbal extracts in the form of powders, granules, decoctions, essential oils, and standardized herbal powders on corresponding production lines. The facility must implement and apply Good Manufacturing Practice (GMP) principles and standards as stipulated in Appendix I, Appendix III, or Appendix IV issued together with this Circular and updated materials as provided for in Clause 4, Article 3 of this Circular.

12. A facility that only produces over-the-counter chemical drugs shall produce herbal medicines, traditional medicines, and health food supplements in forms certified. The facility must implement and apply GMP principles and standards as stipulated in Appendix I, Appendix III, or Appendix IV issued together with this Circular and updated materials as provided for in Clause 4, Article 3 of this Circular.

13. An herbal medicine production facility shall produce herbal medicines supplemented with purified components extracted from essential oils, vitamins, and minerals and must implement and apply GMP principles and standards as stipulated in Appendix V issued together with this Circular.

14. A traditional medicine production facility shall produce traditional medicines supplemented with purified components extracted from essential oils, vitamins, and minerals and must implement and apply GMP principles and standards as stipulated in Appendix VI issued together with this Circular.

15. An herbal medicine and traditional medicine production facility shall produce health food supplements in forms certified and must implement and apply corresponding GMP principles and standards as stipulated in Clauses 1, 8, and 9 of this Article.

16. A facility producing raw materials and semi-finished products of herbs in the form of decoctions, granules, powders, extracts, essential oils, resins, gums, and jellies shall produce raw materials and semi-finished products of health food supplements in forms certified and must implement and apply corresponding GMP principles and standards as stipulated in Clauses 8 and 9 of this Article.

17. A facility with a dedicated production line for biological drug ingredients containing probiotics shall produce raw materials and health food supplements containing the same type of probiotics in forms certified and must implement and apply corresponding GMP principles and standards as stipulated in Clause 1 of this Article.

18. A facility that performs one or more stages of the drug production process must implement and comply with GMP according to the relevant requirements corresponding to the drug production stages specified in Clauses 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 of this Article.

19. A drug and raw material production facility must implement and apply updated GMP documents as stipulated in Clause 4, Article 3 of this Circular within the following timeframes:

a) 12 months for cases requiring changes to the factory premises or production equipment, starting from the date the updated documents are published on the Ministry of Health's website and the Drug Administration of Vietnam's website;

b) 6 months for updates not covered under point a of this clause, starting from the date the updated documents are published on the Ministry of Health's website and the Drug Administration of Vietnam's website.

20. A facility producing excipients as raw materials must implement and apply GMP principles and standards as stipulated in Part IV of Appendix I issued together with this Circular or other GMP principles and standards as stipulated in Clause 3, Article 3 of this Circular and updated materials as provided for in Clause 4, Article 3 of this Circular. In cases where the WHO, IPEC, EXCiPACT, ANSI, USP, or other relevant international organizations have published updates or amendments to GMP principles and standards for excipient raw materials used in drug, cosmetic, and food production (hereinafter referred to as updated documents) on their websites, the excipient raw material production facility must implement and apply the updated GMP documents within the following timeframe:

a) 12 months for cases requiring changes to the factory premises or production equipment, starting from the date the updated documents are published;

b) 6 months for updates not covered under the case specified in point a of this clause, starting from the date the updated documents are published.

Chapter III

EVALUATION OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICE FOR ISSUING THE LICENSE TO OPERATE AS A DRUG BUSINESS FOR DRUG AND RAW MATERIAL PRODUCTION FACILITIES

Article 5. Documents serving as the basis for evaluating compliance with Good Manufacturing Practices (GMP)

1. The documents serving as the basis for evaluating compliance with GMP for pharmaceutical business establishments are the documents submitted by the pharmaceutical business establishment when requesting issuance of a Certificate of Compliance with Pharmaceutical Business Conditions pursuant to Clause 1 of Article 38 of the Pharmacy Law, specifically:

a) Documents stipulated in Clause 1 and Point a of Clause 2 of Article 20 of Decree No. 163/2025/NĐ-CP;

b) Documents stipulated in Point a of this Clause and documents stipulated in Point a of Clause 1 of Article 37 of Decree No. 163/2025/NĐ-CP for pharmaceutical production facilities that require special supervision;

c) Technical documents on the production facility stipulated in Point a of Clause 2 of Article 20 of Decree No. 163/2025/NĐ-CP presented according to the guidance on the overall dossier of the production facility prescribed in Appendix VIII attached to this Circular, or the updated overall dossier in case of expansion of scope of activities.

2. In cases where a production facility requests issuance of both a GMP Certificate and a Certificate of Compliance with Pharmaceutical Business Conditions, the production facility must clearly state this in the Application for Issuance of Certificate of Compliance with Pharmaceutical Business Conditions.

3. In cases where a production facility requests issuance of a Certificate of Compliance with Pharmaceutical Business Conditions with a scope of manufacturing pharmaceutical products, raw materials for pharmaceutical products, selling pharmaceutical products, raw materials for pharmaceutical products to wholesale, retail establishments, medical examination and treatment facilities, additional technical and personnel documents must be provided according to the principles of Good Distribution Practice (GDP) for pharmaceutical products and raw materials for pharmaceutical products as stipulated in Point c of Clause 2 of Article 20 of Decree No. 163/2025/NĐ-CP. The receiving agency will simultaneously evaluate compliance with GDP when assessing compliance with GMP of the facility according to relevant laws on GDP. If the production facility delivers pharmaceutical products, raw materials for pharmaceutical products from its own warehouse, it does not need to submit technical and personnel documents according to the aforementioned GDP principles.

Article 6. Procedure for Evaluating Compliance with Good Manufacturing Practices for Pharmaceutical Products and Raw Materials for Pharmaceutical Products

1. Receiving documents: The production facility directly submits or through postal service or online 01 (one) set of documents as prescribed in Article 5 of this Circular along with the standardization fee as prescribed by the Minister of Finance for standardization fees and conditions for production to the receiving agency of the Ministry of Health as follows:

a) The Traditional Medicine Management Department for production facilities requesting issuance of a Certificate of Compliance with Pharmaceutical Business Conditions with a scope limited to producing traditional herbal medicines, traditional drugs, traditional medicinal ingredients at the time of submitting the application;

b) The Pharmaceutical Management Department for production facilities requesting issuance of a Certificate of Compliance with Pharmaceutical Business Conditions with a scope limited to producing raw materials for pharmaceutical products (excluding herbal medicines), chemical drugs, herbal drug preparations, vaccines, biological products at the time of submitting the application;

c) The Pharmaceutical Management Department for production facilities requesting issuance of a Certificate of Compliance with Pharmaceutical Business Conditions with a scope concurrently producing one of the pharmaceutical products or raw materials for pharmaceutical products specified in Point a of this Clause and one of the pharmaceutical products or raw materials for pharmaceutical products specified in Point b of this Clause at the time of submitting the application.

2. Procedure for receiving and processing documents:

a) Upon receipt of complete documents as prescribed in Clause 1 of Article 5 of this Circular, the receiving agency issues to the applicant a Document Receipt Form according to Model No. 01 in Appendix I issued together with Decree No. 163/2025/NĐ-CP;

b) Within 05 working days from the date of receipt of valid documents, the receiving agency establishes an Evaluation Team and sends to the production facility a decision establishing the Evaluation Team, including a proposed schedule for on-site evaluation at the production facility;

c) Within 07 working days from the date of issuance of the decision establishing the team and within 03 working days for production facilities producing pharmaceutical products or raw materials for pharmaceutical products prioritized under administrative procedures as stipulated in Clause 5 of Article 7 of the Pharmacy Law, the Evaluation Team conducts on-site evaluation at the production facility.

Article 7. Procedure for assessing compliance and classifying compliance with Good Manufacturing Practices (GMP)

1. Documents used in the assessment of GMP compliance: The principle and standard documents of WHO-GMP or the principle and standard documents of GMP as stipulated in Points a and b of Clause 1 and Clause 2 of Article 3 of this Circular, corresponding to the production activities of the manufacturing facility.

2. On-site evaluation procedure at the manufacturing facility:

a) Step 1. The evaluation team announces the Decision on the establishment of the Evaluation Team, its purpose, content, and the planned evaluation program at the manufacturing facility.

b) Step 2. The manufacturing facility presents a summary of its organizational structure, personnel, and implementation and application of GMP or specific content according to the evaluation period.

c) Step 3. The evaluation team conducts an on-site assessment of the implementation and application of GMP at the manufacturing facility according to specific content. In cases where the facility performs one or several stages of the production process, the assessment content will only include requirements corresponding to one or several production stages that the facility implements. The evaluation program may be adjusted based on the actual implementation situation or issues discovered during the evaluation process.

d) Step 4. The evaluation team meets with the manufacturing facility to inform about issues identified during the evaluation process (if any); assess the severity of each issue; discuss with the manufacturing facility if it does not agree with the evaluation team's assessment of each issue or regarding the level of compliance with GMP principles and standards of the manufacturing facility.

e) Step 5. Drafting and signing the evaluation report: After reaching consensus with the facility, the evaluation team drafts the evaluation report according to Model No. 03 stipulated in Appendix X issued together with this Circular. The evaluation report must reflect the composition of the evaluation team, the composition of the manufacturing facility, location, time, scope, form of evaluation, unresolved issues between the evaluation team and the manufacturing facility (if any). The head of the manufacturing facility and the leader of the evaluation team sign to confirm the evaluation report. Two copies of the report are made, one copy retained at the manufacturing facility, and one copy retained at the Receiving Authority.

f) Step 6. Completing the GMP Evaluation Report: Within five working days from the date of signing the evaluation report, the evaluation team is responsible for drafting the GMP evaluation report according to Model No. 04 stipulated in Appendix X issued together with this Circular and sending it to the manufacturing facility. The GMP evaluation report must list and analyze, classify the severity of issues that the manufacturing facility needs to address and correct; refer to relevant legal provisions and GMP principles and standards, evaluate the level of GMP compliance of the manufacturing facility. The classification of the severity of issues and the evaluation of the level of GMP compliance of the manufacturing facility (specifically for each production line) are stipulated in Appendix IX issued together with this Circular. Two copies of the GMP evaluation report are made, one copy sent to the manufacturing facility, and one copy retained at the Receiving Authority.

3. Level of GMP Compliance: The level of GMP compliance of the manufacturing facility is defined in Appendix IX issued together with this Circular, including the following levels:

a) The manufacturing facility complies with GMP at Level 1.

b) The manufacturing facility complies with GMP at Level 2.

c) The manufacturing facility complies with GMP at Level 3.

d) The manufacturing facility complies with GMP at Level 4.

Article 8. Handling the Results of Good Manufacturing Practice (GMP) Compliance Assessment

1. In case the GMP assessment report concludes that the production facility complies with GMP at level 1 as stipulated in point a, Clause 3, Article 7 of this Circular:

a) Within seven working days from the date of completing the GMP assessment report, the Receiving Authority shall submit to the Minister of Health for issuance of the Business Registration Certificate for Drug Trading Conditions according to Form No. 13 attached in Appendix I promulgated by Decree No. 163/2025/NĐ-CP and issue the GMP Certificate according to Form No. 05 attached in Appendix X of this Circular if the production facility requests it.

b) The scope of production activities recorded on the Business Registration Certificate for Drug Trading Conditions of the production facility shall be determined based on each production line that has been assessed as complying with GMP.

2. In case the GMP assessment report concludes that the production facility complies with GMP at level 2 as stipulated in point b, Clause 3, Article 7 of this Circular:

a) Within five working days from the date of completing the GMP assessment report, the Receiving Authority shall issue a written notice requesting the production facility to implement corrective actions and repairs for the deficiencies identified according to Form No. 16 attached in Appendix I promulgated by Decree No. 163/2025/NĐ-CP along with the GMP assessment report sent to the production facility.

b) After completing the corrective actions and repairs, the production facility must submit a written report on the corrective actions and repairs including the plan and evidence proving (documentary files, images, videos, certificates or other proof documents).

c) Within twenty days from the date of receiving the production facility's report on the completion of corrective actions and repairs, the Receiving Authority shall evaluate the results of the corrective actions and repairs of the production facility according to the documents specified in Clause 1, Article 7 of this Circular, prepare a report on the corrective actions and repairs of the production facility, and conclude on the compliance status of GMP of the production facility: - The Receiving Authority shall submit to the Minister of Health for issuance of the Business Registration Certificate for Drug Trading Conditions and issue the GMP Certificate (if requested by the production facility) according to Form No. 05 prescribed in Appendix X of this Circular in case the corrective actions of the production facility have met the requirements and concluded that the production facility complies with GMP; - The Receiving Authority shall issue a written notice to the production facility specifying the reasons in case the conclusion is that the production facility does not comply with GMP.

d) Within six months from the date the Receiving Authority sends the GMP assessment report containing the requirement for corrective actions and repairs, the production facility must submit a written report on the corrective actions and repairs according to point b, Clause 2 of this Article. If the production facility fails to submit the report on corrective actions and repairs beyond this period or if the Receiving Authority concludes that the production facility does not comply with GMP within twelve months from the date of submitting the initial application, then the submitted application will lose its validity.

3. In case the GMP assessment report concludes that the production facility complies with GMP at level 3 as stipulated in point c, Clause 3, Article 7 of this Circular:

a) The handling procedures and time limits for the GMP compliance assessment results shall be carried out according to Clause 2 of this Article;

b) Within twenty days from the date of receiving the production facility's report on corrective actions and repairs, the Receiving Authority shall conduct an on-site evaluation of the corrective actions and repairs at the production facility and conclude on the compliance status of GMP of the production facility according to Clause 2, Article 7 of this Circular.

4. In case the GMP assessment report concludes that the production facility complies with GMP at level 4 as stipulated in point d, Clause 3, Article 7 of this Circular: Within five working days from the date of completing the GMP assessment report, the Receiving Authority shall issue a written notice regarding the non-compliance with GMP of the production facility according to Form No. 16 attached in Appendix I promulgated by Decree No. 163/2025/NĐ-CP along with the GMP assessment report sent to the production facility and shall not issue the Business Registration Certificate for Drug Trading Conditions.

5. In case the production facility disagrees with the deficiencies identified in the GMP assessment report, within thirty days from the date of completing the GMP assessment report or the corrective action assessment report, the production facility shall submit a written request to the Receiving Authority accompanied by evidence (documentary files, images, videos, certificates) related to the deficiencies. Within ten days from the date of receiving the production facility's written request, the Receiving Authority shall review the GMP assessment report, the content of the production facility's request, seek expert opinions if necessary, and issue a written response to the production facility. The response must clearly state whether the request is accepted or rejected, and the reasons for rejection. This period is not included in the assessment deadline.

6. Within five working days from the date of issuing the Business Registration Certificate for Drug Trading Conditions, the Receiving Authority shall publish on the Ministry of Health's electronic portal and the Receiving Authority's website the following information:

a) Name and address of the production facility;

b) Full name of the person responsible for drug specialty and the person in charge of quality assurance along with their Drug Practitioner Certificate number;

c) Number of the Business Registration Certificate for Drug Trading Conditions;

d) Scope of drug trading (scope of production activities);

đ) Number of the GMP Certificate (if applicable);

e) Expiry date of the GMP compliance assessment.

Chapter IV

ASSESSMENT OF THE MAINTENANCE OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICE FOR DRUGS AND DRUG SUBSTANCES

Article 9. Periodic Evaluation of Compliance with Good Manufacturing Practices (GMP)

1. The periodic evaluation cycle for compliance with GMP at production facilities is three years, starting from the date of signing the inspection report of the previous evaluation (excluding any unscheduled inspections, audits, or checks conducted by the Ministry of Health or Provincial Health Departments).

2. In November each year, the Receiving Agency reviews and issues a plan for the periodic evaluation of compliance with GMP for production facilities for the following year. The plan for the periodic evaluation of compliance with GMP is published on the Receiving Agency's website. For production facilities specified in Clause 3, Article 6 of this Circular, the Drug Administration of Vietnam will publish and implement the plan for the periodic evaluation of compliance with GMP and Good Distribution Practices (GDP) if requested by the facility.

3. At least thirty days prior to the scheduled periodic evaluation date announced by the Receiving Agency, the production facility must submit to the Receiving Agency a report on its pharmaceutical manufacturing activities and maintenance of GMP standards (hereinafter referred to as the activity-compliance report) according to Form No. 2 stipulated in Appendix X attached to this Circular, along with updated technical documentation regarding the facility’s physical conditions, technology, and personnel (if there have been changes). For example, if the scheduled periodic evaluation at Facility A is set for August 18, 2018, then Facility A must submit its activity-compliance report to the Receiving Agency before July 18, 2018.

4. If a production facility fails to submit the activity-compliance report within the time frame specified in Clause 3 of this Article, the Receiving Agency will issue a notice requesting the facility to submit the report within fifteen days from the due date.

5. Within forty-five days from the issuance of the notice by the Receiving Agency, the production facility must submit the activity-compliance report along with an explanation for the delay. Should the facility fail to submit the report after this period, the Receiving Agency will conduct an unscheduled inspection, audit, or check of the facility's compliance with GMP as stipulated in Article 12 of this Circular.

6. After submitting the activity-compliance report as required, the production facility may continue its pharmaceutical manufacturing activities in accordance with the provisions of the Drug Law, related guidance documents, and within the scope of operations stated in the issued Pharmaceutical Business License, except where there is a management authority decision regarding non-compliance with GMP. The facility must ensure ongoing compliance with GMP during operations. Upon request, the Receiving Agency will confirm the submission status of the activity-compliance report.

7. The procedures for evaluation, evaluation process, and classification of GMP compliance results shall be carried out in accordance with the provisions of Articles 6 and 7 of this Circular.

8. In cases of disease outbreaks, natural disasters, catastrophes, or war that restrict the movement of the Receiving Agency and prevent it from conducting the required periodic evaluations of GMP compliance, the Receiving Agency shall take the following actions:

a) Issue a GMP Certificate upon application by the production facility to meet the export requirements for pharmaceuticals and drug ingredients;

b) Conduct remote evaluations for sterile drug and biological product production facilities, or for facilities that last met levels 3 and 4 of GMP compliance;

c) Once the disaster situation has been resolved, the Receiving Agency will conduct the periodic evaluation of GMP compliance as stipulated in Articles 6 and 7 of this Circular.

Article 10. Handling the results of periodic assessment of compliance with Good Manufacturing Practice (GMP)

1. In case the GMP assessment report concludes that the production facility complies with GMP at level 1 as stipulated in point a, Clause 3, Article 7 of this Circular:

a) Within ten days from the date of completing the GMP assessment report, the Receiving Agency shall update information on the maintenance of GMP compliance of the facility on the Ministry of Health's Electronic Information Portal, the Receiving Agency's Electronic Information Page as prescribed in Clause 6, Article 8 of this Circular, and issue the GMP Certificate according to Form No. 05 attached as Appendix X of this Circular for the facility requesting issuance of the GMP Certificate;

b) In case the production facility ceases one or more activities within the scope of business as recorded on the Business Condition Compliance Certificate, the Receiving Agency shall update information on the maintenance of GMP compliance for the assessed production activities and issue a written notice requiring the production facility to adjust the Business Condition Compliance Certificate according to Point b, Clause 3, Article 36 of the Drug Law.

2. In case the GMP assessment report concludes that the production facility complies with GMP at level 2 as stipulated in point b, Clause 3, Article 7 of this Circular:

a) Within five working days from the date of completing the GMP assessment report, the Receiving Agency shall issue a written notice requiring the production facility to implement corrective actions and repairs for deficiencies identified according to Form No. 16 issued together with Decree No. 163/2025/NĐ-CP, along with the GMP assessment report sent to the production facility for implementation of corrective actions and repairs, and submit a corrective action report to the Receiving Agency;

b) Within forty-five days from the date the Receiving Agency sends the GMP assessment report, the production facility must submit a corrective action report including a plan and evidence (document files, images, videos, certificates, or other proof) of the corrective actions and repairs recorded in the GMP assessment report;

c) Within twenty days from the date of receiving the corrective action report, the Receiving Agency shall evaluate the results of the corrective actions by the production facility and conclude on the GMP compliance status of the production facility: - If the corrective actions by the production facility meet the requirements, the Receiving Agency shall update information on the maintenance of GMP compliance of the facility on the Ministry of Health's Electronic Information Portal, the Receiving Agency's Electronic Information Page as prescribed in Clause 6, Article 8 of this Circular, and issue the GMP Certificate according to Form No. 05 attached as Appendix X of this Circular for the facility requesting issuance of the GMP Certificate; - If the corrective actions by the production facility do not meet the requirements, the Receiving Agency shall issue a written notice specifying the continued corrective actions and repairs required and submission of supplementary reports. The extended period for continued corrective actions and repairs and reporting is forty-five days from the date of the request notice.

d) Within one hundred thirty-five days from the date of completing the GMP assessment report if the production facility does not submit a corrective action report or if the corrective actions still do not meet the requirements after the provisions in Point c of this Clause, the Receiving Agency shall issue a notice of non-compliance with GMP and, depending on the nature and severity of the violation, the Receiving Agency shall implement one or more measures as prescribed in Points a and b of Clause 4 of this Article.

3. In case the GMP assessment report concludes that the production facility complies with GMP at Level 3 as prescribed in Point c, Clause 3, Article 7 of this Circular: The procedures and time limits for handling the results of the GMP compliance assessment shall be carried out as prescribed in Clause 2 of this Article. Within twenty days from the date of receiving the corrective action report, the Receiving Agency shall conduct an on-site evaluation of the corrective actions at the production facility before concluding on the GMP compliance status of the production facility as prescribed in Point c, Clause 2 of this Article.

4. In case the GMP assessment report concludes that the production facility complies with GMP at Level 4 as prescribed in Point d, Clause 3, Article 7 of this Circular: Within five working days from the date of signing the assessment record, based on the risk assessment of deficiencies discovered concerning drug quality, raw materials for drugs, and user safety, the Receiving Agency shall issue a notice of non-compliance with GMP accompanied by the GMP assessment report. Depending on the nature and severity of the violation, the Receiving Agency shall implement one or more of the following measures:

a) Issue a temporary suspension of operations notice for the production facility; Administrative penalty or transfer to the competent authority for administrative penalty according to the law on administrative violations;

b) Request the Minister of Health to issue a decision to revoke the Business Condition Compliance Certificate already issued according to Clause 2, Article 40 of the Drug Law in cases where the facility has not implemented corrective actions and repairs after the suspension period has expired;

c) In case the production facility does not comply with one or more activities within the scope of business as recorded on the Business Condition Compliance Certificate already issued, the Receiving Agency: - Shall issue a temporary suspension of operations notice for the production facility for the violated scope; Administrative penalty or transfer to the competent authority for administrative penalty according to the law on administrative violations; - Request the Minister of Health to issue a decision to revoke the Business Condition Compliance Certificate already issued to remove the non-compliant business scope according to Article 40 of the Drug Law in cases where the facility has not implemented corrective actions and repairs related to the violated scope after the suspension period has expired, while issuing a new Business Condition Compliance Certificate suitable for the compliant business scope of the production facility;

d) Revoke the GMP Certificate (if any) and issue a new GMP Certificate suitable for the scope that the production facility complies with if the facility requests.

5. Within five working days from the date of the conclusion that the production facility meets the requirements for maintaining Good Manufacturing Practice (GMP) or from the date of issuance of the Decision revoking the Certificate of Eligibility to Operate a Pharmaceutical Business due to the production facility's failure to maintain compliance with GMP, the Receiving Authority shall update the status of GMP compliance on its electronic information website in accordance with the provisions set forth in Clause 6, Article 8 of this Circular for production facilities that meet GMP requirements or provide information about the revocation of the Certificate of Eligibility to Operate a Pharmaceutical Business and the GMP Certificate (if issued) for production facilities that fail to maintain compliance with GMP.

6. In cases where samples of drugs or drug ingredients collected during the evaluation process are found to violate quality standards, the Receiving Authority shall handle such non-compliant drugs or drug ingredients in accordance with current regulations.

Article 11. Change Control

1. A vaccine production facility must submit a notification letter accompanied by an assessment of the risks and impacts of proposed changes on product quality and safety before implementing any changes as specified in Point a and b of this clause.

a) As provided in Points d, đ, e, and g of Clause 2 of this Article;

b) Producing vaccines or conducting trial production of vaccines or other pharmaceutical products on a vaccine production line that has been certified; within fifteen days, the Department of Medicines Administration shall issue a written response if it disagrees with the proposed change by the vaccine production facility.

2. After implementing changes, a production facility must apply for a new Certificate of Eligibility to Operate a Pharmaceutical Business or submit a change report using Form No. 06 as stipulated in Appendix X attached to this Circular if it falls under any of the following circumstances:

a) Changes as provided in Point b of Article 36 of the Drug Law;

b) Changing the location of the manufacturing plant at the same business site;

c) Adding a new manufacturing plant at a different location within the same business site;

d) Expanding the manufacturing plant or making significant changes to the structure and layout of one or more production lines or the entire plant based on the existing plant structure;

đ) Repairing or changing the structure and layout of part of a production line, thereby altering the production environment conditions and production processes;

e) Changing major production equipment that affects the production process and the quality of drugs or drug ingredients;

g) Modifying auxiliary systems or changing the design principle and operation of utility systems that affect the production environment;

h) The production facility switching between the scope of producing chemical drugs including prescription chemical drugs and the scope of only producing over-the-counter chemical drugs.

3. If a production facility undergoes changes as provided in Point a of Clause 2 of this Article, the facility must submit an application for a Certificate of Eligibility to Operate a Pharmaceutical Business in accordance with Clauses 2 and 4 of Article 38 of the Drug Law. The procedures for evaluating GMP compliance, classifying results, and handling GMP compliance assessment outcomes are carried out in accordance with Articles 6, 7, and 8 of this Circular.

4. If a production facility undergoes changes as provided in Points b, c, or d of Clause 2 of this Article or if a sterile drug or drug ingredient production facility undergoes changes as provided in Points đ, e, and g of Clause 2 of this Article, the facility must submit a change report along with corresponding technical documentation to the Receiving Authority.

a) The Receiving Authority conducts an on-site evaluation at the production facility. If the facility meets the requirements, the Receiving Authority issues a written agreement with the facility's changes;

b) The procedures for evaluating, classifying results, and handling evaluation outcomes for production facilities undergoing changes as provided in Point b of Clause 2 of this Article are carried out in accordance with Articles 6, 7, and 10 of this Circular;

c) The procedures for evaluating, classifying results, and handling evaluation outcomes for production facilities undergoing changes as provided in Point c or d of Clause 2 of this Article or for sterile drug or drug ingredient production facilities undergoing changes as provided in Points đ, e, and g of Clause 2 of this Article are carried out in accordance with Articles 6, 7, and 8 of this Circular.

5. If a drug or drug ingredient production facility undergoes changes as provided in Points đ, e, or g of Clause 2 of this Article (excluding the circumstances provided in Clause 4 of this Article), the facility must submit a change report along with corresponding technical documentation to the Receiving Authority. The facility must continue to ensure ongoing compliance with GMP principles and standards. The Receiving Authority will conduct an unannounced inspection and handle the evaluation outcome according to Article 12 of this Circular if the change report does not adequately demonstrate continued GMP compliance at the facility.

6. If a drug or drug ingredient production facility undergoes changes as provided in Point h of Clause 2 of this Article, the facility must follow the procedures for adjusting the Certificate of Eligibility to Operate a Pharmaceutical Business as stipulated in Clause 1 of Article 20 of Decree No. 163/2025/NĐ-CP;

7. If a production facility is evaluated as meeting EU-GMP or equivalent EU-GMP standards by one of the stringent drug regulatory authorities (SRA) or a drug regulatory authority recognized by the Ministry of Health based on WHO classification and requests publication on the Receiving Authority’s electronic information website:

a) The production facility must submit a request for publication along with the GMP Certificate or a conclusion document stating that the facility meets EU-GMP or equivalent EU-GMP standards and a GMP inspection report issued by a stringent drug regulatory authority (SRA) or a drug regulatory authority recognized by the Ministry of Health based on WHO classification.

b) Within fifteen days from the date of receiving the application file, the Receiving Agency shall review the application file and compare it with the information on production activities within the scope of certification recorded on the Certificate of Compliance for Drug Business Conditions of the production facility and published on the Ministry of Health's Electronic Portal and the Receiving Agency's Electronic Information Website. The published information includes: - Name and address of the production facility (the address of the factory/production line being evaluated); - Number of the EU-GMP certificate or equivalent EU-GMP certificate or conclusion document stating that the facility meets EU-GMP or equivalent standards; validity period and issuing authority of the certificate; - Scope of production activities already assessed corresponding to the GMP certificate.

Article 12. Sudden Assessment and Inspection of Compliance with Good Manufacturing Practices

1. The inspection work to ensure compliance with GMP at production facilities shall be carried out in accordance with the provisions of the law.

2. The Receiving Agency shall conduct sudden assessments of compliance with GMP at production facilities when such facilities fall under any of the following circumstances:

a) The production facility has not yet addressed the requirements stipulated in paragraph 2, point c, Clause 6, Article 11 of this Circular;

b) A production facility that complies with GMP at level 3 or level 4 as prescribed in point c and d, Clause 3, Article 7 of this Circular must undergo at least one sudden assessment within three years from the end date of the previous assessment period;

c) The production facility has one batch of drugs recalled due to violation at level 1;

d) The production facility has drugs causing serious adverse reactions or a chain of harmful reactions (ADR) reported by the National Center for Medicines Information and Adverse Reaction Monitoring, including serious adverse reactions directly affecting drug quality, safety, and efficacy;

đ) The production facility has inspection results concluded by competent authorities indicating serious violations of GMP principles and standards;

e) In cases where there is information reflecting or reporting serious violations of GMP principles and standards by the facility;

g) The production facility fails to submit the operational report - maintaining compliance with GMP as prescribed in Clause 5, Article 9 of this Circular;

h) The chemical pharmaceutical production facility does not issue prescriptions when implementing activities of producing herbal medicines, traditional medicines, or health supplements.

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

4. The procedure for conducting sudden assessments at production facilities shall be carried out in accordance with the provisions of Article 7 of this Circular.

5. The handling of inspection and sudden assessment results at production facilities shall be conducted in accordance with the provisions of the law.

Article 13. Assessment of Compliance and Maintenance of Compliance with Good Manufacturing Practices for Domestic Production Facilities of Drugs and Raw Materials for Drugs Not Subject to Issuance of Certificates of Compliance for Drug Business Conditions

1. Production facilities not subject to issuance of Certificates of Compliance for Drug Business Conditions (facilities engaged in drug activities but not for commercial purposes) must comply with GMP as stipulated in point a, Clause 2, Article 35 of the Drug Law.

2. Production facilities not subject to issuance of Certificates of Compliance for Drug Business Conditions (excluding the compounding units of medical examination and treatment facilities) shall submit an application for GMP compliance assessment according to Form No. 1 prescribed in Appendix X issued together with this Circular and technical documentation about the drug production facility presented in accordance with the overall dossier guidelines of the production facility prescribed in Appendix VIII issued together with this Circular for initial assessment or a report on production activities - maintaining compliance with GMP of the facility, accompanied by updated technical documentation about the production facility (if there have been changes) as prescribed in Clause 3, Article 9 for periodic assessment.

3. The procedures for assessment, assessment process, classification of assessment results, change control, and sudden assessment of GMP compliance for production facilities of drugs and raw materials for drugs not subject to issuance of Certificates of Compliance for Drug Business Conditions shall be implemented in accordance with the corresponding provisions of Articles 6, 7, 9, 11, and 12 of this Circular.

4. Handling of initial assessment results of GMP compliance for production facilities of drugs and raw materials for drugs not subject to issuance of Certificates of Compliance for Drug Business Conditions:

a) The procedures and time limits for handling initial assessment results of GMP compliance of production facilities shall be carried out in accordance with Article 8 of this Circular;

b) The Receiving Agency shall issue a notification regarding the GMP compliance status of the production facility and publish it on the Ministry of Health's Electronic Portal and the Receiving Agency's Electronic Information Website as prescribed in Clause 6 of this Article.

5. Handling of periodic assessment results, sudden inspection and assessment results of maintenance of GMP compliance for production facilities of drugs and raw materials for drugs not subject to issuance of Certificates of Compliance for Drug Business Conditions:

a) In cases where the inspection and assessment results conclude that the production facility complies with GMP at levels 1, 2, or 3 as prescribed in point a, b, and point c, Clause 3, Article 7 of this Circular, the inspecting and assessing agency shall handle the matter in accordance with Clauses 1, 2, and 3 of Article 10 of this Circular;

b) In cases where the inspection and assessment results conclude that the production facility complies with GMP at level 4 as prescribed in point d, Clause 3, Article 7 of this Circular, the inspecting and assessing agency shall issue a decision to temporarily halt all production activities or the scope of production activities that do not meet the requirements until the facility implements corrective actions and repairs deficiencies to meet the requirements;

c) In cases where samples of drugs or raw materials for drugs taken during the inspection and assessment are found to violate quality standards, the Receiving Agency shall handle the non-compliant drugs and raw materials in accordance with current regulations on drug quality management. The head of the production facility shall bear legal responsibility for this violation.

6. Within five working days from the date of concluding on the compliance/maintenance of compliance with Good Manufacturing Practices (GMP) for pharmaceutical production facilities and raw material manufacturing facilities not subject to issuance of a Business Registration Certificate for pharmaceuticals, the Receiving Agency shall publish and update the following information on the Ministry of Health's electronic portal and the Receiving Agency’s website:

a) Name and address of the production facility;

b) The name of the person responsible for pharmaceutical specialty, the person in charge of quality assurance, and the Professional Practice Certificate number;

c) The GMP Certificate number;

d) The expiration date of the GMP compliance assessment;

đ) The scope of activities of the production facility.

Chapter V

TECHNICAL PROCEDURE FOR ASSESSING COMPLIANCE AND MAINTENANCE OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICES FOR FOREIGN PHARMACEUTICAL PRODUCTION FACILITIES AND RAW MATERIAL MANUFACTURING FACILITIES WHEN REGISTERING FOR MARKET ENTRY IN VIETNAM

Article 14. Receipt and Organization of Assessment of Compliance and Maintenance of Compliance with Good Manufacturing Practices for Foreign Pharmaceutical Production Facilities and Raw Material Manufacturing Facilities

1. Receipt of Application: The production facility, the drug registration entity, or the raw material manufacturing facility outside Vietnam submits one set of application documents for assessing compliance and maintenance of compliance with GMP according to Clause 2, Article 97 of Decree No. 163/2025/NĐ-CP, along with the review fee as stipulated by the Minister of Finance regarding the review fee for production standards and conditions to the Receiving Agency of the Ministry of Health as follows:

a) The Traditional Medicine Management Department for foreign production facilities that only produce medicinal herbs, traditional drugs, and traditional herbal medicines at the time of submitting the application;

b) The Drug Administration for foreign production facilities that produce raw materials (excluding medicinal herbs), chemical drugs, herbal drugs, vaccines, and biological products at the time of submitting the application;

c) The Drug Administration for foreign production facilities that simultaneously produce one type of drugs or raw materials specified in point a of this clause and one type of drugs or raw materials specified in point b of this clause at the time of submitting the application.

2. The Receiving Agency organizes the receipt, examination, and evaluation of the application documents for assessing compliance and maintenance of compliance with GMP for foreign production facilities and raw material manufacturing facilities. The application documents, procedures, and content of the GMP compliance assessment for foreign production facilities and raw material manufacturing facilities are carried out according to the provisions of Clauses 2, 3, and 4 of Article 93; Clauses 2, 3, and 4 of Article 94; Clauses 2, 3, and 4 of Article 95; Clauses 1, 2, 3, and 4 of Article 96; and Clauses 2, 3, 4, 5, 6, and 7 of Article 97 of Decree No. 163/2025/NĐ-CP.

3. The GMP standard principles serve as the basis for evaluating GMP compliance at foreign production facilities according to Clause 1 of Article 97 of Decree No. 163/2025/NĐ-CP.

4. Based on their assigned functions and tasks, the Receiving Agency establishes a specialized expert team for review, formulates regulations, and organizes the operation of the expert team to evaluate the application documents for assessing compliance and maintenance of compliance with GMP and publishes the status of GMP compliance and maintenance of compliance for foreign production facilities and raw material manufacturing facilities. The organization costs for the review process are implemented according to the law.

5. Principles of Operation for Experts:

a) Review opinions must be based on legal grounds, scientific foundations, and must be reflected in the review minutes;

b) The reviewing expert is responsible to the head of the Receiving Agency for the contents of the review, recommendations related to the review work.

Article 15. The technical procedures for evaluating compliance with and maintaining compliance with Good Manufacturing Practices (GMP) for pharmaceutical production facilities and raw material manufacturing facilities as stipulated in Articles 93, 94, 95, and 96 of Decree No. 163/2025/NĐ-CP

1. Within two working days from the date of receipt, the Receiving Agency shall review the formal suitability of the evaluation request proposed and transfer the evaluation request file along with the corresponding inspection report form to the evaluator.

2. In eight days for cases where the evaluation facility submits additional documents as provided for in point e, Clause 2, Article 93 or as provided for in Clause 2, Article 94 or Clauses 1 and 2, Article 96 of Decree No. 163/2025/NĐ-CP, and thirty days for cases where the evaluation request file of the facility only includes documents as provided for in points a, b, c, d, đ, Clause 2, Article 93 of Decree No. 163/2025/NĐ-CP dated June 29, 2025, the Evaluation Team shall conduct the evaluation of the evaluation request file according to the content specified in Clause 4 of Articles 93, 94, 95, and 96 of Decree No. 163/2025/NĐ-CP, fill in the evaluation information for each item in the evaluation report, and issue a conclusion on the GMP compliance status of the facility.

3. Within four working days from the date of receiving the conclusion of the Evaluation Team, the Receiving Agency shall review the evaluators' conclusions, approve the evaluation results. In case the evaluators do not reach a consensus on the conclusion, the Receiving Agency shall return the file to the evaluators for re-examination and unification for joint evaluation of the file. In case the evaluators still do not reach a consensus on the conclusion, the Receiving Agency shall review the entire file, the opinions of the evaluators, and issue a final conclusion.

4. Within one working day from the date of the file conclusion, the Receiving Agency shall issue a notification regarding the GMP compliance status of the production facility. In case the file does not meet or fails to meet GMP requirements, the response must clearly state the reasons.

5. Within three working days from the date of obtaining the evaluation compliance result, the Receiving Agency shall publish information about foreign pharmaceutical production facilities and raw material manufacturing facilities that have been evaluated for compliance and maintenance of GMP on the Ministry of Health's electronic portal and the Receiving Agency's website.

6. The Receiving Agency shall process supplementary files of the facility according to the procedures stipulated in Clauses 1, 2, 3, 4, and 5 above within the following timeframes:

a) Within fifteen days from the date of receiving the supplementary file of the facility as required under Clause 4 of this Article for cases where the evaluation facility submits the file according to the provisions or as provided for in Clause 2, Article 94 or Clauses 1 and 2, Article 96 of Decree No. 163/2025/NĐ-CP;

b) Within thirty days from the date of receiving the supplementary file of the facility as required under Clause 4 of this Article for cases where the evaluation facility submits the file according to Clause 2, Article 93 of Decree No. 163/2025/NĐ-CP.

Article 16. The technical procedures for evaluating compliance with Good Manufacturing Practices (GMP) for pharmaceutical production facilities and raw material manufacturing facilities through on-site evaluation at the production facility as stipulated in Article 95 of Decree No. 163/2025/NĐ-CP

1. Within fifteen days from the date of receiving all necessary files for cases as provided for in points b, d, and đ, Clause 1, Article 95 of Decree No. 163/2025/NĐ-CP or from the date of notifying the pre-evaluation result of the drug registration file or the evaluation request file for compliance with Good Manufacturing Practices for cases as provided for in points a and c, Clause 1, Article 95 of Decree No. 163/2025/NĐ-CP, the Receiving Agency shall review the formal suitability of the proposed evaluation, check the completeness of the evaluation request file, develop a plan for inspection, and issue a decision to establish an On-Site Evaluation Team according to Articles 18 and 19 of this Circular and transfer the evaluation request file to the members of the On-Site Evaluation Team. In case the file is incomplete, the Receiving Agency shall issue a document requesting supplementation.

2. Within thirty days from the date of the Decision establishing the Evaluation Team, the Team Leader shall assign team members to prepare the procedures for traveling abroad, develop the Evaluation Program, and send it to the evaluated production facility. The Evaluation Program must ensure compliance with the evaluation content specified in Clause 4, Article 95 of Decree No. 163/2025/NĐ-CP, be suitable for the type of drug formulation registered or the scope of production of the production facility. The Evaluation Program may be adjusted during the evaluation if additional points requiring detailed evaluation or expanded evaluation subjects and scopes are identified.

3. Within fifteen days from the date of sending the Evaluation Program to the facility, the Evaluation Team shall conduct on-site inspections at the facility. The on-site inspection procedures shall be carried out according to points a, b, c, d, đ, Clause 2, Article 7 of this Circular. The Evaluation Program may be adjusted based on the issues discovered during the evaluation.

4. Within twenty days from the end of the evaluation at the facility, the Evaluation Team shall prepare a GMP Practice Evaluation Report according to Form No. 04 stipulated in Appendix X issued together with this Circular. The evaluation report shall be reviewed, completed, and signed by the team members and submitted to the Receiving Agency. The classification of issues and the degree of GMP compliance of the production facility shall be conducted according to Clause 3, Article 7 and Appendix IX issued together with this Circular.

5. Within ten days from the date of receiving the Evaluation Team's evaluation report, the Receiving Agency shall review the Evaluation Minutes, evaluation content, and evaluation conclusion on the level of compliance at the GMP Evaluation Report, discuss the Evaluation Team's evaluation results if necessary, and issue a notification of the GMP compliance evaluation conclusion of the production facility. In case the production facility does not meet or fails to meet GMP requirements, the response must clearly state the reasons.

6. Within three working days from the date of concluding that the facility meets GMP standards, the Agency receiving the announcement of information on foreign production facilities evaluated to meet GMP standards shall publish such information on the Ministry of Health's electronic portal and the Agency's website.

7. The procedure for processing supplementary files as required under Clause 5 of this Article shall be carried out as follows:

a) Within one working day from the date of receipt of supplementary files, the Agency receiving shall transfer the supplementary files to the Inspection Team.

b) Within twenty-nine days from the date of receipt of supplementary files from the facility, the Inspection Team shall conduct a review and evaluation of the supplementary files submitted by the production facility; prepare a report on the evaluation of supplementary files, provide an opinion on the degree of compliance with GMP standards of the production facility, and send it to the Agency receiving.

c) Within ten days from the date of receipt of the report on the evaluation of supplementary files from the Evaluation Team, the Agency receiving shall conduct a review of the evaluation report, conclude on the degree of evaluation of compliance with GMP standards provided by the Evaluation Team, exchange opinions and clarify (if necessary); issue a notification document on the conclusion of the evaluation of compliance with GMP standards sent to the production facility or the drug registration entity named in the application for evaluation of compliance with GMP standards. In cases where the production facility has not met or does not meet GMP standards, the response document to the facility must clearly state the reasons.

Article 17. Information Announced Regarding Compliance with Good Manufacturing Practices for Drug Production Facilities and Active Pharmaceutical Ingredient Production Facilities Located Abroad

1. Within three working days from the date of obtaining the results of the evaluation of the production facility meeting GMP standards, the Agency receiving shall announce and update the results of the evaluation of compliance with GMP standards of drug production facilities and active pharmaceutical ingredient production facilities located abroad on the Ministry of Health's electronic portal and the Agency's website. The announced information includes:

a) Name and address of the production facility (address of the factory/production line being evaluated);

b) Number of the GMP Certificate/Production License/Good Manufacturing Practice Inspection Report or other documents as stipulated in Clause 5 of Article 97 of Decree No. 163/2025/NĐ-CP issued by the local regulatory authority, validity period; GMP standard principles and issuing authority. In cases where the production facility belongs to a member country of PIC/S, the PIC/S-GMP standard principles along with the GMP standard principles recorded on the GMP Certificate/Production License/Good Manufacturing Practice Inspection Report;

c) Number of the EU-GMP Certificate or equivalent EU-GMP Certificate/Production License/Good Manufacturing Practice Inspection Report, validity period, and issuing authority for production facilities that have been evaluated as compliant with EU-GMP or equivalent EU-GMP standards by one of the stringent regulatory authorities (SRA) or drug regulatory authorities recognized by the Ministry of Health based on WHO classification;

d) Scope of production activities already evaluated by the production facility corresponding to each GMP Certificate.

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

a) Validity period recorded on the GMP Certificate, Production License, or Good Manufacturing Practice Inspection Report;

b) Regulations of the drug regulatory authority or competent authority of the issuing country, evaluating compliance with GMP standards;

c) Policy on extending the validity period of compliance with GMP standards of the issuing and evaluating authority.

3. The scope of certification of compliance with GMP standards is defined based on the following grounds:

a) The scope of GMP certification requested for evaluation by the registering entity, drug production facility, or active pharmaceutical ingredient production facility;

b) The scope of certification recorded on the GMP Certificate/Production License or Good Manufacturing Practice Inspection Report;

c) Physical infrastructure and production equipment conditions of the production facility.

Chapter VI

MEMBERS OF THE ON-SITE EVALUATION TEAM, EXPERTS EVALUATING THE COMPLIANCE WITH GOOD MANUFACTURING PRACTICES FOR DRUGS AND ACTIVE PHARMACEUTICAL INGREDIENTS

Article 18. Standards for members of the Inspection Team to meet and maintain Good Manufacturing Practice (GMP) through on-site inspections at production facilities, experts reviewing applications for GMP compliance assessment

1. Members of the Inspection Team to meet and maintain GMP through on-site inspections at production facilities, experts reviewing applications for GMP compliance assessment must meet the following standards:

a) Hold a bachelor's degree or higher and have been trained in subjects related to medicine, pharmacy, biology, pharmaceutical quality management, and drug administration;

b) Have been trained and instructed on GMP, inspection, and assessment of GMP, and thoroughly understand the principles and standards of GMP. Specifically, members participating in the Inspection Team for traditional medicine and herbal product manufacturing facilities must be trained and instructed on GMP for traditional medicine and herbal products;

c) Be honest, impartial, and strictly comply with all regulations and laws during the assessment process, without having conflicts of interest with the assessed production facility as stipulated in Clause 4 of this Article;

d) The Head of the Inspection Team must have at least three years of experience in pharmaceutical administration work.

2. Composition of the Inspection Team to meet and maintain GMP through on-site inspections at production facilities includes:

a) The Head of the Team and one or two members from the Receiving Agency. For production facilities specified in point c, Clause 1, Article 6 of this Circular, one or two additional members from the Traditional Medicine and Pharmaceutical Administration Department shall be included;

b) One member representing the Central Institute for Drug Testing or the Ho Chi Minh City Institute for Drug Testing or the National Institute for Vaccine and Biomedical Product Quality Control (for vaccine and biopharmaceutical production facilities);

c) One member representing the Health Department of the province or centrally-administered city where the domestic drug and raw material production plant is located;

d) Relevant agency members when necessary.

3. Composition of experts reviewing applications for GMP compliance assessment for drug and raw material production facilities abroad:

a) Two experts for applications for GMP compliance assessment through mutual recognition of inspection results of the national pharmaceutical regulatory authority for requirements and applications for maintaining GMP compliance assessment of such facilities;

b) Three experts for applications for GMP compliance assessment through review of relevant production condition documentation and applications for maintaining GMP compliance assessment of such facilities.

4. Conflict of Interest Assessment Principle: Members of the on-site Inspection Team and experts reviewing applications are considered to have a conflict of interest with the assessed production facility if they fall under any of the following circumstances:

a) Have worked or participated in advisory activities for the assessed production facility within the last five years;

b) Currently have financial interests with the assessed production facility;

c) Have a spouse, child, parent, full sibling, parent-in-law, or parent of spouse working for the assessed production facility.

Article 19. Responsibilities and authorities of members of the on-site inspection team and experts reviewing documentation

1. Responsibilities of the Inspection Team:

a) Assess all activities of the production facility according to the principles and standards of Good Manufacturing Practice (GMP) as stipulated in Article 3 of this Circular, the updated versions of GMP principles and standards, and related regulatory documents and professional regulations; record specific contents of the assessment, issues identified, prepare inspection reports for documentation reviews and inspection reports/reports of on-site inspections; opinions on assessments and inspections must be based on legal grounds and scientific foundations and must be reflected in the inspection report for documentation reviews and the report of on-site inspections;

b) Report the results of the assessment or explain the GMP assessment report when the production facility has differing opinions with the content of the GMP Assessment Report;

c) Be responsible before the Receiving Authority for all assessment contents. Maintain confidentiality of all information related to the assessment and all information related to production, quality control, storage, and distribution of drugs (production processes, testing, sanitation, technological secrets...), except where the production facility agrees or upon request of competent state agencies for inspection and investigation purposes;

2. Authorities of the Inspection Team:

a) Inspect all areas and workshops within the production facility, and have the authority to request inspections of other relevant areas related to production, storage, and testing of drugs and drug ingredients. For traditional herbal medicine production, additional inspection of processing and production procedures of traditional herbal medicines at the proposed production site shall be conducted;

b) Request provision of documents and materials related to quality management, production, testing, and storage of drugs and drug ingredients;

c) Collect documents and materials, evidence (photocopies of documents, photographs, videos...) regarding issues identified during the assessment;

d) Take samples of drugs, semi-finished products, medicinal herbs, and drug ingredients for quality testing as prescribed by law;

đ) Prepare records and require the production facility to temporarily suspend one, some, or all production activities related to violations. If during the assessment, the Inspection Team discovers serious violations affecting the quality of one or more drug products or drug ingredients, they must report to the competent authority for handling in accordance with the law;

3. Responsibilities of experts reviewing documentation:

a) Evaluate and review the compliance with GMP of foreign drug manufacturing facilities through documentation review to publish a list of foreign drug manufacturing facilities that comply with GMP when registering for circulation in Vietnam; prepare inspection reports for documentation reviews and record comments corresponding to each item on the inspection report and provide opinions on reviewed documents, inspection and evaluation opinions must be based on legal grounds and scientific foundations and must ensure completeness, accuracy, and compliance with regulations on good manufacturing practices for drugs and drug ingredients, guidance letters, technical guidelines, and related professional documents;

b) Be responsible before the Receiving Authority for all assessment contents. Maintain confidentiality of all information related to the assessment and all information related to production, quality control, storage, and distribution of drugs (production processes, testing, sanitation, technological secrets...), except where the production facility agrees or upon request of competent state agencies for inspection and investigation purposes;

4. Authorities of experts reviewing documentation:

a) Receive full access to regulatory documents, guidance letters related to good manufacturing practices for drugs and drug ingredients to serve the assessment process;

b) Request supplementary documents as required by law to serve the assessment process;

c) Propose on-site inspection recommendations for foreign drug manufacturing facilities applying for GMP compliance assessment in accordance with point c, Clause 1, Article 95 of Decree No. 163/2025/NĐ-CP;

Chapter VII

IMPLEMENTING PROVISIONS

Article 20. Effective Date

Article 32. Responsibilities of Agencies

2. The following documents and provisions cease to be effective from the date this Circular takes effect:

a) Circular No. 35/2018/TT-BYT dated November 22, 2018, issued by the Minister of Health on Good Manufacturing Practices for Drugs and Drug Ingredients;

b) Circular No. 12/2022/TT-BYT dated November 21, 2022, issued by the Ministry of Health amending and supplementing certain articles of Circular No. 35/2018/TT-BYT dated November 22, 2018, issued by the Minister of Health on Good Manufacturing Practices for Drugs and Drug Ingredients;

c) Clause 6, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020, amending, supplementing, and abolishing certain legal regulatory documents issued by the Minister of Health, jointly issued;

Article 21. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 22. Transitional provisions

1. For applications for a Business Registration Certificate for pharmaceutical operations or periodic GMP compliance assessment applications submitted to the Receiving Authority before the effective date of this Circular, the Receiving Authority will continue to assess the production facility according to Circular No. 35/2018/TT-BYT on Good Manufacturing Practices for Drugs and Drug Ingredients or according to this Circular if the production facility requests;

2. For production facilities currently producing prescription chemical drugs that change their scope of operation to only produce non-prescription chemical drugs must:

a) Follow the procedure to adjust the Business Registration Certificate for pharmaceutical operations as stipulated in Clause 1, Article 20 of Decree No. 163/2025/NĐ-CP;

b) Cease production of prescription chemical drugs from the date the adjusted Business Registration Certificate is issued in accordance with point a of this clause; simultaneously carry out legal procedures to withdraw the registration certificates for the circulation of prescription drugs;

Article 23. Responsibility for Implementation

1. The Drug Administration Department shall be responsible for:

a) Lead and coordinate with relevant units to organize the implementation, dissemination, and popularization of this Circular in accordance with assigned functions and tasks;

b) Implement this Circular for the Department of Health, the Health Industry, and drug manufacturing facilities and raw material production facilities within their assigned functions and tasks;

c) Compile and publish on the Electronic Information Portal of the Drug Administration Department the list of national manufacturing facilities that have been issued a Business Condition Compliance Certificate and/or a GMP Certificate; update the status of the Business Condition Compliance Certificate and/or the GMP Certificate, the GMP compliance status, and other information as prescribed in Clause 6, Article 8 of this Circular within the scope of their assigned functions and tasks;

d) Publish updated GMP documentation on the Ministry of Health's Electronic Information Portal and the Drug Administration Department's Electronic Information Portal;

e) Serve as the focal point or coordinate with relevant agencies to conduct inspections and audits of GMP compliance adherence and handle violations within their authority;

2. The Traditional Medicine Management Department shall be responsible for:

a) Lead and coordinate with relevant units to organize the implementation, dissemination, and popularization of this Circular in accordance with assigned functions and tasks;

b) Compile and publish on the Electronic Information Portal of the Traditional Medicine Management Department the list of national manufacturing facilities that have been issued a Business Condition Compliance Certificate or a GMP Certificate; update the status of the Business Condition Compliance Certificate or the GMP Certificate, the GMP compliance status, and other information as prescribed in Clause 6, Article 8 of this Circular within the scope of their assigned functions and tasks;

c) Coordinate with the Drug Administration Department in evaluating, issuing certificates, and announcing Good Manufacturing Practice compliance for manufacturing facilities specified in Point c, Clause 1, Article 6 of this Circular upon issuance of a Decision establishing the Inspection Team;

d) Serve as the focal point or coordinate with relevant agencies to conduct inspections and audits of GMP compliance adherence and handle violations within their authority;

3. Provincial Health Departments are responsible for:

a) Coordinate with related units to organize the dissemination and guidance on implementing this Circular for units within their jurisdiction;

b) Participate in inspection teams, audits, and evaluations of GMP compliance; supervise and handle violations within their authority regarding drug manufacturing facilities and raw material production facilities within their jurisdiction;

4. The Central Institute of Pharmaceutical Testing, the Ho Chi Minh City Institute of Pharmaceutical Testing, and the National Institute of Vaccine and Biological Products shall participate in the GMP evaluation team upon issuance of a Decision establishing the team;

5. Drug manufacturing facilities and raw material production facilities shall be responsible for:

a) Organizing the implementation of this Circular;

b) Ensuring continuous compliance with GMP principles and standards throughout the operation of the manufacturing facility;

c) Conducting production activities within the scope evaluated and permitted based on compliance with legal regulations;

d) Finished drug and semi-finished drug manufacturing facilities shall base their self-assessment of compliance with the GMP principles and standards stipulated in Point đ, Clause 1, Article 3 and Point b, Clause 3, Article 3 of this Circular for excipients used at the facility according to the purpose and usage range of excipients at the facility;

đ) Drug manufacturing facilities producing health food and semi-finished health food as specified in Article 4 must fully comply with all relevant legal regulations concerning health food management;

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals should report to the Ministry of Health (Drug Administration Department, Traditional Medicine Management Department) for consideration and resolution.