Circular 45/2026/TT-BYT amend Circular 28/2025/TT-BYT on Good Manufacturing Practices for medicinal products and medicinal materials

CIRCULAR

Amending and supplementing a number of articles of Circular No. 28/2025/TT-BYT dated July 01, 2025 of the Minister of Health prescribing Good Manufacturing Practices for medicinal products and medicinal materials

Pursuant to the Law No. 105/2016/QH13 on Pharmacy, which is amended and supplemented by Law No. 44/2024/QH15;

Pursuant to the Government’s Decree No. 163/2025/ND-CP detailing a number of articles and measures for organizing and guiding the implementation of the Law on Pharmacy;

Pursuant to the Government's Decree No. 313/2026/ND-CP defining the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam and the Director of the Traditional Medicine Administration of Vietnam;

The Minister of Health hereby promulgates the Circular amending and supplementing a number of articles of Circular No. 28/2025/TT-BYT dated July 01, 2025 of the Minister of Health prescribing Good Manufacturing Practices for medicinal products and medicinal materials.

Article 1. Adding Clause 14, Clause 15, and Clause 16 after Clause 13, Article 2

“14. Manufacture of radiopharmaceuticals at healthcare establishments means the manufacture of radionuclides using a cyclotron, and the synthesis and formulation of radiopharmaceuticals from radionuclides produced by a cyclotron.

15. Preparation of radiopharmaceuticals at healthcare establishments means one or more of the following activities: separation and elution of radionuclides from a radionuclide generator; radiolabeling of radionuclides with labelling agents (precursors); use of radionuclides for reconstitution and preparation with carriers for radiolabeling; and withdrawal, dispensing, and dilution of radiopharmaceuticals, in accordance with Circular No. 30/2021/TT-BYT of the Minister of Health on the preparation of medicinal products for patient treatment at healthcare establishments.

16. Processor of herbal medicinal materials means an establishment that applies the methods for processing herbal medicinal materials and traditional herbal ingredients prescribed in Circular No. 14/2024/TT-BYT of the Minister of Health guiding the methods for processing herbal medicinal materials and traditional medicinal products.”

Article 2. Amending and supplementing a number of clauses of Article 3

1. To add Point dd and Point e after Point d, Clause 1 of Article 3 as follows:

dd) Good Manufacturing Practices principles and standards recommended by the World Health Organization (WHO-GMP) applicable to the manufacture of investigational medicinal products and medicinal products used in clinical trials, as prescribed in Appendix XII to this Circular and the updated documents prescribed in Clause 4 of this Article;

e) Good Manufacturing Practices principles and standards for the manufacture of radiopharmaceuticals at healthcare establishments, prescribed in Appendix XIII to this Circular.”

2. To amend and supplement Point b, Clause 4, Article 3 as follows:

“b) In case the World Health Organization, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or the European Union has updated documents as prescribed at Points c, d and dd, 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 of the updated documents, 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 3. Amending and supplementing a number of clauses of Article 4

1. To amend and supplement Clause 1, Article 4 as follows:

“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 Appendix I, Appendix III, or Appendix IV to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular;

Manufacturers of investigational medicinal products and medicinal products for use in clinical trials shall implement GMP as prescribed in Appendix XII to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular;

Healthcare establishments manufacturing radiopharmaceuticals shall implement the GMP principles and standards prescribed in Appendix XIII to this Circular.”

2. To amend and supplement Clause 3, Clause 4, Clause 5 and Clause 6, Article 4 as follows:

“3. Manufacturers of herbal medicinal products shall implement the GMP principles and standards prescribed in Appendix V to this Circular;

Manufacturers of materials from herbal medicinal materials in modern dosage forms shall implement the GMP principles and standards prescribed in Appendix V or Part II, Appendix VI to this Circular;

Manufacturers of materials from herbal medicinal materials in traditional dosage forms shall implement the GMP principles and standards prescribed in Part I, Appendix VI to this Circular, unless otherwise prescribed in Clause 6 of this Article.

4. Manufacturers of exclusively traditional medicinal products in traditional dosage forms (extracts, pellets, powders, medicated wines, and tinctures) shall implement the GMP principles and standards prescribed in Part I, Appendix VI to this Circular.

5. Manufacturers of traditional medicinal products in modern dosage forms (capsules, tablets, granules) and other dosage forms shall implement GMP as prescribed in Part II, Appendix VI to this Circular.

6. Processors of herbal medicinal materials shall implement GMP as prescribed in Appendix VII to this Circular.”

3. To amend and supplement Clause 8 and Clause 9 of Article 4 as follows:

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

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

Processors of herbal medicinal materials may implement the GMP principles and standards prescribed in Appendix I, Appendix III, Appendix IV, Appendix V, or Appendix VI to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.”

4. To amend and supplement Point a, Clause 10, Article 4 as follows:

a) Medicinal products and medicinal materials containing beta-lactam antibiotics (Penicillins, Cephalosporins, Penems, and the like), cytotoxic drugs, medicinal products containing sex hormones of the contraceptive group, vaccines, biologicals containing probiotics, radiopharmaceuticals and radioactive medicinal materials, 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 establishment implementing the corresponding GMP principles and standards as prescribed in this Article, must be manufactured on separate production lines (separate premises, separate production equipment, separate auxiliary system) and have measures to prevent dispersion and contamination of the environment and other medicinal products manufactured in the same area;”

5. To amend and supplement Clause 12, Article 4 as follows:

“12. Manufacturers of exclusively non-prescription chemical medicinal products may manufacture herbal medicinal products, traditional medicinal products, and health supplements with dosage forms corresponding to the certified dosage forms, excluding health supplements containing probiotics. These manufacturers must implement the GMP principles and standards prescribed in Appendix I, Appendix III, or Appendix IV to this Circular and the updated documents as prescribed in Clause 4, Article 3 of this Circular.”

6. To amend and supplement Clause 17, Article 4 as follows:

“17. Manufacturers operating separate production lines exclusively for biological medicinal products or medicinal materials containing probiotics are permitted to manufacture materials and health supplements in dosage forms corresponding to their certified dosage forms, provided that they contain the same probiotics or probiotics combined with vitamins.”

Article 4. Amending and supplementing Point c, Point d, and Point dd, Clause 2, Article 7

“c) Step 3. The Inspection Team conducts an on-site inspection of the GMP implementation at each production line of the manufacturer regarding each specific matter. In case the manufacturer performs one or some of the stages of the manufacturing process, the inspection shall only cover the requirements corresponding to the one or some manufacturing stages that the manufacturer performs. The inspection agenda may be adjusted according to the actual implementation situation or deficiencies of the manufacturer discovered during the inspection;

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

dd) Step 5. Make and sign the written record of inspection:

After reaching an agreement with the establishment, the Inspection Team makes a written record of inspection using Form No. 03 in Appendix X to this Circular. The written record of inspection must state the composition of the Inspection Team, the manufacturer’s representatives, the location, the time, the scope of the inspection, the form of the inspection, the deficiencies identified during the inspection, the classification of the deficiencies by level of severity, and the manufacturer’s level of compliance. It must also clearly state any matters on which the Inspection Team and the manufacturer have not reached agreement (if any). The head of the manufacturer and the members of the Inspection Team shall sign the written record of inspection. The written record shall be made in 02 copies, of which 01 is kept by the manufacturer and 01 is kept by the Receiving Authority.”

Article 5. Amending and supplementing a number of clauses of Article 8

1. To amend and supplement Point b and Point c, Clause 2, Article 8 as follows:

b) The manufacturer must submit a written report on the remediation, accompanied by supporting evidence (documents, photos, videos, certificates, or other supporting documents) for the deficiencies that have been corrected, and a corrective action plan with a committed completion deadline for the deficiencies that have not yet been corrected;

c) Within 20 days from the date of receipt of the manufacturer’s written report on the correction and remediation of deficiencies, the Receiving Authority shall evaluate the manufacturer’s corrective results according to the documents prescribed in Clause 1, Article 7 of this Circular; conduct an on-site inspection of the corrections of major deficiencies prescribed in Appendix IX to this Circular, or of the corrective actions for other deficiencies where the remediation dossier does not specify them clearly, where their actual implementation needs to be verified, or where the documents contain discrepancies or insufficient evidence for consideration; prepare a report on the evaluation of the manufacturer’s remediation of deficiencies, and conclude on the manufacturer’s GMP compliance:

- The Receiving Authority shall propose the issuance of a Certificate of Eligibility for Pharmaceutical Business to the Minister of Health and shall itself issue a GMP Certificate (in case the manufacturer so requests) using Form No. 05 in Appendix X to this Circular if the manufacturer's corrective actions are deemed satisfactory and the manufacturer is concluded to be GMP-compliant;

- The Receiving Authority shall send a written notice to the manufacturer stating the reasons for the conclusion that the manufacturer is not GMP-compliant;”

2. To amend and supplement Clause 4, Article 8 as follows:

“4. In case the GMP inspection report concludes that the manufacturer or production line 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 inspection report, the Receiving Authority shall issue a written notice of non-compliance with GMP by the manufacturer or its production line using Form No. 16 in Appendix I to Decree No. 163/2025/ND-CP, accompanied by the GMP inspection report sent to the manufacturer, and shall not issue a Certificate of Eligibility for Pharmaceutical Business to the manufacturer or for the scope of non-compliance by the manufacturer.”

Article 6. Amending and supplementing Clause 2, Article 9

“2. In November of each year, the Receiving Authority shall review and issue plans for the routine inspections and surveillance inspections of GMP compliance for manufacturers in the following year. The plans for routine inspections of GMP compliance shall be publicly disclosed on the website of the Receiving Authority. For manufacturers as prescribed in Clause 3, Article 5 of this Circular, the Drug Administration of Vietnam shall publicly disclose and implement the plans for routine inspections of GMP compliance as well as inspect GDP compliance upon request by the manufacturers.”

Article 7. Amending and supplementing a number of clauses of Article 10

1. To amend and supplement Point b, Point c, and Point d, Clause 2, Article 10 as follows:

b) Within 45 days from the date on which the Receiving Authority sends the GMP inspection report, the manufacturer must submit a report on the remediation, accompanied by supporting evidence (documents, photos, videos, certificates, or other supporting documents) for the deficiencies that have been corrected, and a corrective action plan with a committed completion deadline for the deficiencies that have not yet been corrected;

c) Within 20 days from the date of receipt of the written report on remediation, the Receiving Authority shall evaluate the manufacturer’s corrective results; conduct an on-site inspection of the corrections of major deficiencies prescribed in Appendix IX, or of the corrective actions for other deficiencies where the remediation dossier does not specify them clearly, where their actual implementation needs to be verified, or where the documents contain discrepancies or insufficient evidence for consideration. Based on its evaluation, the Receiving Authority shall conclude on the manufacturer’s GMP compliance:

- If the manufacturer's corrective actions are satisfactory: The Receiving Authority shall update the information on the manufacturer's GMP compliance on the portal of the Ministry of Health and the website of the Receiving Authority in accordance with Clause 6, Article 8 of this Circular and shall issue a GMP Certificate using Form No. 05 in Appendix X to this Circular if the manufacturer requests it.

- If the manufacturer's corrective actions are unsatisfactory: The Receiving Authority shall issue a written notice of the details to be further corrected and remedied and request submission of a supplementary report. The extension period for further correction, remediation, and reporting is 45 days from the date of the written request;

d) If the manufacturer fails to submit a corrective action report within 135 days from the date of finalization of the GMP inspection report, or if the results remain unsatisfactory following the implementation of corrective actions as prescribed at Point c of this Clause, the Receiving Authority shall issue a written notice of GMP non-compliance by the manufacturer or production line and, depending on the nature and severity of the violation, apply one or more of the measures prescribed at Point a and Point b, Clause 4 of this Article.”

2. To amend and supplement Clause 4, Article 10 as follows:

“4. In case the GMP inspection report concludes that the manufacturer or production line 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 inspection, 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 by the manufacturer or its production line, accompanied by the GMP inspection report. Depending on the nature and severity of the violation, the Receiving Authority shall apply one or more of the following measures:

a) Issue a document to suspend the operations of the manufacturer or its non-compliant production line; sanction by itself, or transfer the case to a competent authority for sanctioning of, any administrative violation in accordance with the law on handling of administrative violations;

b) Propose issuance of a decision to revoke the issued Certificate of Eligibility for Pharmaceutical Business to the Minister of Health in accordance with 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 case 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; sanction by itself, or transfer the case to a competent authority for sanctioning of, any administrative violation in accordance with the law on handling of administrative violations.

- Propose issuance of a decision to revoke the issued Certificate of Eligibility for Pharmaceutical Business to the Minister of Health in order 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 within 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.”

Article 8. Amending and supplementing Article 11

“Article 11. Control of changes

1. A vaccine manufacturer must submit a written notification accompanied by a risk assessment of the impact of the planned changes on product quality and safety before implementing changes in one of the following cases:

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

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

c) Change of major, critical production equipment that affects the manufacturing process or the quality of the medicinal products or medicinal materials;

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

dd) 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. The manufacturer shall apply for a Certificate of Eligibility for Pharmaceutical Business after any change in one of the following cases:

a) One of the changes prescribed at Point b, Clause 1, Article 36 of the Law on Pharmacy with respect to the manufacturing plant, storage warehouse, or quality control laboratory;

b) The manufacturer switches its scope of manufacturing from herbal and traditional medicinal products to non-prescription chemical medicinal products.

3. The manufacturer shall request the amendment of the Certificate of Eligibility for Pharmaceutical Business after any change in one of the following cases:

a) The manufacturer switches its scope of manufacturing from chemical medicinal products to non-prescription chemical medicinal products;

b) The manufacturer of non-prescription chemical medicinal products switches to manufacturing chemical medicinal products.

4. The manufacturer shall submit a change report using Form No. 06 in Appendix X to this Circular and the corresponding technical documents so that the Receiving Authority may conduct an on-site inspection of any change in one of the following cases:

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

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

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

d) The manufacturer of sterile medicinal products and medicinal materials repairs or changes the structure or layout of a part of a production line that alters the manufacturing environment or manufacturing process;

dd) The manufacturer of sterile medicinal products and medicinal materials changes major, critical production equipment that affects the manufacturing process or the quality of the medicinal products or medicinal materials;

e) The manufacturer of sterile medicinal products and medicinal materials changes the auxiliary system or changes the design principle or operation of the utility system that affects the manufacturing environment;

g) Change of the location of the storage warehouse (for materials, primary packaging, finished products) or quality control laboratory (microbiological testing area) at the same business address;

h) Addition of a storage warehouse (for materials, primary packaging, finished products) or quality control laboratory (microbiological testing area) at a new location at the same business address.

5. The manufacturer shall submit a change report using Form No. 06 in Appendix X to this Circular and the corresponding technical documents to the Receiving Authority for any change in one of the following cases:

a) Repair or change in the structure or layout of a part of a production line that alters the manufacturing environment or manufacturing process, unless otherwise prescribed at Point d, Clause 4 of this Article;

b) Change of major, critical production equipment that affects the manufacturing process or the quality of the medicinal products or medicinal materials, unless otherwise prescribed at Point dd, Clause 4 of this Article;

c) Change in the auxiliary system or change in the design principle or operation of the utility system that affects the manufacturing environment, unless otherwise prescribed at Point e, Clause 4 of this Article;

d) Expansion of the storage warehouse or quality control laboratory (microbiological testing area) based on the existing structure of the warehouse or microbiological testing area, which alters the storage conditions or testing environment;

dd) Repair or major change in the structure or layout of the storage warehouse or quality control laboratory (microbiological testing area) that alters the storage conditions or testing environment;

e) Change in the auxiliary system or change in the design principle or operation of the utility system that affects the storage requirements and conditions at the storage warehouse or the testing environment.

6. A manufacturer that undergoes a change in one of the cases prescribed in Clause 2 of this Article must submit a dossier of application for a Certificate of Eligibility for Pharmaceutical Business in accordance with Clause 2 and Clause 4, Article 38 of the Law on Pharmacy.

The procedures for GMP compliance inspection, classification of inspection results, and handling of GMP compliance inspection results shall comply with Article 6, Article 7, and Article 8 of this Circular.

The manufacturer may conduct manufacturing operations within the requested scope only after being issued the Certificate of Eligibility for Pharmaceutical Business.

7. A manufacturer that undergoes a change in one of the cases prescribed in Clause 3 of this Article shall carry out the procedure to amend its Certificate of Eligibility for Pharmaceutical Business in accordance with Clause 1, Article 20 of Decree No. 163/2025/ND-CP.

The Receiving Authority shall carry out the procedure to amend the Certificate of Eligibility for Pharmaceutical Business in accordance with Clause 1, Article 20 of Decree No. 163/2025/ND-CP; the manufacturer may commence the manufacture of medicinal products and medicinal materials within the converted scope only after its Certificate of Eligibility for Pharmaceutical Business has been amended.

8. A manufacturer undergoing one of the changes prescribed in Clause 4 of this Article shall submit a change report together with the corresponding technical documents to the Receiving Authority. The inspection and handling of inspection results shall be carried out as follows:

a) The Receiving Authority shall conduct an on-site inspection 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 procedures for inspection, classification of inspection results, and handling of the GMP compliance inspection results for manufacturers undergoing changes as prescribed at Point a or Point g, Clause 4 of this Article shall comply with Article 6, Article 7 and Article 10 of this Circular;

c) The procedures for inspection, classification of inspection results, and handling of the GMP compliance inspection results for manufacturers undergoing changes as prescribed at Points b, c, d, dd, e and h, Clause 4 of this Article shall comply with Article 6, Article 7, and Article 8 of this Circular.

9. A manufacturer undergoing one of the changes prescribed in Clause 5 of this Article shall submit a change report together with the 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 a special inspection and handle the inspection results in accordance with Article 12 of this Circular in case the change report does not provide sufficient evidence of GMP compliance by the manufacturer.

10. In case a manufacturer is 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 the World Health Organization’s classification and requests public disclosure on the website of the Receiving Authority:

a) The manufacturer shall submit a written request for public disclosure accompanied by the GMP Certificate or a document concluding that the manufacturer complies with EU-GMP or EU-GMP equivalent and the GMP inspection report issued by the SRA or the drug regulatory authority recognized by the Ministry of Health based on the World Health Organization’s classification;

b) Within 15 days from the date of receiving the request dossier, the Receiving Authority shall review the request dossier and information stated on the Certificate of Eligibility for Pharmaceutical Business (business form: manufacture of medicinal products) of the manufacturer and publicly disclose it on the portal of the Ministry of Health and the website of the Receiving Authority. The information to be publicly disclosed includes:

- Name and address of the manufacturer (Address of the inspected plant/production line).

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

c) A manufacturer of medicinal products or medicinal materials that has been announced as EU-GMP or EU-GMP equivalent compliant may continue to maintain its compliance with Good Manufacturing Practices under EU-GMP or EU-GMP equivalent principles and standards in one of the following cases:

- It has submitted a dossier requesting public disclosure of an update on the validity of the EU-GMP or EU-GMP equivalent Certificate;

- The manufacturer of medicinal products or medicinal materials provides the results of its self-lookup of information on the website or English-language database of the competent authority on the inspection of compliance with Good Manufacturing Practices. The lookup must be performed after the expiry date of the validity of the compliance with Good Manufacturing Practices that has been announced on the portal of the Ministry of Health and the website of the Receiving Authority. The self-lookup results must be stamped with the confirmation seal of the manufacturer of medicinal products and medicinal materials, enclosed with a document providing the lookup link;

d) The manufacturer of medicinal products and medicinal materials as prescribed at Point c of this Clause shall take full accountability before the law for the legality and accuracy of these documents and information and its self-lookup results. Agencies and organizations using the looked-up information shall perform the lookup and verification using the link provided by the manufacturer of medicinal products and materials.”

Article 9. Amending and supplementing Article 12

“Article 12. Examination, special inspection, surveillance inspection of compliance with Good Manufacturing Practices

1. Examination of manufacturers’ GMP compliance shall comply with the law on specialized inspections.

2. The Receiving Authority shall conduct a special inspection of GMP compliance by a manufacturer in one of the following cases:

a) The manufacturer undergoes a change prescribed in Clause 5, Article 11 of this Circular, where the change report does not sufficiently demonstrate the maintenance of GMP compliance by the manufacturer;

b) The manufacturer has had at least 01 batch of medicinal products recalled due to a level 1 violation;

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

d) The manufacturer has inspection results concluded by a competent authority as showing serious violations of GMP principles and standards;

dd) Complaints or denunciations are received alleging that a manufacturer has seriously violated GMP principles and standards;

e) The manufacturer fails to submit the report on operations and maintenance of GMP compliance as prescribed in Clause 5, Article 9 of this Circular;

g) A manufacturer of non-prescription chemical medicinal products is manufacturing herbal medicinal products, traditional medicinal products, or health supplements;

h) The manufacturer experiences incident and abnormal signs, or well-founded complaints or denunciations are received in writing, through the hotline for receiving feedback and complaints, or from the mass media.

3. Surveillance inspection of compliance with GMP principles and standards:

a) The Receiving Authority shall conduct a special inspection at least once every 03 years from the end date of the previous inspection for the following manufacturers:

- Manufacturers or production lines complying with GMP at level 3 as prescribed at Point c, Clause 3, Article 7 of this Circular, after completing the corrective actions and being concluded by the Receiving Authority as GMP-compliant.

- Manufacturers or production lines complying with GMP at level 4 as prescribed at Point d, Clause 3, Article 7 of this Circular, after being permitted to resume manufacturing operations in accordance with Point b of this Clause.

- Manufacturers assessed by the Receiving Authority as having risks related to GMP compliance;

b) A manufacturer or production line complying with GMP at level 4 must suspend manufacturing operations within the non-compliant scope according to the written notice of the Receiving Authority prescribed in Clause 4, Article 10 of this Circular. The manufacturer may resume manufacturing operations only after completing the corrective actions, submitting a corrective action report to the Receiving Authority, and being inspected on-site and concluded by the Receiving Authority as GMP-compliant.

4. The composition of the Inspection Team shall be decided by the Head of the Receiving Authority in accordance with Article 18 of this Circular.

5. ‘The procedures for special inspection and surveillance inspection of GMP compliance by manufacturers shall comply with Article 7 of this Circular.

6. The handling of results of examination, special inspection and surveillance inspection of GMP compliance by manufacturers shall comply with the law.”

Article 10. Amending and supplementing Clause 2, Article 13

“2. A manufacturer that is not subject to the issuance of a Certificate of Eligibility for Pharmaceutical Business (excluding the preparation department of a healthcare establishment); or a healthcare establishment manufacturing radiopharmaceuticals, shall submit a written request for GMP compliance inspection using Form No. 01 in Appendix X to this Circular, together with the technical documents on the manufacturer prepared in accordance with the guidance on the Site Master File in Appendix VIII to this Circular for an initial inspection, or a report on manufacturing operations and maintenance of GMP compliance by the manufacturer, accompanied by updated technical documents on the manufacturer (if any changes have been made), as prescribed in Clause 3, Article 9 of this Circular for a routine inspection.”

Article 11. Amending and supplementing Point b, Clause 3, Article 17

“b) The certified scope stated on the GMP Certificate/manufacturing license or the GMP inspection report, or the documents prescribed in Clause 5, Article 97 of Decree No. 163/2025/ND-CP;”

Article 12. Amending and supplementing Point d, Clause 2, Article 18

“d) Members who are experts from universities with expertise relevant to the subject matter and scope of the inspection.

Where necessary, based on the nature and subject matter of the inspection, the Receiving Authority shall report to the competent authority for consideration and decision on inviting representatives of relevant agencies and organizations to participate in the Inspection Team.”

Article 13. Amending and supplementing a number of clauses of Article 23

1. To amend and supplement Point a, Clause 2, Article 23 as follows:

“a) Assume the prime responsibility for, and coordinate with relevant units in, disseminating, guiding, and implementing this Circular to manufacturers and traders of herbal medicinal materials and traditional medicinal products and relevant organizations within their management scope;”

2. To add Clause 2a following Clause 2, Article 23 as follows:

“2a. The Vietnam Food Administration shall be responsible for:

a) Assuming the prime responsibility for, and coordinating with relevant units in, disseminating, guiding, and implementing the provisions of this Circular to manufacturers of medicinal products that also manufacture health supplements and relevant organizations within their management scope;

b) Assuming the prime responsibility for inspecting compliance with Good Manufacturing Practices principles and standards for the manufacture of health supplements on the production lines of medicinal product manufacturers that also manufacture health supplements, in accordance with Article 4 of this Circular;

c) Coordinating with the Drug Administration of Vietnam and the Traditional Medicine Administration of Vietnam in assessing and inspecting compliance with Good Manufacturing Practices by the manufacturers prescribed at Point b of this Clause within the assigned tasks and powers.”

3. To amend and supplement Clause 5, Article 23 as follows:

“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;

d) Ensuring coordination with, and not obstructing, the inspection and assessment by the GMP Inspection Team;

dd) Manufacturers of finished and bulk medicinal products shall, according to the intended use and scope of application of the excipients, conduct self-inspections to verify that the excipients used at their sites comply with the GMP principles and standards prescribed at Point dd, Clause 1, Article 3 and Point b, Clause 3, Article 3 of this Circular;

e) A manufacturer of medicinal products that also manufactures health supplements or bulk health supplements as prescribed in Article 4 of this Circular must fully comply with this Circular and relevant laws on the management of health supplements, and report on the manufacture of medicinal products, medicinal materials, herbal medicinal products, traditional medicinal products, and health supplements to the Drug Administration of Vietnam, the Traditional Medicine Administration of Vietnam, and the Vietnam Food Administration in accordance with regulations.

The manufacturer shall report its manufacture of health supplements to the Receiving Authority prescribed in Article 6 of this Circular and the Vietnam Food Administration before manufacturing health supplements in the cases prescribed in Article 4 of this Circular;

g) Healthcare establishments manufacturing radiopharmaceuticals shall implement the GMP principles and standards applicable to the manufacture of radiopharmaceuticals in healthcare establishments, in accordance with the roadmap prescribed in this Circular.”

Article 14. Amending and supplementing a number of Appendices

1. To amend Appendices VI, VII, IX, X, XI to this Circular.

2. To add Appendix XII on the Good Manufacturing Practices principles and standards recommended by the World Health Organization (WHO-GMP) for the manufacture of investigational medicinal products and medicinal products used in clinical trials, and Appendix XIII on the Good Manufacturing Practices principles and standards for the manufacture of radiopharmaceuticals at healthcare establishments to this Circular.

Article 15. Responsibilities for implementation organization and implementation provisions

1. This Circular takes effect on January 01, 2027.

2. To amend Point c, Clause 1, Article 7 of Circular No. 18/2019/TT-BYT of the Minister of Health guiding Good Manufacturing Practices (GMP) in the manufacture and trading of health supplements as follows:

“c) Assume the prime responsibility for inspecting compliance with Good Manufacturing Practices principles and standards for the manufacture of health supplements on the production lines of medicinal product manufacturers that also manufacture health supplements; coordinate with the Drug Administration of Vietnam and the Traditional Medicine Administration of Vietnam in assessing and inspecting compliance with Good Manufacturing Practices by medicinal product manufacturers that also manufacture health supplements within the assigned tasks and powers.”

3. Transitional provisions:

a) For dossiers of application for Certificates of Eligibility for Pharmaceutical Business, dossiers of application for GMP compliance inspection or routine inspection of compliance with Good Manufacturing Practices for medicinal products and medicinal materials, and change reports that were submitted to the Receiving Authority before the effective date of this Circular, the Receiving Authority shall continue the inspections in accordance with Circular No. 28/2025/TT-BYT, or in accordance with this Circular if the manufacturers so request;

b) No later than November 01, 2028, healthcare establishments manufacturing radiopharmaceuticals must comply with the Good Manufacturing Practices principles and standards for the manufacture of radiopharmaceuticals in healthcare establishments, as prescribed in Appendix XIII to this Circular.

4. The Chief of the Ministry Office; the Director of the Drug Administration of Vietnam; the Director of the Traditional Medicine Administration of Vietnam; the Director of the Vietnam Food Administration; heads of units under and affiliated with the Ministry of Health; Directors of the Departments of Health of provinces and cities; heads of health agencies of ministries and sectoral authorities; heads of healthcare establishments and relevant agencies, organizations, and individuals shall be responsible for implementing this Circular.

5. In the course of implementation, should any difficulties or problems arise, authorities, organizations, and individuals are requested to report to the Ministry of Health (the Drug Administration of Vietnam, the Traditional Medicine Administration of Vietnam, or the Vietnam Food Administration) for consideration and resolution./.