Circular No. 35/2018/TT-BYT on Good Manufacturing Practice (GMP) for Drug Production and Active Pharmaceutical Ingredients.

CIRCULAR

PROVISIONS ON GOOD MANUFACTURING PRACTICES FOR MEDICINES AND MEDICINE INGREDIENTS

Pursuant to Law No. 105/2016/QH13 on April 6, 2016 regarding pharmaceuticals; 005/2016/QH13 dated April 6, 2016 on pharmaceuticals;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some articles and bimplementing mechanisms of the Medicine Law;

Pursuant to Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions within the scope of management of the Ministry of Health;i Pursuant to Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration, the Director of the Traditional Medicine and Drug Administration,

The Minister of Health issues this Circular on Good Manufacturing Practices for Medicines and Medicine Ingredients.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the announcement of application, issuance, and assessment of compliance with Good Manufacturing Practices for Medicines and Medicine Ingredients.

Article 2. Interpretation of Terms

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

1. Good Manufacturing Practices for medicines is a set of principles and standards for the production of medicines and medicine ingredients aimed at ensuring that medicines and medicine ingredients are consistently produced and tested according to appropriate quality standards suitable for their intended use and the requirements of the drug registration certificate.

2. Production facility (including chemical drug production facilities, herbal drug production facilities, vaccine production facilities, biological product production facilities, traditional medicine production facilities, traditional medicine ingredient production facilities, and medicine ingredient production facilities) is a facility engaged in pharmaceutical activities that require or do not require a Pharmaceutical Business Operation Permit, which implements one, several, or all stages of the process of producing medicines and medicine ingredients.

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

4. GMP stands for "Good Manufacturing Practices," which is translated into Vietnamese as "Good Manufacturing Practices."

5. WHO stands for "World Health Organization," which is translated into Vietnamese as "World Health Organization."

6. WHO-GMP stands for "Good Manufacturing Practices of the World Health Organization."

7. PIC/S stands for "Pharmaceutical Inspection Co-operation Scheme," which is translated into Vietnamese as "Pharmaceutical Inspection Cooperation System."

8. PIC/S-GMP stands forI"Good Manufacturing Practices of the Pharmaceutical Inspection Cooperation System." 9. EU stands for

"European Union," which is translated into Vietnamese as "European Union." 10. EU-GMP stands for

"Good Manufacturing Practices of the European Union." US

11. stands for "United States," which is translated into Vietnamese as "United States" are 12. SRA stands for

"Stringent Regulatory Agency," which is translated into Vietnamese as "Strict Regulatory Agency" according to the definition of WHO. ANNOUNCEMENT OF APPLICATION, ISSUANCE OF GOOD MANUFACTURING PRACTICES FOR MEDICINES AND MEDICINE INGREDIENTS

Chapter II

Article 3. Documents on principles and standards of Good Manufacturing Practices for medicines and medicine ingredients

1. Announce the application of the following principles and standards of Good Manufacturing Practices for medicines and medicine ingredients:

a) Principles and standards of Good Manufacturing Practices for medicines of the World Health Organization as specified in Appendix I attached hereto and updated documents as provided for in Clause 3 of this Article;

b) Principles and standards of Good Manufacturing Practices for blood and plasma-derived biological medicines of the World Health Organization as specified in Appendix II attached hereto and updated documents as provided for in Clause 3 of this Article;

c) Principles and standards of Good Manufacturing Practices for medicines of the Pharmaceutical Inspection Cooperation Scheme as specified in Appendix III attached hereto and updated documents as provided for in Clause 3 of this Article;

d) Principles and standards of Good Manufacturing Practices for medicines of the European Union as specified in Appendix IV attached hereto and updated documents as provided for in Clause 3 of this Article.

2. Issue the following principles and standards of Good Manufacturing Practices for medicines and medicine ingredients:

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

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

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

3. In addition to the GMP principles and standards specified in Clauses 1 and 2 of this Article, other equivalent GMP principles and standards issued by strict regulatory agencies (SRA) countries may be applied. Production facilities applying these principles and standards shall be responsible for translating and confirming the translation in accordance with the law on notarization and authentication, and submitting it to the Drug Administration for publication on the Ministry of Health's website and the Drug Administration's website.

4. In case the World Health Organization, the Pharmaceutical Inspection Cooperation Scheme, the European Union, or strict regulatory agencies (SRA) countries amend or supplement the principles and standards of Good Manufacturing Practices for medicines and medicine ingredients (hereinafter referred to as updated documents) as specified in Clause 1 of this Article, within six months from the date of publication of the updated documents on the websites of these organizations, the Drug Administration shall organize the translation and announce the amended and supplemented contents on the Ministry of Health's website and the Drug Administration's website for relevant parties to search, update, and apply.

4. In case the World Health Organization, the Pharmaceutical Inspection Co-operation Scheme, the European Union, or the drug regulatory authorities of SRA countries amend or supplement the Good Manufacturing Practice principles and standards for medicines and active pharmaceutical ingredients (hereinafter referred to as updated documents) as stipulated in Clause 1 of this Article, within six months from the date these updated documents are published on the websites of the respective agencies, the Drug Administration shall organize their translation and publication on the Ministry of Health's website and the Drug Administration's website, as well as the Traditional Medicine Administration's website, for relevant parties to search, update, and apply.

Article 4. Apply principles and standards of Good Manufacturing Practice (GMP) for drug production and raw materials

1. Drug manufacturing facilities and raw material manufacturing facilities shall implement GMP as specified in Appendix I, Appendix III, or Appendix IV attached hereto and updated documents as provided for in Clause 4, Article 3 of this Circular.

2. Biological drug manufacturing facilities derived from human blood and plasma shall implement GMP as specified in Appendix II attached hereto and updated documents as provided for in Clause 4, Article 3 of this Circular.

3. Traditional herbal medicine manufacturing facilities shall implement GMP as specified in Appendix V attached hereto.

4. Traditional medicine manufacturing facilities that only produce traditional medicines in the form of decoctions, powders, pills, and granules shall implement GMP as specified in Part I of Appendix VI attached hereto.

5. Traditional medicine manufacturing facilities producing modern dosage forms (capsules, tablets, suspensions, syrups, and other modern dosage forms) not covered under Clause 4 of this Article shall implement GMP as specified in Part II of Appendix VI attached hereto.

6. Traditional herb manufacturing facilities shall implement GMP as specified in Appendix VII attached hereto.

7. Drug manufacturing facilities and raw material manufacturing facilities implementing other GMP principles and standards equivalent to EU-GMP, issued by the drug regulatory authorities of SRA countries and updated documents as provided for in Clause 4, Article 3 of this Circular, may be applied.

8. Traditional herbal medicine manufacturing facilities, traditional medicine manufacturing facilities, and traditional herb manufacturing facilities shall implement GMP as specified in Appendix I, Appendix III, or Appendix IV attached hereto and updated documents as provided for in Clause 4, Article 3 of this Circular.

9. Traditional medicine manufacturing facilities and traditional herb manufacturing facilities may implement GMP as specified in Part II of Appendix VI, Appendix I, Appendix III, or Appendix IV attached hereto and updated documents as provided for in Clause 4, Article 3 of this Circular.

10. Drugs and raw materials containing beta-lactam antibiotics (Penicillins, Cephalosporins, Penems, and similar), cytotoxic/cytostatic drugs, drugs containing sex hormones with contraceptive effects, vaccines, biological products, and other drugs requiring separate production according to GMP principles and standards must be produced in separate facilities and equipment and measures to prevent contamination and cross-contamination with other products manufactured in the same area must be ensured, in addition to being produced at facilities implementing corresponding GMP as stipulated in this Article.

11. Chemical drug manufacturing facilities producing soft capsules, oral liquids, topical preparations (creams, gels, ointments, and topical liquids) using standardized herbal extracts, decoctions, and powders on corresponding production lines must implement GMP as specified in Appendix I, Appendix III, or Appendix IV attached hereto and updated documents as provided for in Clause 4, Article 3 of this Circular.

13. Traditional medicine manufacturing facilities producing traditional medicines supplemented with purified components extracted from essential oils, vitamins, and minerals must implement GMP as specified in Appendix VI attached hereto.

14. Facilities undertaking one or more stages of the drug and raw material manufacturing process must implement and comply with GMP requirements corresponding to the manufacturing stage as specified in Clauses 1, 2, 3, 4, and 5 of this Article.

15. Drug manufacturing facilities and raw material manufacturing facilities must implement updated GMP documents as provided for in Clause 3, Article 3 of this Circular within the following timeframes:

a) 12 months for cases requiring changes to production facilities and equipment, calculated 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, calculated from the date the updated documents are published on the Ministry of Health's website and the Drug Administration of Vietnam's website.

ASSESSMENT OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICE FOR DRUGS AND RAW MATERIALS

Chapter III

ASSESSMENT OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICE FOR MEDICINES AND ACTIVE PHARMACEUTICAL INGREDIENTS

Article 5. Documents serving as the basis for evaluating compliance with Good Manufacturing Practices (GMP) for drug production and raw materials

1. The documents serving as the basis for evaluating compliance with GMP for pharmaceutical business establishments are the application documents for obtaining a Business Registration Certificate for Pharmaceutical Activities (submitted when applying for a Business Registration Certificate for Pharmaceutical Activities, manufacturing establishments do not need to submit additional documents for GMP compliance evaluation) in accordance with Article 38 of the Drug Law and Article 32 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Drug Law (hereinafter referred to as Decree No. 54/2017/ND-CP). For drug manufacturing establishments that require special supervision, the provisions of Article 38 of the Drug Law and Clause 31 of Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/ND-CP) shall be followed.

Technical documents on the manufacturing facility must be presented according to the overall dossier guidelines for the manufacturing facility as stipulated 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 manufacturing establishment applies for both a GMP Certificate and a Business Registration Certificate for Pharmaceutical Activities, the establishment must clearly state this in the Application for a Business Registration Certificate for Pharmaceutical Activities and specify the applicable GMP principles and standards at the facility.

3. In cases where a manufacturing establishment applies for a Business Registration Certificate for Pharmaceutical Activities while selling drugs and raw materials produced by the establishment to wholesalers, retailers, and healthcare facilities, if it also applies for a Certificate demonstrating compliance with Good Distribution Practices (GDP) for drugs and raw materials together with the Business Registration Certificate for Pharmaceutical Activities in the Application Form and submits additional technical and personnel documents as required by Clause 2 of Article 32 of Decree No. 54/2017/ND-CP, the receiving authority will simultaneously evaluate compliance with GDP during the assessment of GMP compliance of the establishment in accordance with relevant laws on Good Distribution Practices for drugs and raw materials.

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

1. Receiving documents:

A manufacturing establishment must submit one set of documents in accordance with Article 5 of this Circular along with the review fee as prescribed by the Minister of Finance regarding the review fee for production standards and conditions to the receiving authority of the Ministry of Health as follows:

a) The Traditional Medicine Management Department for manufacturing establishments applying for a Business Registration Certificate for Pharmaceutical Activities with a scope limited to producing traditional medicinal herbs, traditional medicines, and traditional herbal medicines at the time of submitting the application;

b) The Drug Administration Department for manufacturing establishments applying for a Business Registration Certificate for Pharmaceutical Activities with a scope of producing raw materials for drugs (excluding medicinal herbs), chemical drugs, herbal drugs, vaccines, and biological products;

c) The Drug Administration Department for manufacturing establishments applying for a Business Registration Certificate for Pharmaceutical Activities with a concurrent scope of producing one of the types of drugs or raw materials specified in point a of this clause and one of the types of drugs or raw materials specified in point b of this clause at the time of submitting the application.

2. Procedures for receiving and evaluating documents:

Implementation in accordance with Clause 2 and Clause 5 of Article 33 of Decree No. 54/2017/ND-CP and Clause 12 of Article 5 of Decree No. 155/2018/ND-CP.

3. Within five days from the date of receipt of valid documents, the receiving authority shall establish an Evaluation Team and send the establishment a decision establishing the Evaluation Team, including a proposed schedule for the actual on-site evaluation.

Within fifteen days from the date of issuance of the decision, the Evaluation Team shall conduct the on-site evaluation at the manufacturing establishment.

Article 7. Procedure for evaluating compliance and classifying compliance with Good Manufacturing Practice (GMP) for drug production and raw material production

1. Principles for using GMP documentation in evaluating GMP compliance:

a) The principle and standard GMP documents published by the production facility and recorded on the Application Form for Issuance of Certificate of Eligibility to Operate in Pharmaceuticals.

b) The principle and standard EU-GMP or PIC/S-GMP documents or the GMP documents specified in Clause 3 of Article 3 of this Circular for cases where the production facility has been evaluated and certified as compliant with GMP by the Drug Regulatory Authority (SRA) and requests publication of its compliance with these GMP standards.

c) The principle and standard WHO-GMP documents or the GMP documents stipulated in Clauses 2, 3, 4, 5, and 6 of Article 4 of this Circular corresponding to the production activities for cases where the production facility does not clearly specify the applicable GMP principles and standards in the Application Form for Issuance of Certificate of Eligibility to Operate in Pharmaceuticals.

2. Evaluation procedure:

a) Step 1. The evaluation team announces the Decision to establish the Evaluation Team, purpose, content, and plan for the evaluation at the production facility.

b) Step 2. The production 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 actual assessment of the implementation and application of GMP at the production facility according to specific content. In cases where the facility performs one or several stages of the production process, the assessment content only includes requirements corresponding to one or several production stages performed by the facility.

d) Step 4. The evaluation team meets with the production facility to inform about any issues discovered during the evaluation (if any); assess the severity of each issue; discuss with the production facility if it disagrees with the evaluation team's assessment of each issue or regarding the level of compliance with GMP principles and standards of the production facility.

e) Step 5. Drafting and signing the assessment record:

Immediately after completing the on-site evaluation at the production facility, the evaluation team prepares an evaluation report according to Model No. 03 prescribed in Appendix X issued together with this Circular. The evaluation report must reflect the composition of the evaluation team, the composition of the production facility, location, time, scope of the evaluation, and unresolved issues between the evaluation team and the production facility (if any). The head of the production facility and the Head of the Evaluation Team sign to confirm the evaluation report. The report is made in three copies: one copy retained by the production facility, two copies retained by the receiving agency.

f) Step 6. Completing the Assessment Report:

The evaluation team is responsible for preparing a GMP evaluation report according to Model No. 04 prescribed in Appendix X issued together with this Circular, listing and analyzing, classifying the severity levels of issues that the production facility needs to address and correct; referencing relevant legal provisions and GMP principles and standards, assessing the level of GMP compliance of the production facility. The classification of severity levels and assessment of GMP compliance of the production facility (specifically for each production line) is defined in Appendix IX issued together with this Circular.

3. Levels of GMP Compliance:

The levels of GMP compliance of the production facility specified in Appendix IX issued together with this Circular include the following levels:

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

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

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

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

Article 8. Handling the Results of Good Manufacturing Practice (GMP) Compliance Assessment for Pharmaceutical Production and Raw Materials

1. In the case where 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:

Within ten working days from the date of signing the assessment record, the Receiving Authority shall submit to the Minister of Health for issuance of the Business Registration Certificate for Drug Trading and implement the issuance of the GMP Certificate according to Form No. 05 prescribed in Appendix X attached to this Circular if the production facility has requested it in the Application for Issuance of the Business Registration Certificate for Drug Trading.

2. In the case where 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 signing the assessment record, the Receiving Authority shall send the GMP assessment report to the production facility in accordance with point b, Clause 6, Article 33 of Decree No. 54/2017/NĐ-CP.

b) After completing the corrective actions, the production facility must submit a written report on corrective actions including a plan and evidence (document files, images, videos, certificates, or other proof documents) demonstrating the completion of the corrective actions recorded in the GMP assessment report.

c) Within twenty days from the date of receiving the written report on corrective actions, the Receiving Authority shall evaluate the results of the corrective actions of the production facility and conclude on the GMP compliance status of the production facility:

- If the corrective actions of the production facility meet the requirements: The Receiving Authority shall submit to the Minister of Health for issuance of the Business Registration Certificate for Drug Trading and implement the issuance of the GMP Certificate according to Form No. 05 prescribed in Appendix X attached to this Circular if the production facility has requested it in the Application for Issuance of the Business Registration Certificate for Drug Trading;

- If the corrective actions of the production facility do not meet the requirements: The Receiving Authority shall issue a written notice to the production facility specifying the reasons.

d) Within six months from the date the Receiving Authority sends the GMP assessment report containing the requirement for amendments and supplements, the production facility must submit the amended and supplemented dossier. After this period, if the production facility does not amend or supplement the dossier or if the amended and supplemented dossier submitted within twelve months from the first application submission does not meet the requirements, the submitted application will lose its validity.

3. In the case where 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:

The procedures and time limits for handling the results of the GMP compliance assessment are regulated in Clause 2 of this Article.

Within twenty days from the date of receiving the written report on corrective actions, the Receiving Authority 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 stipulated in point c, Clause 2 of this Article.

4. In the case where 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 signing the assessment record, the Receiving Authority shall issue a written notice regarding non-compliance with GMP along with the GMP assessment report to the production facility and will not issue the Business Registration Certificate for Drug Trading.

5. In the case where the production facility disagrees with the findings of the assessment team, within thirty days from the date the assessment team issues the GMP assessment report or the corrective action assessment report, the production facility must submit a written objection to the Receiving Authority accompanied by evidence (document files, images, videos, certificates) related to the findings.

Within ten working days from the date of receiving the production facility's written objection, the Receiving Authority shall review the GMP assessment report, the content of the production facility's objection, seek expert opinions if necessary, and issue a written response to the production facility. The response must clearly state whether the objection is accepted or rejected and provide reasons for rejection. This time does not count towards the assessment period.

6. Within five working days from the date of issuing the Business Registration Certificate for Drug Trading, the Receiving Authority shall publish on the Ministry of Health’s Electronic Information Portal and the Receiving Authority’s Electronic Information Portal the following information:

a) Name and address of the production facility;

b) Name of the person responsible for drug specialty, the person in charge of quality assurance, and the Drug Practitioner License number;

c) Number of the Business Registration Certificate for Drug Trading and the GMP Certificate (if applicable);

d) Expiry date of the GMP compliance assessment;

đ) Scope of operation of the production facility.

e) EU-GMP Certificate number, validity period, and issuing authority for production facilities evaluated by the SRA drug management agency as meeting EU-GMP or equivalent standards.

Chapter IV

ASSESSMENT OF THE MAINTENANCE OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICE FOR PHARMACEUTICAL PRODUCTION AND RAW MATERIALS

Article 9. Periodic Assessment of Compliance with Good Manufacturing Practices for Medicines and Active Pharmaceutical Ingredients

1. The periodic assessment period for compliance with GMP at production facilities is three years, starting from the date of signing the evaluation report of the previous inspection (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 publishes on its Electronic Information Website the plan for the upcoming year's periodic assessments of GMP compliance for production facilities and sends this plan to the facilities listed in the plan. For production facilities specified in point c, Clause 1, Article 6 of this Circular, the Drug Administration of Vietnam will publish and implement the periodic assessment plan, except when the facility requests a separate assessment.

3. At least thirty days before the scheduled periodic assessment date announced by the Receiving Agency, the production facility must submit to the Receiving Agency a report on its pharmaceutical manufacturing activities and GMP compliance (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).

Example: If the planned periodic assessment date at Production Facility A is August 18, 2018, then Production Facility A must submit the activity-compliance report to the Receiving Agency by July 18, 2018.

4. In cases where a production facility fails to submit the activity-compliance report within the time frame specified in Clause 3 of this Article, the Receiving Agency shall issue a written request to the facility to submit the report within fifteen days from the due date.

5. Within forty-five days from the date the Receiving Agency issues the request, the production facility must submit the activity-compliance report along with an explanation for the delay. If the facility fails to submit the report after this period, the Receiving Agency will conduct an unscheduled inspection, audit, or check of GMP compliance according to Article 12 of this Circular.

6. After submitting the activity-compliance report within the prescribed timeframe, the production facility may continue its pharmaceutical manufacturing operations within the scope defined in the Certificate of Eligibility for Pharmaceutical Business until the results of the periodic GMP compliance assessment are available, while ensuring ongoing compliance with GMP standards.

7. The procedures for conducting the assessment, the assessment process, and classification of GMP compliance results shall be carried out according to the provisions of Articles 6 and 7 of this Circular.

Article 10. Handling Results of Periodic Assessments of Compliance with Good Manufacturing Practices for Medicines and Active Pharmaceutical Ingredients

1. In the case where 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:

Within ten working days from the date of signing the assessment report, the Receiving Agency updates information about the facility's GMP compliance on the Ministry of Health's Electronic Information Portal and the Receiving Agency's Electronic Information Website according to Clause 6, Article 8 of this Circular, and issues the GMP Certificate according to Form No. 05 stipulated in Appendix X attached to this Circular for facilities requesting the GMP Certificate.

2. In the case where 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 signing the assessment report, the Receiving Agency sends the GMP assessment report to the production facility for corrective actions and submits the corrective action report back 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 (documentation, images, videos, certificates, or other proof) demonstrating the corrections made based on the GMP assessment report.

c) Within twenty days from the date of receiving the written report on corrective actions, the Receiving Authority shall evaluate the results of the corrective actions of the production facility and conclude on the GMP compliance status of the production facility:

- If the corrective actions taken by the facility meet the requirements: The Receiving Agency updates the facility's GMP compliance information on the Ministry of Health's Electronic Information Portal and the Receiving Agency's Electronic Information Website according to Clause 6, Article 8 of this Circular, and issues the GMP Certificate according to Form No. 05 stipulated in Appendix X attached to this Circular for facilities requesting the GMP Certificate.

- If the corrective actions taken by the facility do not meet the requirements: The Receiving Agency issues a notice specifying the necessary further corrective actions and submission of additional reports. The extended period for further corrective actions and reporting is forty-five days from the issuance of the notice.

d) Within ninety days from the date of signing the assessment report, if the production facility does not submit a corrective action report or if the corrective actions taken according to point c of this Clause still fail to meet the requirements, the Receiving Agency issues a notice of non-compliance with GMP and implements one or more measures according to points a and b of Clause 4 of this Article depending on the nature and severity of the violation.

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

The procedures and time limits for handling the results of the GMP compliance assessment are regulated in Clause 2 of this Article.

Within twenty days from receiving the corrective action report, the Receiving Agency conducts a supervisory inspection of the corrective actions at the production facility before concluding the facility's GMP compliance status according to point c, Clause 2 of this Article.

4. In the case where 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 signing the assessment report, based on the risk assessment of the quality of medicines and active pharmaceutical ingredients and the safety of drug users, the Receiving Agency issues 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 may take one or more of the following actions:

a) Administrative penalties according to laws on administrative violations.

b) Submit to the Minister of Health for a decision to revoke the Business Registration Certificate for Pharmaceutical Operations issued in accordance with Clause 2, Article 40 of the Drug Law, and recover the Good Manufacturing Practice (GMP) Certificate issued (if any).

c) In cases where the production facility does not meet one or more business scopes specified in the Business Registration Certificate for Pharmaceutical Operations already issued, the Receiving Authority shall:

- Submit to the Minister of Health for a decision to revoke the Business Registration Certificate for Pharmaceutical Operations already issued to remove the non-compliant business scope in accordance with Article 40 of the Drug Law, and simultaneously issue a new Business Registration Certificate for Pharmaceutical Operations that matches the compliant business scope of the production facility;

- Issue a new GMP Certificate that corresponds to the compliant business scope if requested by the production facility.

5. Within five working days from the date of conclusion that the production facility maintains GMP compliance or from the date of issuance of the decision to revoke the Business Registration Certificate for Pharmaceutical Operations due to non-compliance with GMP, the Receiving Authority shall update the GMP compliance status on the Receiving Authority's Electronic Information Website in accordance with the provisions of Clause 6, Article 8 of this Circular for production facilities maintaining GMP compliance, or information about the revocation of the Business Registration Certificate for Pharmaceutical Operations and GMP Certificate (if any) for production facilities failing to maintain GMP compliance.

6. In cases where drug samples or raw materials for drugs collected during the evaluation process are found to be in violation of quality standards, the Receiving Authority shall handle the violative drugs and raw materials for drugs in accordance with current regulations.

Article 11. Change Control

1. A vaccine production facility must submit a notification letter accompanied by a risk assessment and impact analysis of the proposed changes on product quality and safety before implementing changes as stipulated 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 or trial-producing vaccines or other pharmaceutical products on a vaccine production line that has been certified.

Within fifteen days, the Drug Administration shall provide a written response if it disagrees with the proposed change by the vaccine production facility.

2. After implementing changes, the production facility must apply for a new Business Registration Certificate for Pharmaceutical Operations or submit a change report according to Form No. 06 prescribed in Appendix X attached to this Circular if the changes fall under any of the following circumstances:

a) Changes as stipulated in Point b of Clause 1, Article 36 of the Drug Law;

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

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

d) Expanding the existing manufacturing plant based on its current structure;

đ) Repairing or making significant structural and layout changes to the factory buildings and production lines that alter the production environment and processes;

e) Replacing major production equipment that affects the production process and the quality of drugs and raw materials for drugs;

g) Modifying auxiliary systems or changing their design principles and operation methods that affect the production environment;

h) The production facility changes the applied GMP standards, which have been evaluated and certified by the Competent Authority to meet EU-GMP or equivalent standards (Japan-GMP, US-Current GMP, PIC/S-GMP), and requests publication of this compliance.

3. If the production facility undergoes changes as stipulated in Point b of Clause 2 of this Article, the production facility must submit an application for a new Business Registration Certificate for Pharmaceutical Operations in accordance with Clauses 2 and 4 of Article 38 of the Drug Law.

The procedures for evaluating GMP compliance, classifying results, and handling evaluation outcomes are carried out in accordance with Articles 6, 7, and 8 of this Circular.

4. If the production facility undergoes changes as stipulated in Points b, c, d, or h of Clause 2 of this Article, or if a sterile drug or raw material for drugs production facility undergoes changes as stipulated in Point đ of Clause 2 of this Article, the production 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 production facility meets the requirements, the Receiving Authority issues a written agreement with the changes made by the production facility;

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

5. If the production facility undergoes changes as stipulated in Point h of Clause 2 of this Article, the production facility must submit a notification letter regarding the change in applied GMP standards and the inspection and evaluation conducted by the Competent Authority (name of the Competent Authority, evaluation period, scope/content of the evaluation, evaluation results) along with corresponding technical documentation, GMP certificate/confirmation of GMP compliance, or GMP audit report issued by the Competent Authority.

a) The Receiving Authority shall review the notification and accompanying documents, and supplement/update the information on the production facility's compliance with EU-GMP or equivalent standards in accordance with Clause 6, Article 8 of this Circular.

b) The Receiving Authority shall evaluate the maintenance of compliance with EU-GMP or equivalent standards at the production facility in accordance with Article 12 of this Circular.

6. If the production facility undergoes changes as stipulated in Points đ, e, or g of Clause 2 of this Article (excluding the circumstances stipulated in Clauses 4 and 6 of this Article), the production facility must submit a change report along with corresponding technical documentation to the Receiving Authority. The Receiving Authority shall evaluate the change report submitted by the production facility.

a) Within ten working days from the date of receiving the notification document from the production facility, the Agency shall issue a notification document agreeing to the change content if the change meets the requirements, or notify the content that needs to be rectified or corrected if it does not meet the requirements;

b) Within forty-five days from the date the Agency issues the notification document, the production facility must complete the rectification or correction and submit a report document accompanied by evidence (files, documents, images, videos, certificates, and other relevant materials) proving the completion of the rectification or correction mentioned in the notification document;

c) Within ten days from the date of receiving the rectification report from the production facility, accompanied by evidence (files, documents, images, videos, certificates, and other relevant materials), the Agency shall evaluate the rectification results of the production facility and conclude on the compliance status with Good Manufacturing Practices (GMP);

- In case the rectification has met the requirements: The Agency shall issue a notification document agreeing to the change content;

- In case the rectification has not met the requirements: The Agency shall conduct an urgent assessment and handle the assessment results according to Article 12 of this Circular;

7. In cases where a drug manufacturing facility or non-sterile drug ingredient manufacturing facility outside the sterile environment makes changes falling under any of the circumstances specified in points đ, e, and g of Clause 2 of this Article, the facility must submit a change report along with corresponding technical documentation regarding the change to the Agency. The facility must continue to ensure the maintenance of its operations in accordance with GMP principles and standards;

Article 12. Urgent Assessment, Inspection, and Supervision of Compliance with Good Manufacturing Practices for Drug Production and Drug Ingredient Production

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

2. The Agency shall conduct an urgent assessment of the maintenance of GMP compliance at production facilities when the facilities fall under any of the following circumstances:

a) The production facility fails to rectify as required under item 2 of point c of Article 11 of this Circular;

b) A production facility operating at level 3 or level 4 as defined in point c and d of Clause 3 of Article 7 of this Circular must undergo an urgent assessment at least once within three years from the end of the previous assessment period;

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

d) The production facility has drugs recorded with a series of adverse drug reaction reports (ADR) including serious adverse reactions;

đ) The production facility has inspection and supervision results from competent authorities concluding with 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 an operational activity - GMP compliance maintenance report as stipulated in Clause 5 of Article 9 of this Circular;

3. The composition of the Assessment Team shall be decided by the Head of the Agency in accordance with Article 15 of this Circular;

4. The procedure for conducting an urgent assessment at production facilities shall be carried out in accordance with Article 7 of this Circular;

5. Handling the results of inspections, supervisions, and urgent assessments at production facilities shall be conducted in accordance with the provisions of the law;

Chapter V

ASSESSMENT OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICES FOR DRUG PRODUCTION AND DRUG INGREDIENT PRODUCTION BY DOMESTIC PRODUCTION FACILITIES NOT COVERED UNDER THE LICENSE FOR LEGAL DRUG BUSINESS OPERATIONS AND FOREIGN PRODUCTION FACILITIES WHEN REGISTERING DRUGS AND DRUG INGREDIENTS FOR CIRCULATION IN VIETNAM

Article 13. Evaluation of Compliance with Good Manufacturing Practice for Medicines for Production Establishments Not Subject to Issuance of Business Registration Certificate for Medicines

1. Production establishments not subject to issuance of business registration certificate for medicines (establishments that engage in pharmaceutical activities but not for commercial purposes) must comply with GMP as stipulated in Point a Clause 2 Article 35 of the Medicine Law.

2. Production establishments not subject to issuance of business registration certificate for medicines (excluding the compounding unit of medical examination and treatment establishments) shall submit a request for evaluation of compliance with GMP according to Form No. 1 prescribed in Appendix X issued together with this Circular and technical documentation on the pharmaceutical production facility presented in accordance with the overall dossier guidelines for production facilities prescribed in Appendix VIII issued together with this Circular for initial evaluation cases or reports on production activities - maintaining compliance with GMP of the establishment, accompanied by updated technical documentation on the production facility (if there are changes) as stipulated in Clause 3 Article 9 for periodic evaluation cases.

3. The procedures for evaluation, evaluation process, classification of evaluation results, change control, and sudden evaluation of compliance with GMP for pharmaceutical production establishments and raw material production establishments not subject to issuance of business registration certificate for medicines shall be implemented in accordance with the corresponding provisions in Articles 6, 7, 9, 11, and 12 of this Circular.

4. Handling of initial evaluation results of compliance with GMP for pharmaceutical production establishments and raw material production establishments not subject to issuance of business registration certificate for medicines:

a) The procedure and time limit for handling initial evaluation results of compliance with GMP of the production establishment shall be carried out in accordance with Article 8 of this Circular.

b) The receiving agency shall issue a notification on the status of compliance with GMP of the production establishment and publish it on the Ministry of Health's Electronic Information Portal and the receiving agency's Electronic Information Portal as prescribed in Clause 6 of this Article.

5. Handling of periodic evaluation results, sudden inspection and evaluation results of maintenance of compliance with GMP for pharmaceutical production establishments and raw material production establishments not subject to issuance of business registration certificate for medicines:

a) In cases where the inspection and evaluation result concludes that the production establishment complies with GMP at level 1, 2, or 3 as stipulated in Points a, b, and c Clause 3 Article 7 of this Circular, the inspection and evaluation agency shall handle the case in accordance with Clauses 1, 2, and 3 Article 10 of this Circular.

b) In cases where the inspection and evaluation result concludes that the production establishment complies with GMP at level 4 as stipulated in Point d Clause 3 Article 7 of this Circular, the inspection and evaluation agency shall issue a decision to temporarily suspend all production activities or the scope of production activities that do not meet requirements until the establishment implements corrective actions and repairs deficiencies to meet requirements.

c) In cases where the medicine samples or raw material samples taken during the inspection and evaluation are concluded to violate quality standards, the receiving agency shall handle the non-compliant medicines or raw materials in accordance with current regulations on medicine quality management. The head of the production establishment shall bear legal responsibility for such violations.

6. Within five working days from the date of conclusion of compliance/maintenance of compliance with GMP of pharmaceutical production establishments and raw material production establishments not subject to issuance of business registration certificate for medicines, the receiving agency shall publish and update on the Ministry of Health's Electronic Information Portal and the receiving agency's Electronic Information Portal the following information:

a) Name and address of the production facility;

b) Name of the person responsible for drug specialty, the person in charge of quality assurance, and the Drug Practitioner License number;

c) GMP Certificate Number;

d) Expiry date of the GMP compliance assessment;

đ) Scope of operation of the production facility.

e) EU-GMP Certificate Number, validity period, and issuing authority for production establishments that have been evaluated as compliant with EU-GMP or equivalent by the drug regulatory authority SRA (if applicable).

Article 14. Evaluation of Compliance with Good Manufacturing Practices for Medicines and Active Pharmaceutical Ingredients for Foreign Production Facilities Seeking Registration for Circulation in Vietnam

1. A foreign production facility for medicines and active pharmaceutical ingredients must be evaluated and certified to comply with GMP by the competent drug regulatory authority of its home country before submitting an application for GMP compliance evaluation to the Ministry of Health (the receiving agency as stipulated in Clause 1, Article 6 of this Circular).

2. The form of evaluation, content of evaluation, evaluation dossier, procedures, and authority for evaluating compliance with GMP of foreign production facilities shall be carried out in accordance with the provisions of Articles 96, 97, 98, and 99 of Decree No. 54/2017/NĐ-CP.

In cases where the GMP compliance evaluation is conducted through on-site inspection, the evaluation process, classification, handling of evaluation results, and change control shall be implemented in accordance with the provisions of Articles 6, 7, 8, 9, 10, 11, and 12 of this Circular.

3. Within ten working days from the date of receipt of the evaluation result confirming the facility's compliance with GMP, the receiving agency shall publish the following information on the Ministry of Health’s website and the receiving agency’s electronic information portal:

a) Name and address of the production facility;

b) The number of the GMP certificate, the applied GMP documentation, the validity period of the GMP certificate, and the name of the competent foreign drug regulatory authority for the cases specified in point a and b, Clause 5, Article 54 of the Medicine Law, or the date of the GMP compliance evaluation by the Vietnamese Ministry of Health, the applied GMP documentation, and the validity period of the evaluation result for the case specified in point c, Clause 5, Article 54 of the Medicine Law;

c) The scope of activities of the evaluated production facility.

Chapter VI

EVALUATION TEAM FOR COMPLIANCE WITH GOOD MANUFACTURING PRACTICES FOR MEDICINES AND ACTIVE PHARMACEUTICAL INGREDIENTS

Article 15. Composition and Standards for Members of the Evaluation Team

1. The composition of the Evaluation Team includes:

a) The Team Leader 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 Management 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 Control (for vaccine and biomedical product production facilities);

c) One member representing the Provincial Health Department (hereinafter referred to as the Health Department) where the production plant is located;

d) Relevant agency members when necessary.

2. Members participating in the Evaluation Team must meet the following standards:

a) Hold a bachelor's degree or higher and have been trained in medical, pharmaceutical, biological, quality management, and drug administration courses;

b) Have been trained and instructed in GMP, inspection, GMP evaluation, and thoroughly understand GMP principles and standards. Specifically, members participating in the evaluation team for traditional medicine and herbal medicine production facilities must be trained and instructed in GMP for traditional medicine and herbal medicine;

c) Be honest, impartial, and strictly adhere to all regulations and laws during the evaluation process without having any conflict of interest with the evaluated production facility as stipulated in Clause 3 of this Article;

d) The Evaluation Team Leader must have at least three years of experience in drug administration work.

3. Conflict of Interest Evaluation Principle: An Evaluation Team member will be considered to have a conflict of interest with the evaluated production facility if they fall under any of the following circumstances:

a) Have worked or provided consultancy services within the last five years for the evaluated production facility;

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

c) Have a spouse, child, parent, full sibling, parent-in-law, or parent of spouse employed by the evaluated production facility.

Article 16. Responsibilities and Authorities of the Inspection Team

1. Responsibilities of the Inspection Team:

a) To evaluate 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 and technical provisions; record in detail the contents of the evaluation, identified issues, prepare an inspection report, and a GMP Evaluation Report;

b) To report the results of the evaluation or explain the GMP Evaluation Report in cases where the production facility disagrees with the content of the GMP Evaluation Report;

c) To maintain confidentiality over all information related to the evaluation content and all information related to production, quality control, storage, and distribution of drugs (production processes, testing procedures, sanitation, technological secrets, etc.), except when the production facility consents or upon request from authorized state agencies for inspection and investigation purposes;

2. Authorities of the Inspection Team:

a) To 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 the processing and production procedures of traditional herbal medicines at the proposed production facility shall be conducted;

b) To require the provision of documentation related to quality management, production, testing, and storage of drugs and drug ingredients;

c) Collect files and documents, evidence (photocopies of documents, photographs, videos, etc.) regarding issues discovered during the evaluation process;

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

đ) To prepare inspection records, and request the production facility to temporarily suspend one, some, or all activities related to violations. If during the evaluation process, 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;

Chapter VII

IMPLEMENTING PROVISIONS

Article 17. Effective Date

1. This Circular takes effect from January 10, 2019.

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

a) Decision No. 3886/2004/QĐ-BYT dated November 3, 2004, issued by the Minister of Health on the implementation of the principles and standards of "Good Manufacturing Practice for Medicinal Products" as recommended by the World Health Organization;

b) Provisions on Good Manufacturing Practice for Medicinal Products in Decision No. 27/2007/QĐ-BYT dated April 19, 2007, issued by the Minister of Health on the issuance of the roadmap for implementing the principles and standards of "Good Manufacturing Practice for Medicinal Products" and "Good Storage Practice for Medicinal Products";

c) Provisions on Good Manufacturing Practice for Medicinal Products in Circular No. 45/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health amending and supplementing certain articles of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000, issued by the Minister of Health on the implementation of the principles of "Good Laboratory Practice for Pharmaceutical Testing"; Decision No. 2701/2001/QĐ-BYT dated June 29, 2001, issued by the Minister of Health on the implementation of the principles of "Good Storage Practice for Medicinal Products"; Circular No. 06/2004/TT-BYT dated May 28, 2004, guiding the production of pharmaceutical contract manufacturing; Decision No. 3886/2004/QĐ-BYT dated November 3, 2004, issued by the Ministry of Health on the implementation of the principles and standards of "Good Manufacturing Practice for Medicinal Products" as recommended by the World Health Organization; Circular No. 13/2009/TT-BYT dated September 1, 2009, issued by the Ministry of Health guiding advertising activities for medicinal products; Circular No. 22/2009/TT-BYT dated November 24, 2009, issued by the Ministry of Health on the registration of medicinal products; Circular No. 47/2010/TT-BYT dated December 29, 2010, guiding export and import activities of medicinal products and direct contact packaging;

d) Specifically, the provisions on conditions for processing medicinal herbs in Circular No. 03/2016/TT-BYT dated January 21, 2016, issued by the Minister of Health on the operation of herbal medicine business will continue to be effective until December 31, 2020, for cases stipulated in Clause 4, Article 19 of this Circular;

đ) Provision: "If the testing facility does not submit the periodic evaluation application as required, the Ministry of Health will revoke the Certificate of Eligibility for Operating a Drug Business of the testing facility in accordance with Clause 2, Article 40 of the Drug Law" in Clause 5, Article 9 of Circular No. 04/2018/TT-BYT of the Minister of Health dated February 9, 2018 on Good Laboratory Practice

Article 18. 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 19. Transitional Provisions

1. For pharmaceutical production facilities and raw material manufacturing facilities that have been issued a Business Registration Certificate for Pharmaceutical Operations with a scope of pharmaceutical production and raw material manufacturing or a GMP certificate with an effective period still valid, issued before this Circular takes effect, such facilities are permitted to produce pharmaceuticals and raw materials until the expiration date stated on the certificate.

In the case where the Business Registration Certificate for Pharmaceutical Operations expires, the production facility must proceed with the procedures to request issuance of a new Business Registration Certificate for Pharmaceutical Operations in accordance with the law.

In the case where the GMP certificate expires earlier, the production facility must proceed with the procedures to request a maintenance compliance assessment according to Chapter IV of this Circular to continue operations as prescribed.

2. For pharmaceutical production facilities and raw material manufacturing facilities that have been issued a Business Registration Certificate for Pharmaceutical Operations without a time limit, when the GMP certificate expires, the facility must carry out procedures for the competent authority to assess the maintenance of GMP compliance and perform related procedures in accordance with the law.

3. For applications for issuance of a Business Registration Certificate for Pharmaceutical Operations or registration for periodic GMP compliance assessment submitted to the Competent Authority before this Circular takes effect, the Competent Authority will continue to evaluate the production facility according to the Good Manufacturing Practice (GMP) standards issued together with Decision No. 3886/2004/QĐ-BYT dated November 3, 2004 of the Minister of Health regarding the implementation of the "Good Manufacturing Practices for Pharmaceuticals" principles and standards recommended by WHO or according to this Circular if requested by the production facility.

4. For herbal medicine trading facilities engaged in herbal processing activities that have been inspected and announced on the electronic portal in accordance with Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health concerning herbal medicine trading activities, they may continue operations until December 31, 2020. Before January 1, 2021, herbal medicine processing and traditional medicine production facilities must submit applications for issuance of a Business Registration Certificate for Pharmaceutical Operations within the scope of herbal processing and traditional medicine production in accordance with Article 5 of this Circular and comply with production conditions stipulated in Articles 13, 14, 15, 16, 17, 18, 19, and 20 of Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health concerning herbal medicine trading activities. The application process, evaluation procedures, and handling of evaluation results shall be carried out in accordance with Articles 5, 6, 7, and 8 of this Circular.

Article 20. Responsibility for Implementation

1. The Drug Administration Department shall be responsible for:

a) Take the lead and coordinate with relevant units to organize the dissemination and popularization of this Circular. Serve as the focal point to compile a list of GMP assessments suitable for each type of production based on transparency, clarity, and accuracy for evaluation, to be submitted to the Ministry of Health for issuance, serving as the basis for implementing GMP at pharmaceutical production and raw material manufacturing facilities and for the evaluation by drug regulatory authorities.

b) Implement this Circular for Provincial Health Departments, Sectoral Health Departments, and pharmaceutical production and raw material manufacturing facilities within their functional responsibilities.

c) Aggregate and publish on the Drug Administration's Electronic Information Portal the list of national production facilities that have been issued a Business Registration Certificate for Pharmaceutical Operations and/or a GMP certificate; update the status of the Business Registration Certificate for Pharmaceutical Operations and/or GMP certificate, GMP compliance status, and other information as stipulated in Clause 6, Article 8 of this Circular within their functional responsibilities.

d) Publish updated GMP documents on the Ministry of Health's Electronic Portal and the Drug Administration's Electronic Information Portal.

đ) Serve as the focal point or coordinate with the Ministry Inspectorate to conduct inspections and audits of GMP compliance adherence and handle violations within their authority.

2. The Traditional Medicine and Drug Administration Department shall be responsible for:

a) Implement this Circular for Provincial Health Departments, Sectoral Health Departments, and pharmaceutical production and raw material manufacturing facilities within their functional responsibilities.

b) Aggregate and publish on the Traditional Medicine and Pharmaceutical Administration's Electronic Information Portal the list of national production facilities that have been issued a Business Registration Certificate for Pharmaceutical Operations or a GMP certificate, updating the status of the Business Registration Certificate for Pharmaceutical Operations or GMP certificate, GMP compliance status, and other information as stipulated in Clause 6, Article 8 of this Circular within their functional responsibilities.

c) Serve as the focal point or coordinate with the Ministry Inspectorate 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 relevant units to organize the dissemination and popularization of this Circular and guide its implementation for units within their jurisdiction.

b) Participate in inspection, audit, and GMP compliance assessment teams; supervise and handle violations within their authority regarding compliance with pharmaceutical production and raw material manufacturing facilities within their jurisdiction.

4. The Central Institute of Pharmaceutical Inspection, Ho Chi Minh City Institute of Pharmaceutical Inspection, and National Institute of Vaccine and Biological Products are responsible for participating in GMP compliance assessment teams upon receipt of a written request.

5. Pharmaceutical production and raw material manufacturing facilities are responsible for:

a) Organizing the implementation of this Circular.

b) Ensuring continuous compliance with GMP principles and standards throughout the operation of the production facility.

c) Conducting production activities strictly within the scope approved and licensed in accordance with legal regulations.

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