Circular 30/2025/TT-BYT guiding the application of quality standards, testing of drugs and medicinal materials, and recall of and dealing with defective drugs

CIRCULAR

Guiding the application of quality standards, testing of drugs and medicinal materials, and recall of and dealing with defective drugs

Pursuant to the 2016 Law on Pharmacy;

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

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

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

At the proposal of the Director-General of the Drug Administration of Vietnam.

The Minister of Health hereby promulgates the Circular guiding the application of quality standards, testing of drugs and medicinal materials, and recall of and dealing with defective drugs.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular provides detailed guidance on the application of quality standards for drugs (including chemical drugs, herbal drugs, vaccines, biologicals) and medicinal materials (excluding herbal medicinal materials, traditional medicinal materials); the testing of drugs, medicinal materials, and primary packaging materials; and the procedures for recall of and dealing with defective drugs.

Article 2. Interpretation of terms

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

1. Drug and medicinal material quality standard means a document prescribing technical properties, including quality criteria, quality levels, test methods and other management requirements related to the quality of a drug or medicinal material.

2. Qualified drug means a drug that meets the quality standards registered with a competent state authority.

3. GLP stands for Good Laboratory Practices.

4. WHO stands for World Health Organization.

5. ICH stands for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Chapter II

APPLICATION OF DRUG AND MEDICINAL MATERIAL QUALITY STANDARDS

Article 3. General provisions

1. Pharmaceutical businesses and drug preparation establishments may choose to announce the application of quality standards for drugs and medicinal materials according to the Pharmacopoeia of Vietnam or apply in-house standards as prescribed at Point b, Clause 2, Article 102 of the Law on Pharmacy and in Article 4, Article 5 of this Circular.

2. Pharmaceutical businesses and drug preparation establishments shall validate and assess test methods stated in the quality standards applicable to drugs and medicinal materials as announced by their manufacturers. The validation of test methods must comply with the guidance on validation of analytical procedures/methods of the Association of South East Asian Nations or ICH as prescribed in the Circular on registration of drugs and medicinal materials promulgated by the Minister of Health.

3. The Ministry of Health shall appraise dossiers and approve drug and medicinal material quality standards in accordance with the regulations on registration of drugs and medicinal materials and the regulations on the grant of permits for import of drugs and medicinal materials without marketing authorizations.

Article 4. Application of pharmacopoeias

1. Application of the Pharmacopoeia of Vietnam and reference pharmacopoeias:

a) For pharmacochemical drugs, vaccines, and biologicals, pharmaceutical businesses and drug preparation establishments may apply the Pharmacopoeia of Vietnam or one of the following reference pharmacopoeias: the European Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia, International Pharmacopoeia, or Japanese Pharmacopoeia;

b) For herbal drugs, pharmaceutical businesses and drug preparation establishments may apply the pharmacopoeias prescribed at Point a of this Clause or the pharmacopoeia of the country of origin of such drug;

c) For drugs and medicinal materials that already have a monograph in at least one of the pharmacopoeias such as the Pharmacopoeia of Vietnam or a reference pharmacopoeia, pharmaceutical businesses and drug preparation establishments are encouraged to apply the pharmacopoeial standards prescribed at Point a of this Clause. The application of standards in the pharmacopoeias must cover all regulations on quality criteria, quality levels, and test methods prescribed in the corresponding drug or medicinal material monograph of the applied pharmacopoeia; and regulations on quality criteria, quality levels, and general test methods for the dosage form of the drug as prescribed in the corresponding Appendices of the pharmacopoeia;

d) In cases where a manufacturer announces the application of one of the pharmacopoeias prescribed at Point a of this Clause but uses a test method other than that prescribed in the specific monograph for the drug or medicinal material in the selected pharmacopoeia, the manufacturer must, in the dossier for the registration of the drug or medicinal material, prove the equivalence between its test method and the method stated in the pharmacopoeia. The test result obtained using the method stated in the pharmacopoeia shall serve as a basis for making a conclusion on the drug's quality.

In cases where the test method stated in the pharmacopoeia does not ensure the accuracy and precision of the test as required due to the effects of the formulation's ingredients or the preparation/manufacturing method, the drug manufacturer must provide an explanation and information in the dossier for the registration of the drug/the instructions for use. The test result obtained using the test method stated in the quality standard approved in the registration dossier shall serve as a basis for making a conclusion on the drug's quality.

2. For the application of foreign pharmacopoeias other than those prescribed at Point a, Clause 1 of this Article, the applied quality standards must at least meet the following requirements:

a) They must meet the requirements on quality criteria and quality levels prescribed in the corresponding quality standard monograph of the Pharmacopoeia of Vietnam or one of the current reference pharmacopoeias;

b) The applied general test method must conform to the corresponding general test method stated in the Pharmacopoeia of Vietnam or one of the reference pharmacopoeias prescribed at Point a, Clause 1 of this Article.

Article 5. Application of in-house standards formulated by manufacturers of drugs or medicinal materials, or drug preparation establishments

1. In-house standards for drugs and medicinal materials must comply with Point b, Clause 2, Article 102 of the Law on Pharmacy, specifically as follows:

a) They must meet the requirements on quality criteria and quality levels prescribed in the corresponding monograph of the Pharmacopoeia of Vietnam or a reference pharmacopoeia, and the quality criteria, quality levels, and general test methods prescribed in the Appendices of the Pharmacopoeia of Vietnam or a reference pharmacopoeia;

b) In cases where the Pharmacopoeia of Vietnam and reference pharmacopoeias prescribed at Point a, Clause 1, Article 4 of this Circular do not have a corresponding monograph for the drug or medicinal material, the establishment shall formulate the standard based on the outcomes of scientific research (including product research & development outcomes) or in accordance with the regulations of another foreign pharmacopoeia.

2. In-house standards for drugs prepared or formulated at medical examination and treatment establishments shall be formulated and subject to conformity assessment by such establishments, and are promulgated by the heads of the establishments.

Article 6. Updating of quality standards and application of updated pharmacopoeias

1. For drugs and medicinal materials for which a marketing authorization is sought: At the time a pharmaceutical business submits the registration dossier, the drug or medicinal material quality standard must comply with a pharmacopoeia in one of the following two cases:

a) The current version of the pharmacopoeia;

b) Versions of the pharmacopoeia preceding the current version, but not more than 02 years before the effective date of the current version.

2. For drugs and medicinal materials that have been granted marketing authorization:

a) Within a maximum period of 02 years from the effective date of the latest pharmacopoeia version, the marketing authorization holder and manufacturer are responsible for automatically updating and applying the drug or medicinal material quality standards in accordance with such pharmacopoeia version;

b) Within a maximum period of 02 years from the date of initial marketing authorization for a drug or medicinal material, the marketing authorization holder and manufacturer must update the quality standard to the current pharmacopoeia version if the quality standard in the registration dossier was based on a version preceding the current one;

c) In cases where the corresponding drug or medicinal material monograph in the pharmacopoeia changes in terms of quality criteria and quality levels towards being stricter and of higher quality, the marketing authorization holder must carry out the variation procedures as prescribed in the Circular on marketing authorization of drugs and medicinal materials.

3. In the course of marketing a drug or medicinal material, if the manufacturer or marketing authorization holder detects a factor that seriously affects the quality, safety, and efficacy of the drug, or upon request by the Ministry of Health (the Drug Administration of Vietnam), the manufacturer must update the drug or medicinal material quality standard with criteria to control such factor.

Chapter III

TESTING OF DRUGS AND MEDICINAL MATERIALS IN QUALITY MANAGEMENT

Article 7. General provisions

1. Application of quality standards in the testing of drugs and medicinal materials:

a) Testing must be conducted according to the approved and updated quality standards of the drug or medicinal material.

In cases where the quality standard of a drug or medicinal material has not been updated, the testing establishment shall apply the corresponding pharmacopoeia as prescribed in Clause 1 and Clause 2 of Article 6 of this Circular, based on the manufacture date of the tested batch of the drug or medicinal material.

The testing of drugs prepared or formulated at a medical examination and treatment establishment shall be conducted according to the drug quality standards formulated and promulgated by such establishment;

b) In cases where a drug or medicinal material is suspected of its origin or quality as prescribed at Points a, b, c, d, and dd, Clause 3, Article 18 of this Circular, or the test method stated in the drug or medicinal material quality standard is flawed, does not ensure accuracy and precision, or the qualitative test is non-specific, or a drug from medicinal materials is suspected of being adulterated with active pharmaceutical ingredients/chemical substances (the drug causes adverse reactions or has unusual effects), or there is information from foreign drug regulatory authorities that the drug or medicinal material contains impurities, the State-run drug testing establishment may apply analytical/testing methods prescribed in a pharmacopoeia or validated according to the guidance on analytical method validation prescribed in the Circular on marketing authorization of drugs and medicinal materials to test and issue a quality test result for the drug. The head of the drug testing establishment shall take accountability to the law for their test results.

2. The sampling of drugs and medicinal materials for testing must comply with Appendix I to this Circular, and the sampling record must be made using Form No. 01 provided in Appendix III to this Circular.

3. Notification of analysis and test results for drugs and medicinal materials:

a) The analysis or test result of a drug or medicinal material sample shall be presented in a test report or an analysis report made using Form No. 02 and Form No. 03 provided in Appendix III to this Circular;

b) A testing establishment shall notify the test or analysis result of a drug sample taken by a quality inspection agency within a maximum period of 15 days after receiving the sample in the following cases:

- The drug has information about serious adverse reactions;

- The drug belongs to an establishment that has committed a serious defect of Good Practices;

- The drug sample is additionally taken in the cases prescribed at Point b, Clause 1 and Point b, Clause 2, Article 14 of this Circular;

c) A testing establishment shall notify the test or analysis result within a maximum period of 20 days after receiving a drug sample in the following cases:

- The drug must be tested before marketing as prescribed in Clause 1, Article 8 of this Circular, except for vaccines and biologicals that are sera containing antibodies, derivatives of human blood and plasma as prescribed in Clause 2, Article 10 of this Circular.

- The drug does not fall into the cases prescribed at Point b and Point d of this Clause;

d) A testing establishment shall notify the test or analysis result of a sample within a maximum period of 30 days after receiving the drug or medicinal material sample in the following cases:

- The drug or medicinal material requires tests that have a long testing time;

- The drug or medicinal material has a quality standard that needs re-validation or re-assessment of the test results;

- There is a suspicion about the composition or quality of the drug or medicinal material, requiring the application of a test method other than that stated in the registered quality standard;

- The drug or medicinal material requires a test for which the testing establishment is not equipped (e.g., lack of equipment, machinery, chemicals, reagents, reference standards);

dd) For a drug sample for which the test method prescribed in the approved drug or medicinal material quality standard requires a period longer than 30 days (sterility test, biological assay, etc.), the maximum time limit for notifying the test result shall not exceed twice the time required to conduct the test;

e) In case of failing to meet the time limit for notification of analysis or test results as prescribed at Points b, c, d, and dd of this Clause, the testing establishment shall provide a written explanation enclosed with the test report or analysis report;

g) Within 24 hours from the time of issuing a test report or an analysis report, the testing establishment must send the test report or analysis report to the quality inspection agency, the manufacturer or importer whose drug or medicinal material was sampled, and the establishment where the sample was taken.

In cases where a drug or medicinal material sample fails to meet the quality standard, within 24 hours from the time of issuing the analysis report or test report, the testing establishment must send an official letter notifying the failure of the drug or medicinal material sample to meet the quality standard, enclosed with the test report or analysis report, to the provincial-level Department of Health of the locality where the drug or medicinal material was sampled and the Ministry of Health (the Drug Administration of Vietnam) in the form of an administrative document and an electronic document (scanned copy);

h) For a drug or medicinal material sample sent by a pharmaceutical business, an establishment using drugs, or an organization or individual for analysis, testing, or appraisal of its quality standard, the time limit for notification of the analysis or test result will be agreed upon by the parties.

4. Complaints and settlement of complaints about test results:

a) In case of disagreement with the sample test result, within 05 working days from the date of receiving the notification of the test result for the drug or medicinal material sample, the pharmaceutical business has the right to request the state quality inspection agency to designate another testing establishment to conduct analysis and testing to determine the quality test result of the drug or medicinal material;

b) The re-testing of a quality criterion with a complained test result shall be conducted at a testing establishment designated by the Ministry of Health as prescribed in Clause 2, Article 105 of the Law on Pharmacy.

5. Sample retention:

a) Drugs and medicinal materials must have their samples retained after being tested and a quality conclusion is made. Retained drug and medicinal material samples must be sealed and stored under the conditions indicated on their labels;

b) Sample retention period:

- For manufacturers and importers of drugs and medicinal materials: samples of finished drugs must be retained for at least 12 months after the drug's expiry date; samples of materials being active ingredients used for drug manufacture must be retained for at least 12 months after the expiry date of the finished products manufactured from those materials;

- For testing establishments for drugs and medicinal materials: the sample retention period lasts until the drug's expiry date, unless there is a dispute over the quality of the sample or a request for a longer retention period from a competent authority.

6. Retention of dossiers and documents:

a) Dossiers and documents related to the quality inspection of drugs and medicinal materials must be retained in accordance with the Law on Archives, the Decree guiding the Law on Archives, and the Ministry of Health’s Circular prescribing the retention periods for professional and operational dossiers and documents in the health sector;

b) Dossiers and documents, upon expiry of their retention period, shall be handled in accordance with the law regulations on archives.

Article 8. Pre-market testing for drugs prescribed in Clause 3, Article 103 of the Law on Pharmacy.

1. Drugs falling into one of the following cases must be tested by a testing establishment designated by the Ministry of Health (the Drug Administration of Vietnam) before being marketed:

a) Drugs prescribed at Point a and Point b, Clause 3, Article 103 of the Law on Pharmacy;

b) Biologicals that are derivatives of human blood and plasma;

c) Imported drugs as prescribed in Article 58 of the Government's Decree No. 163/2025/ND-CP dated June 29, 2025, detailing a number of articles of and providing measures for implementation of the Law on Pharmacy (hereinafter referred to as Decree No. 163/2025/ND-CP);

d) Drugs manufactured by foreign manufacturers on the list of foreign drug manufacturers with defective drugs of which 100% imported batches must be tested. In cases where a manufacturer commits a level-3 quality defect with respect to only 1 batch of a drug, testing is required only for the imported batches of such defective drug.

The list of foreign drug manufacturers with defective drugs of which 100% imported batches must be tested shall be published on the website of the Ministry of Health (the Drug Administration of Vietnam) as prescribed at Point b, Clause 6, Article 13 of this Circular.

2. Regulations on testing to determine the quality of drugs prescribed in Clause 1 of this Article:

a) Drug sampling:

- For drug samples prescribed at Points a, b, c, Clause 1 of this Article, the sampling shall be conducted by the manufacturer (for domestically manufactured drugs) or the importer (for imported drugs);

- For drugs prescribed at Point d, Clause 1 of this Article, the importer shall request a quality inspection agency or a State-run testing establishment to take drug samples. Within a maximum period of 05 working days, the quality inspection agency or State-run testing establishment shall take samples, seal them, and return them to the importer. The drug sampling must comply with Clause 2, Article 7 of this Circular;

b) The importer shall send the taken drug samples, enclosed with a photocopy of the manufacturer's original test report, to a drug testing establishment as prescribed in Clause 3 of this Article to test and determine the drug's quality according to the approved drug quality standard;

c) Manufacturers and importers of vaccines and biologicals that are sera containing antibodies, derivatives of human blood and plasma falling into the cases prescribed at Points a and Point b, Clause 1 of this Article shall send samples in accordance with Article 10 and Article 11 of this Circular;

d) Within the time limit prescribed in Clause 3, Article 7 of this Circular, the testing establishment must notify the test results for the received drug samples.

3. A testing establishment designated by the Ministry of Health (the Drug Administration of Vietnam) to test drugs prescribed in Clause 1 of this Article must be one of the following establishments:

a) A testing establishment prescribed in Clause 1, Article 35 of the Law on Pharmacy that meets GLP, including State-run testing establishments that meet GLP;

b) A drug and medicinal material testing service provider that has a Certificate of Eligibility for Pharmacy Business with the scope of drug testing;

c) A testing establishment that meets Good Laboratory Practice (GLP) principles of a Stringent Regulatory Authority (SRA) or a drug regulatory authority recognized by the Ministry of Health based on WHO classification, or is designated by one of these authorities to test drugs and medicinal materials for quality management purposes;

d) A national public testing establishment that has been assessed and announced by the WHO under the Prequalification of Quality Control Laboratories program.

4. The Ministry of Health (the Drug Administration of Vietnam) shall publish and update the list of designated testing establishments as prescribed in Clause 3 of this Article on the website of the Drug Administration of Vietnam.

5. On a monthly basis, the designated testing establishment shall report on drug testing to the Ministry of Health (the Drug Administration of Vietnam) using Form No. 07 provided in Appendix III to this Circular.

6. The drug manufacturer or importer shall be responsible for:

a) Paying the costs of testing to determine the quality of the manufacturer's or importer's drugs as prescribed;

b) Providing reference standards, reference substances, and impurity standards to the testing establishment in case the testing establishment has not yet developed them;

c) Only marketing and distributing drug batches that have test results meeting the quality standards;

d) Selecting a testing establishment that meets the requirements at Point a, Clause 3 of this Article to send samples for quality determination testing. In cases where the testing establishment is not equipped to test one or more quality criteria, it shall coordinate with the testing establishment to send the sealed samples to another testing establishment or a testing laboratory that meets the ISO/IEC 17025 standard and is equipped to test these criteria.

7. The testing of vaccines and biologicals that are sera containing antibodies, and biologicals that are derivatives of human blood and plasma shall be conducted in accordance with Article 10 and Article 11 of this Circular.

Article 9. Period during which testing is required for drugs from manufacturers on the list of foreign drug manufacturers with defective drugs of which 100% imported batches must be tested, updating of such period, and removal from this list

1. The period during which testing is required shall commence when the first batch is imported after the Ministry of Health (the Drug Administration of Vietnam) publishes the list of foreign drug manufacturers with defective drugs and is specified as follows:

a) 06 months for a manufacturer with no more than 02 drug batches with level-3 quality defects;

b) 12 months for a manufacturer with 01 drug batch with a level-2 quality defect or with 03 or more drug batches with level-3 quality defects;

c) 24 months for a manufacturer with 01 drug batch with a level-1 quality defect or with 02 or more drug batches with level-2 quality defects;

d) In cases where the manufacturer continues to have defective drugs, the required testing period shall be extended cumulatively.

2. A manufacturer shall be removed from the list of foreign drug manufacturers with defective drugs of which 100% imported batches must be tested upon fully meeting the following conditions:

a) The importer fully carries out the pre-market drug testing within the period prescribed in Clause 1 of this Article;

b) The manufacturer has no defective drugs (including voluntary recalls for quality reasons) during the period prescribed in Clause 1 of this Article.

3. Within 07 working days from the expiry of the period during which 100% imported batches of a drug from a foreign manufacturer must be tested, the Ministry of Health (the Drug Administration of Vietnam) shall review the results of dealing with such defective drug, reports from the testing establishment engaged in drug testing prescribed in Article 8 of this Circular, and reports from the manufacturer and drug marketing authorization holder (if any) to announce an update to the period for imported drugs or to remove the manufacturer that meets the conditions prescribed in Clause 2 of this Article from the list of foreign drug manufacturers with defective drugs of which 100% imported batches must be tested.

Article 10. Testing of vaccines and biologicals that are sera containing antibodies, derivatives of human blood and plasma before marketing

1. Manufacturers and importers must send samples and production dossiers of vaccines and biologicals that are sera containing antibodies, and biologicals that are derivatives of human blood and plasma (hereinafter referred to as vaccines and biologicals) to a vaccine testing establishment announced by the Ministry of Health (the Drug Administration of Vietnam) on the list of vaccine and biological testing establishments for pre-market testing and evaluation (hereinafter referred to as the vaccine and biological testing establishment). The dossier for sending samples for testing is prescribed in Article 11 of this Circular.

Manufacturers and importers are only allowed to market and use batches of vaccine or biological that is a serum containing antibodies, or a derivative of human blood and plasma after a batch release certificate issued by the vaccine and biological testing establishment confirms that the batch of vaccine or biological was manufactured, tested, stored, and meets the quality standards, ensuring safety and efficacy in accordance with the dossier for the registration of the drug.

2. Within a maximum period of 60 days from the date of receiving sufficient samples and dossier as prescribed in Article 11 of this Circular, the vaccine and biological testing establishment shall:

a) Review the summary protocol of production and quality control from the manufacturer for the batch of vaccine or biological; the batch release certificate (certificate of quality) issued by the competent authority of the country of origin or a Stringent Regulatory Authority (SRA) or a drug regulatory authority recognized by the Ministry of Health based on WHO classification for imported vaccines and biologicals (if any);

b) Conduct testing of the submitted vaccine and biological samples. The exemption or reduction of one, some, or all tests in the testing process of vaccine and biological samples shall be carried out in accordance with Article 12 of this Circular;

c) Issue a batch release certificate using Form No. 08 provided in Appendix III to this Circular, which concludes on the quality, safety, and efficacy of the batch of vaccine or biological;

d) Notify the test results to the Ministry of Health (the Drug Administration of Vietnam).

3. Based on Clause 4, Article 103 of the Law on Pharmacy and Article 12 of this Circular, the Ministry of Health shall issue guidelines on batch release testing for vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma, including the following details:

a) General policies on batch release testing, including policies on exemption or reduction of tests for vaccines and biologicals whose quality have been assured during marketing and use based on risk assessment results and product quality trend analysis during import, marketing, and use;

b) Required tests for quality certification, and the time for issuing the certificate of quality for each vaccine and biological product. The exemption of one, some, or all tests in the testing process at the designated drug testing establishment for vaccines and biologicals is prescribed in Article 12 of this Circular;

c) A template for the summary protocol of production and quality control for batches of each type of vaccine and biological.

d) The guidelines shall be reviewed and updated annually upon changes in the quality trends of vaccines and biologicals or when new vaccine and biological products are granted marketing authorization.

4. The Ministry of Health (the Drug Administration of Vietnam) shall designate a vaccine and biological testing establishment from the list of testing establishments prescribed in Clause 4, Article 10 of this Circular to test and evaluate the quality of vaccines and biologicals before marketing when such establishment meets the following requirements:

a) It is a State-run testing establishment that meets GLP principles for the scope of testing vaccines and medical biologicals;

b) It has been assessed and announced by the WHO as meeting the Prequalification of Quality Control Laboratories program or has been accepted within the framework of a National Regulatory Authority (NRA) or WHO-Listed Authority (WLA) assessment for the scope of vaccine and biological testing.

5. For imported vaccines and biologicals intended to meet urgent needs for national defense, security, disaster relief, and epidemic prevention and control, the designated vaccine and biological testing establishment shall review and issue a certificate of batch quality as follows:

a) Review the manufacturer's batch test report; the batch release certificate (certificate of quality) issued by a foreign competent authority (if any);

b) Review information on storage and transportation conditions (Datasheet for monitoring storage conditions during transportation);

c) Conduct analysis of some physical and sensory properties to determine the product's stability during transportation.

Article 11. Dossier and samples for testing to evaluate the quality, safety, and efficacy of vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma

1. For domestically manufactured vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma, the manufacturer shall send the production dossier and samples of the product batch (finished and semi-finished products) to the designated vaccine and biological testing establishment, which shall comprise of:

a) A sample submission form for testing;

b) Samples of the vaccine or biological for testing (the number of samples for each type of vaccine or biological shall comply with the Ministry of Health's Guidelines on batch release testing for vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma);

c) A summary protocol of production and quality control for the vaccine or biological batch (a copy bearing the manufacturer's true-copy mark);

d) The manufacturer's batch test report.

2. For imported vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma, the importer must send the production dossier and samples of the product batch to the designated vaccine and biological testing establishment, which shall comprise of:

a) A sample submission form for testing;

b) Samples of the vaccine or biological for testing (the number of samples for each type of vaccine or biological shall comply with the Ministry of Health's Guidelines on batch release testing for vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma);

c) A summary protocol of production and quality control for the imported vaccine or biological batch (a copy bearing a true-copy mark of the manufacturer or importer);

d) A batch release certificate (certificate of quality) from the competent authority of the exporting country and the manufacturer's batch test report for each imported vaccine or biological batch (a copy bearing the importer's true-copy seal);

dd) A datasheet for monitoring storage conditions (cold chain) during the transportation of the imported batch (bearing the importer's true-copy mark) from temperature recording devices and freeze indicator results (if any).

3. The manufacturer and importer shall be responsible for the legality of the documents they provide.

In cases where it is necessary to ensure the supply of medical vaccines and biologicals to meet urgent needs for national defense, security, disaster relief, and epidemic prevention and control, the importer is exempt from submitting the summary protocol of production and quality control of the batch as prescribed at Point c, Clause 2 of this Article and the batch release certificate (certificate of quality) from the competent authority of the exporting country as prescribed at Point d, Clause 2 of this Article (the manufacturer's batch test report and the datasheet for monitoring storage conditions during transportation are mandatory).

4. The summary protocol of production and quality control for a vaccine or biological batch shall be made according to the WHO's guidance in Form No. 09 provided in Appendix III to this Circular.

Article 12. Regulations on the exemption of one, some, or all tests of the pre-market testing process at a drug testing establishment for vaccines and biologicals.

1. The exemption of one, some, or all tests of the pre-market testing process at a vaccine and biological testing establishment shall not apply to the batch or batches of vaccines and biologicals being imported for the first time.

2. Imported vaccines and biologicals shall be exempt from testing in the following cases:

a) Vaccines and biologicals imported from a country with which Vietnam has signed a mutual recognition agreement on drug quality control laboratories and drug test results, and batch release of vaccines and biologicals;

b) Vaccines and biologicals (excluding injectable vaccines and biologicals) imported from a country where the drug regulatory authority of the exporting country is a Stringent Regulatory Authority (SRA) or is recognized by the Ministry of Health based on WHO classification, and have been issued a batch release certificate (certificate of quality) by one of the competent authorities of that country;

c) Vaccines and biologicals (excluding injectable vaccines and biologicals) that have been prequalified by the WHO, are supplied through a United Nations procurement program, and have a batch release certificate (certificate of quality) issued by a competent regulatory authority;

d) A batch of vaccine or biological that is imported multiple times (02 or more times) and has been tested and issued a batch release certificate (certificate of quality) at the first importation. The time between importations does not exceed 12 months.

3. Imported vaccines and biologicals shall be exempt from testing for one or some quality criteria (excluding tests for physical and sensory properties and specific safety criteria) in the following cases:

a) Injectable vaccines and biologicals imported from a country where the drug regulatory authority of the exporting country is a Stringent Regulatory Authority (SRA) or is recognized by the Ministry of Health based on WHO classification, and have been issued a batch release certificate (certificate of quality) by one of the competent authorities of that country;

b) Injectable vaccines and biologicals that have been prequalified by the WHO, are supplied through a United Nations procurement program, and have a batch release certificate (certificate of quality) issued by a competent regulatory authority;

c) Biologicals that are derivatives of human blood and plasma, and biologicals that are sera containing antibodies that have been issued a batch release certificate (certificate of quality) by a competent regulatory authority.

4. The exemption or reduction of one or some tests of the testing process at the vaccine and biological testing establishment for any other vaccine or biological (excluding medical vaccines and biologicals prescribed in Clause 2 and Clause 3 of this Article) shall be based on a summary of the test results of the vaccine or biological and an assessment of its quality trend.

5. The vaccine and biological testing establishment shall conduct additional testing of one, some, or all quality criteria in the following cases:

a) During the dossier review, a deviation from the trend is detected in the manufacturing, testing, or storage process;

b) The results of product quality inspection during marketing and use reveal that the product fails to meet quality standards due to manufacturing reasons.

Chapter IV

PROVISIONS ON RECALL OF DRUGS AND DEALING WITH DEFECTIVE DRUGS

Article 13. Procedures for compulsory recall of drugs

1. Receipt of information on defective drugs by the Ministry of Health (the Drug Administration of Vietnam)

a) Information assessing that a drug fails to ensure treatment efficacy or safety from the advisory council for drug marketing authorization or the advisory council for management of adverse events following immunization;

b) Information on a drug's failure to meet quality standards from a drug testing establishment;

c) Information on a defective drug detected by the Drug Administration of Vietnam or an inspection agency;

d) Notification of a defective drug from a foreign manufacturer, regulatory authority, or state agency in charge of drug quality inspection;

dd) Information on a defective drug (including counterfeit or unknown origin drugs) detected by the police, customs, or market surveillance agencies.

2. Receipt of information on defective drugs by provincial-level Departments of Health

a) Information on a drug's failure to meet quality standards from a drug testing establishment;

b) Information on a defective drug detected in the respective locality by the Drug Administration of Vietnam or an inspection agency.

c) Information on a defective drug (including counterfeit or unknown origin drugs) detected by the police, customs, or market surveillance agencies within the province or municipality.

3. Determination of the level of defect

a) Within 24 hours from the time of receiving information on a defective drug as prescribed at Points a, c, d, and dd, Clause 1 and Clause 2 of this Article, the Ministry of Health (the Drug Administration of Vietnam) and the provincial-level Department of Health shall determine the level of defect with respect to the drug and conclude on the recall of the defective drug based on an assessment of the risk to the user's health, even in the case of a complaint about the test results;

In cases where it is necessary to consult the advisory council for drug marketing authorization to determine the level of defect as prescribed in Section IV of Appendix II to this Circular, the time limit for determining the level of defect with respect to the drug must be within 7 working days;

b) The levels of defect are prescribed provided in Appendix II to this Circular;

c) For information on a defective drug as prescribed at Point b, Clause 1 of this Article, it shall be dealt with in accordance with Article 14 of this Circular.

4. Dealing with defective drugs in the locality by the provincial-level Department of Health:

a) Within 24 hours from the time of receiving information on a defective drug as prescribed in Clause 2 of this Article, the provincial-level Department of Health shall compare the level of defect with respect to the drug with those prescribed in Appendix II to this Circular and issue a written notice on dealing with and recalling the drug in the locality if it is level-2 or level-3 defect as prescribed in Article 14 of this Circular;

b) Inspect and supervise the recall and sampling of drugs for quality inspection in the locality.

5. Dealing with of defective drugs by the Ministry of Health (the Drug Administration of Vietnam):

a) Within no more than 24 hours from the time of concluding on the drug recall for any defect as prescribed in Clause 1, Article 65 of the Law on Pharmacy, the Ministry of Health (the Drug Administration of Vietnam) shall issue a drug recall decision;

b) A recall decision must include the following information (if any): drug name, marketing authorization number or import permit number, active ingredient name, strength or concentration, dosage form, batch number, expiry date, manufacturer, importer, level of recall, and the establishment responsible for the recall;

c) A drug recalled under a decision issued by the Ministry of Health (the Drug Administration of Vietnam) may be identified as a single batch, multiple batches, or all batches of one or more drugs.

6. Notification of a drug recall decision:

a) A drug recall decision of the Ministry of Health (the Drug Administration of Vietnam) shall be notified by post, fax, email, telephone, or mass media. The scope of notification of a recall decision must comply with Clause 3, Article 63 of the Law on Pharmacy;

b) Immediately after a recall decision is issued, the Ministry of Health (the Drug Administration of Vietnam) shall publish the recall decision on the web portal of the Ministry of Health or the website of the Drug Administration of Vietnam, and the national pharmacy database; and update and publish on the website of the Ministry of Health (the Drug Administration of Vietnam) the list of foreign drug manufacturers with defective drugs of which 100% imported batches must be tested (with information on the level of quality defect, number of defects, and the testing period for imported drugs from each manufacturer) for foreign drug manufacturers whose drugs are recalled for failing to meet quality standards.

The provincial-level Department of Health shall publish information on the drug recall decision on its website immediately after receiving the recall decision.

Domestic drug manufacturers and importers must notify information about the recalled drug to the establishments trading in or using drugs that have purchased the drug;

c) In case of recalling a drug with a level-1 defect, in addition to complying with Point b of this Clause, the recall decision must be announced by the Ministry of Health on Vietnam Television and the Voice of Vietnam.

7. Implementation of drug recall:

a) Establishments trading in or using drugs must stop supplying or using the drug; quarantine the remaining stock at their premises; make a list of establishments trading in or using drugs and individuals (if any) that have purchased the drug, contact and receive the returned drug; and return it to the drug supplier;

b) The manufacturer (for domestically manufactured drugs) or the importer in coordination with the import entrustee or the main drug distributor (for imported drugs) shall be responsible for recalling the defective drug. A drug recall record shall be made using Form No. 04 provided in Appendix III to this Circular.

In cases where an establishment that trades or supplies the drug fails to recall the drug or receive the returned drug, the establishments and individuals that purchased or used the drug shall report to the local provincial-level Department of Health for dealing with it as prescribed;

c) The drug recall must be completed within the time limit prescribed in Clause 3, Article 63 of the Law on Pharmacy.

8. Reporting on recall results, evaluation of recall effectiveness, and additional dealing:

a) Within 01 working day for a level-1 recall, 03 working days for a level-2 or level-3 recall from the date of completing the recall, the establishment responsible for the recall must report in writing the recall results to the Ministry of Health (the Drug Administration of Vietnam), the provincial-level Department of Health of the locality where the drug was recalled, and the provincial-level Department of Health of the locality where the establishment is located. The report shall include the following documents:

- A summary report on the recalled drug using Form No. 05 provided in Appendix III to this Circular;

- A list of establishments trading in or using drugs (including the establishments supplied directly from the establishment responsible for recalling the defective drug and the establishments supplied from drug wholesalers) with information on their addresses, phone numbers, emails (if any), the quantity of drugs supplied, and the quantity of drugs recalled;

- Delivery and receipt records, return invoices, or other evidence of the drug recall;

- A self-assessment report on the effectiveness of the recall;

- The results of the investigation and evaluation of the cause, and risk assessment for other batches of the defective drug and/or other drugs manufactured on the same production line.

b) The Ministry of Health (the Drug Administration of Vietnam) shall review the recall result report prescribed at Point a of this Clause, and evaluate or assign the provincial-level Department of Health to evaluate the recall effectiveness. In cases where the recall effectiveness is assessed as not being thorough, and the product is likely to continue to be marketed and used and poses a risk to the user's health, the Drug Administration of Vietnam shall coordinate with the provincial-level Department of Health and relevant functional agencies to organize a coerced recall.

Article 14. Dealing with of drugs failing to meet quality standards based on the sampling location

1. In cases where a defective drug sample is taken by a quality inspection agency at a drug retailer or a primary medical examination and treatment establishment (hereinafter collectively referred to as retailer):

a) Within 24 hours from the time of receiving the test report or analysis report from the testing establishment, the provincial-level Department of Health shall seal the defective drug at the establishment where the sample was taken;

b) Within 48 hours from the time of receiving the test report or analysis report, the provincial-level Department of Health shall issue a written request for the marketing authorization holder, manufacturer, or importer to be responsible for coordinating with the wholesale distributor to:

- Report the drug distribution situation to wholesalers and primary or higher-level medical examination and treatment establishments (quantity manufactured, imported; name, address of the establishment that purchased the drug, quantity purchased, and remaining stock at each establishment) to the Ministry of Health (the Drug Administration of Vietnam) and the local provincial-level Department of Health within a maximum period of 07 working days from the date on which the Ministry of Health (the Drug Administration of Vietnam) issues the request;

- Request and coordinate with the quality inspection agency to take additional samples at the manufacturer, for domestic drugs, or the importer, for foreign drugs, and at least 02 establishments trading in or using drugs as prescribed in Clause 4 of this Article; and report the implementation results to the Ministry of Health (the Drug Administration of Vietnam) and the provincial-level Department of Health within a maximum period of 15 days from the date on which the provincial-level Department of Health issues the request;

- Send the taken samples to a central-level testing establishment for quality inspection of the non-compliant criterion.

c) Based on the test results of the additionally taken drug samples, the Drug Administration of Vietnam shall handle the case in accordance with Clause 5 of this Article.

2. In cases where a defective drug sample is taken by a quality inspection agency at a wholesaler or a primary or higher-level medical examination and treatment establishment (hereinafter referred to as wholesaler):

a) Within 24 hours from the time of receiving the test report or analysis report from the testing establishment, the provincial-level Department of Health shall seal the defective drug at the establishment where the sample was taken;

b) Within 48 hours from the time of receiving the test report or analysis report, the provincial-level Department of Health shall determine the level of defect and conclude on the recall of the defective drug in accordance with Appendix II to this Circular, and issue a written notice:

- Announcing the drug recall in the province or municipality where the sample was taken and at the establishments trading or using the drug that were supplied by the wholesaler where the drug sample was taken, in accordance with Clause 3 and Clause 4, Article 12 of this Circular;

- Requesting the marketing authorization holder, manufacturer, or importer to be responsible for coordinating with the wholesale distributor to:

+ Report the drug distribution situation to the wholesalers (quantity manufactured, imported; name, address of the establishment that purchased the drug, quantity purchased, and remaining stock at each establishment) to the Ministry of Health (the Drug Administration of Vietnam) and the local provincial-level Department of Health within a maximum period of 07 working days from the date on which the provincial-level Department of Health issues the written notice;

+ Request and coordinate with the quality inspection agency to take at least 02 additional drug samples at the establishments trading in or using drugs as prescribed in Clause 4 of this Article; and report the implementation results to the Ministry of Health (the Drug Administration of Vietnam) within a maximum period of 15 days from the date on which the provincial-level Department of Health issues the written notice;

+ Send the taken samples to a central-level testing establishment for quality inspection of the non-compliant criterion.

c) Based on the test results of the additionally taken drug samples, the Drug Administration of Vietnam shall handle the case in accordance with Clause 5 of this Article.

3. In cases where a drug sample is taken by a quality inspection agency at a manufacturer, importer, drug storage service provider, or a drug sample reveals a quality defect attributable to the manufacturing process, or in case a drug batch has been sampled simultaneously at 02 wholesalers, the Ministry of Health (the Drug Administration of Vietnam) shall determine the level of defect and conclude on the recall of the defective drug in accordance with Appendix II to this Circular, and issue a drug recall decision in accordance with Clause 3, Article 12 of this Circular. The scope and time of recall shall comply with Clause 3, Article 63 of the Law on Pharmacy.

4. Requirements for additional sampling for quality inspection as prescribed in Clause 1 and Clause 2 of this Article:

The drug quality inspection agency shall determine the sampling plan based on the distribution report from the manufacturer or importer; priority shall be given to sampling in the following order:

a) Drug samples taken at wholesalers in different provinces and municipalities; including the wholesaler that supplied the drug to the establishment where the sample is taken and the quality defect was detected;

b) Drug samples taken at wholesalers in different provinces and municipalities;

c) Drug samples taken at wholesalers in the same province or municipality;

d) Drug samples taken at a wholesaler and a retailer;

dd) Drug samples taken at a retailer when the manufacturer or importer proves that the drug is no longer stored at wholesalers;

e) No additional samples shall be taken from the recalled drug quantity.

5. Processing of test results of additionally taken drug samples.

a) In cases where the additionally taken drug samples meet the quality standards, the Ministry of Health (the Drug Administration of Vietnam) shall issue a written document directing the provincial-level Department of Health to handle the drug at the retailer where the initial sample was taken in the case prescribed in Clause 1 of this Article, or at the wholesaler and the recalled drug in the province or municipality in the case prescribed in Clause 2 of this Article;

b) In cases where at least 01 additionally taken drug sample at a retailer fails to meet the quality standards, the Ministry of Health (the Drug Administration of Vietnam) shall assess the risk, issue a written notice determining the level of defect and the responsible establishment, direct the provincial-level Department of Health to deal with the drug at the retailers where the samples were taken, and issue a warning about the drug's storage conditions and quality;

c) In cases where at least one (01) additionally taken drug sample at a wholesaler or all additionally taken drug samples at retailers as prescribed at Point dd, Clause 4 of this Article fail to meet the quality standards, the Ministry of Health (the Drug Administration of Vietnam) shall determine the level of defect and conclude on the recall of the defective drug in accordance with Appendix II to this Circular, and issue a drug recall decision in accordance with Clause 3, Article 12 of this Circular;

d) In cases where the manufacturer or importer reports that there are no more samples being marketed or used, or the regulatory authority or quality inspection agency reports that no additional samples could be taken, or not enough samples were taken as required, but the samples that were taken meet the quality standards, the Ministry of Health (the Drug Administration of Vietnam) shall issue a warning to the provincial-level Department of Health and the testing system to review and take additional samples as prescribed. The manufacturer or importer must bear the cost of taking/purchasing samples and the sample testing fee.

Article 15. Procedures for voluntary recall of drugs

1. A pharmaceutical business (manufacturer or importer of drugs) shall conduct a voluntary recall in the following cases:

a) The pharmaceutical business self-detects and concludes that a drug is defective or shows signs of defect, and does not ensure the quality, safety, and therapeutic efficacy of the drug;

b) The pharmaceutical business recalls a drug for commercial reasons;

c) The pharmaceutical business takes its own samples, tests the quality, or sends samples for quality testing and issues a voluntary recall decision before the regulatory or drug quality inspection agency takes samples for drug quality inspection.

2. Cases not considered as voluntary recall:

a) A drug for which a sample has been taken by a regulatory or quality inspection agency for drug quality inspection and a quality defect has been concluded;

b) A drug with serious adverse reactions or a series of adverse reactions as reported by the National Drug Information and Adverse Drug Reaction Center;

c) A drug of which the safety and therapeutic efficacy are not ensured as concluded by the advisory council for drug marketing authorization.

3. A pharmaceutical business (manufacturer or importer of drugs) after detecting a drug that is defective or shows signs of quality defect shall:

a) Self-assess and determine the level of defect with respect to the drug as prescribed in Clause 2, Article 63 of the Law on Pharmacy;

b) Issue a recall decision for the recalled drug and send it to the distributors or users that have received the drug. The scope of the recall notification may cover one, several provinces, municipalities, or the whole country, based on risk assessment and the cause of the defect;

c) Report to the Ministry of Health (the Drug Administration of Vietnam) about the defective drug, including information related to the defect, the results of the self-assessment of the level of defect, and the level and scope of the recall;

d) Organize the recall and receive the recalled drug;

dd) Issue another recall decision superseding the previously issued one in cases where the Ministry of Health has an opinion that the level and scope of the recall are inappropriate and the safety and therapeutic efficacy are not ensured;

e) Report the results of the recall and the dealing with the recalled drug; the results of the investigation and evaluation to determine the cause and corrective measures to ensure the quality of manufactured or imported drugs.

The pharmaceutical business may only reprocess or re-export the recalled drug after reporting to and receiving an opinion from the Ministry of Health (the Drug Administration of Vietnam) as prescribed in Clause 3 and 4, Article 16 of this Circular.

4. The Ministry of Health (the Drug Administration of Vietnam), with respect to any voluntary drug recall, shall:

a) Review the report on the drug recall decision of the pharmaceutical business. In cases where the assessment of the recall level and scope is deemed inappropriate, to issue a written request for the pharmaceutical business to adjust the recall level and scope to ensure safety for drug users;

b) Provide an opinion on the proposal to reprocess or re-export the recalled drug;

c) Inspect the manufacturer's corrective actions in case of a level-1 defect or repeated defects as prescribed in the Circular on Good Manufacturing Practices for drugs and medicinal materials.

Article 16. Dealing with defective drugs

1. A defective drug may be corrected or re-exported in the following cases:

a) A drug with a level-3 defect that does not fall into the cases prescribed at Point dd and e, Clause 1, Article 17 of this Circular;

b) A drug in violation of regulations on labeling or the package insert;

c) A drug packaged in an outer container from different component drugs packaged in separate primary containers (a kit) where one or more component drugs fail to meet quality standards. Based on the level of defect of any component drug, such component drug may be reprocessed, re-exported, or destroyed as prescribed. Other components that meet quality standards may be reprocessed and repackaged appropriately.

2. Procedures for proposing the correction of a recalled drug

a) The establishment with the recalled drug that proposes the correction of such drug shall send a written proposal to the Ministry of Health (the Drug Administration of Vietnam) enclosed with the corrective process, a risk assessment of the drug's quality and stability, and a program for monitoring and supervising the drug's quality, safety, and efficacy during marketing;

b) Within a maximum period of 60 days from the date of receiving the establishment's written proposal, the Ministry of Health (the Drug Administration of Vietnam) must consider and provide a written response of approval or disapproval. In case of disapproval, the reason must be clearly stated;

c) In cases where it is necessary to supplement or clarify information related to the correction, within a maximum period of 60 days from the date of receiving the written proposal from the Ministry of Health (the Drug Administration of Vietnam), the establishment must submit supplementary documents and explanations. After this period, if the establishment fails to submit the supplementary documents and explanations, the proposal will no longer be valid.

3. Procedures for proposing the re-export of a recalled drug:

a) The establishment with the recalled or defective drug shall send a written proposal to the Ministry of Health (the Drug Administration of Vietnam) enclosed with a re-export plan stating the time and country of re-export;

b) Within a maximum period of 15 days from the date of receiving the establishment's written proposal, the Ministry of Health (the Drug Administration of Vietnam) shall provide a written response of approval or disapproval of the re-export; in case of disapproval, the reason must be clearly stated.

4. The correction or re-export of a recalled drug may only be carried out after obtaining written approval from the Ministry of Health (the Drug Administration of Vietnam).

Article 17. Destruction of drugs:

1. A drug must be destroyed in one of the following cases:

a) The drug has expired;

b) The drug was damaged during manufacturing, storage, or transportation;

c) The drug is a retained sample whose retention period has expired as prescribed;

d) The drug was recalled due to a level-1 or level-2 defect;

dd) The drug was recalled due to a level-3 defect, was reviewed by the Ministry of Health (the Drug Administration of Vietnam) as prescribed in Clause 3 and Clause 4, Article 15 of this Circular, and was concluded as being unable to be corrected or re-exported;

e) The drug was recalled due to a level-3 defect and was permitted by the Ministry of Health (the Drug Administration of Vietnam) to be corrected or re-exported, but the establishment failed to do so;

g) Counterfeit drugs, smuggled drugs, drugs of unknown origin, and drugs containing prohibited substances;

h) Drugs that must be destroyed as prescribed in the Decree on administrative penalties in the health sector.

i) Drugs manufactured from materials that do not meet quality standards, unless the non-compliant criterion is addressed during the manufacturing process and does not affect the manufacturing process and drug quality (e.g., moisture content, etc.).

2. Destruction of drugs at drug manufacturers, importers, wholesalers, drug testing establishments, hospitals, and institutes with patient beds:

a) The head of a drug manufacturer, importer, wholesaler, drug testing establishment, hospital, or institute with patient beds that has drugs to be destroyed shall issue a decision to establish a drug destruction council to organize the drug destruction, decide on the destruction method, and supervise the drug destruction. The council must be constituted by at least 03 members, including 01 representative who is the person in charge of professional matters of the establishment;

b) The destruction of drugs must ensure safety for people and animals and prevent environmental pollution in accordance with the law regulations on environmental protection;

c) The establishment with the drugs to be destroyed shall bear full responsibility related to the drug destruction. A report, enclosed with a drug destruction record, must be sent to the local provincial-level Department of Health in the cases of drug destruction prescribed at Points d, dd, e, g, and h, Clause 1 of this Article. The drug destruction record shall be made using Form No. 06 provided in Appendix III to this Circular.

3. Regulations on the destruction of vaccines:

a) At least 07 working days before destroying a vaccine, the establishment with the vaccine to be destroyed must send a written notice of the destruction plan to the local provincial-level Department of Health, which must include information on the name, quantity, strength or concentration of each vaccine to be destroyed, the reason for destruction, the time of destruction, the location of destruction, and the destruction method. The provincial-level Department of Health shall be responsible for supervising the vaccine destruction;

b) The vaccine destruction process and the destruction of vaccines must be carried out in strict accordance with the applicable regulations on medical waste management and hazardous waste management. The establishment with the vaccine to be destroyed shall send a written report on the vaccine destruction, enclosed with a destruction record, to the local provincial-level Department of Health and the Drug Administration of Vietnam. The vaccine destruction record shall be made using Form No. 06 provided in Appendix III to this Circular.

4. The destruction of drugs under special control must comply with Article 37 of Decree No. 163/2025/ND-CP.

5. Destruction of drugs at retailers and medical clinics:

a) The destruction of drugs shall be carried out under a contract with an industrial waste treatment establishment;

b) The person in charge of professional matters of a retailer or the head of a medical clinic shall be responsible for the drug destruction, supervise the drug destruction, and retain documents on the drug destruction.

6. The time limit for dealing with a recalled drug shall not exceed 12 months from the time of completing the recall as prescribed at Points a, b, and c, Clause 3, Article 63 of the Law on Pharmacy.

Article 18. Temporary suspension of trading, use, and sealing for preservation of drugs showing signs of being unsafe for users.

1. The Ministry of Health (the Drug Administration of Vietnam) shall receive information, enclosed with relevant dossiers and documents (if any), regarding drugs showing signs of being unsafe for users from:

Information, enclosed with relevant dossiers and documents (if any), regarding drugs showing signs of being unsafe for users from:

a) Functional agencies (including police, customs, market surveillance agencies, inspectorates, Vietnamese diplomatic missions abroad, foreign diplomatic missions in Vietnam);

b) The WHO, foreign drug regulatory authorities, or foreign health authorities;

c) The Departments of Health of municipalities and provinces;

d) The National Drug Information and Adverse Drug Reaction Center;

dd) Drug manufacturers, establishments trading and using drugs, and other agencies, organizations, and individuals.

2. Forms of information on drugs showing signs of being unsafe for users:

a) Official written documents from the agencies prescribed at Points a, c, and d, Clause 1 of this Article sent directly or by correspondence clerks to the Ministry of Health or through the Ministry of Health's electronic document management and administration system;

b) In addition to the forms prescribed at Point a of this Clause, official written documents from the agencies prescribed at Point b, Clause 1 of this Article may be sent via email or posted on the official web portals or websites of such agencies;

c) Complaints, denunciations, or direct presentations at competent authorities in accordance with the law regulations on complaints and denunciations from the agencies, organizations, and individuals prescribed at Point dd, Clause 1 of this Article.

3. Drugs showing signs of being unsafe for users include:

a) Drugs with reports of serious or repeated adverse reactions related to such drugs, which are not known adverse reactions of such drugs;

b) Drugs suspected of containing toxic substances or impurities exceeding the safe limit for users;

c) Drugs suspected of not meeting quality standards;

d) Drugs suspected of being counterfeit or of incorrect origin;

dd) Drugs manufactured from materials of unknown origin or that do not meet quality standards;

e) Drugs manufactured at a domestic manufacturer committing serious violations regarding drug manufacturing conditions, according to information from functional agencies (inspectorate, police, market surveillance agencies) or reports from provincial-level Departments of Health;

g) Drugs manufactured at a foreign manufacturer with serious violations of the principles and standards of Good Manufacturing Practices for drugs and medicinal materials, and at the same time, one or more drugs manufactured by the establishment are recalled or have their marketing and use suspended due to defects, according to notifications from foreign drug regulatory authorities or foreign health authorities.

4. Responsibilities of the Ministry of Health (the Drug Administration of Vietnam) in processing information, notifying the temporary suspension of trading, use, and sealing for preservation of drugs showing signs of being unsafe for users:

a) Within no more than 07 working days from receiving information as prescribed in Clause 1 and Clause 2 of this Article, the Ministry of Health (the Drug Administration of Vietnam) shall review the received information, and coordinate with at least one of the professional agencies and organizations (the advisory council for issuance of drug and medicinal material marketing authorization; the advisory council for vaccine use; the National Institute of Drug Quality Control; the Ho Chi Minh City Institute of Drug Quality Control; the National Institute for Control of Vaccines and Biologicals; the drug and therapeutics council of a special-grade hospital) or with inspectorates, police, customs, and market surveillance agencies, if necessary, to assess the risk to the user's health and determine the scope of the temporary suspension of trading and use of drugs showing signs of being unsafe for users as prescribed in Clause 3 of this Article;

b) Within no more than 03 working days from the date of concluding that a drug poses a risk to the user's health, the Ministry of Health (the Drug Administration of Vietnam) shall issue a written notice of the temporary suspension of manufacturing, importing, distributing, using, and sealing of one or more batches of drugs or drug products showing signs of not ensuring safety for users;

c) The period for temporary suspension of trading, use, and sealing for preservation of drugs showing signs of being unsafe for users for verification purposes is prescribed as follows:

The temporary suspension period shall not exceed 02 months from the date on which the written notice is issued. In complex cases or due to insufficient domestic technical conditions for drug analysis and testing, the suspension period may be extended by no more than 02 months.

In cases where, after the above-mentioned period, the police, market surveillance, or customs agency, or inspectorate issues a written request to continue the temporary suspension of trading and use to serve the investigation and verification process, the suspension period shall be extended based on the applicable regulations and at the request of the aforementioned functional agencies;

d) Within 03 working days from the date of concluding that the drug is not in defect or after the expiry of the temporary suspension notice as prescribed at Point c of this Clause without a conclusion of defect, the Ministry of Health (the Drug Administration of Vietnam) shall issue a written notice allowing the establishment to continue manufacturing, importing, distributing, and using the drug or drug batches that meet quality standards and are not expired.

In cases where it is concluded that the drug is defective and is unsafe for users, the Ministry of Health (the Drug Administration of Vietnam) shall issue a written notice to recall the drug that was temporarily suspended from distribution and use, and to stop the manufacturing and importation of the drug that is unsafe for users; impose administrative penalties or transfer the case to functional agencies for criminal liability examination as prescribed.

5. Responsibilities of the provincial-level Department of Health in processing information and notifying the temporary suspension of trading, use, and sealing for preservation of drugs showing signs of being unsafe for users:

a) A provincial-level Department of Health is responsible for disseminating the Ministry of Health's conclusion notice to establishments trading in or using drugs in the locality and supervising the temporary suspension of trading, use, and sealing for preservation of drugs showing signs of being unsafe for users;

b) Disseminating the conclusion notice of the Ministry of Health (the Drug Administration of Vietnam) allowing the establishments to continue trading or using the drug, or to recall the drug; supervising the implementation of the recall by the establishments trading in or using drugs as prescribed;

c) Coordinating with functional agencies in the locality to conduct inspections, checks, and verification of information related to drugs showing signs of being unsafe in the aforementioned cases that occur in the locality or at the request of the Ministry of Health; reporting the results to the Ministry of Health (the Drug Administration of Vietnam).

6. Pharmaceutical businesses and establishments that use the drugs shall:

a) Report fully and promptly to the Ministry of Health (the Drug Administration of Vietnam) or the provincial-level Departments of Health on cases of drugs showing signs of being unsafe for users;

b) Implement the temporary suspension of trading, use, and sealing for preservation of drugs showing signs of being unsafe for users according to the conclusion notice of the Ministry of Health (the Drug Administration of Vietnam); self-seal and preserve the drugs in accordance with the storage conditions stated on their labels;

c) Coordinate with functional agencies in the process of verifying drugs showing signs of being unsafe for users (providing dossiers, documents, and evidence to serve the verification process);

d) Continue the trading and use of the drug according to the Ministry of Health's (the Drug Administration of Vietnam) notice concluding that the drug complies with the regulations, or to carry out the recall of the drug that is unsafe for users according to the Ministry of Health's (the Drug Administration of Vietnam) drug recall notice in cases where the drug must be recalled as prescribed.

7. Specific regulations on the coordination between the Ministry of Health (the Drug Administration of Vietnam) and relevant functional agencies, organizations, and individuals in verifying and concluding on the drug's quality and the level of safety for drug users:

a) In cases of drug information prescribed in Clause 3 of this Article (unless otherwise prescribed at Points d, dd, and e), the Ministry of Health (the Drug Administration of Vietnam) shall report to the advisory council for drug marketing authorization or the advisory council for vaccine use (for vaccines) for consideration and conclusion;

b) In cases of drug information prescribed at Point c and Point dd, Clause 3 of this Article, the Ministry of Health (the Drug Administration of Vietnam) shall direct and coordinate with the National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, and the National Institute for Control of Vaccines and Biologicals to conduct analysis, testing, and conclude on the quality of the drug and medicinal material;

c) In cases of drug information showing signs of being counterfeit, drugs and medicinal materials of incorrect or unknown origin as prescribed at Point d and Point dd, Clause 3 of this Article, the Ministry of Health (the Drug Administration of Vietnam) shall issue a written notice transferring the information to the competent functional agency (the police/market surveillance/customs agency or the inspectorate) enclosed with dossiers and documents for investigation and verification according to their functions, competence, and the law regulations;

d) In cases of drug information prescribed at Point e, Clause 3 of this Article, the Ministry of Health (the Drug Administration of Vietnam) shall organize an ad-hoc inspection or check of the manufacturer regarding the maintenance of drug manufacturing conditions as prescribed for domestic pharmaceutical businesses and manufacturers;

dd) In cases of drug information prescribed at Point g, Clause 3 of this Article, the Drug Administration of Vietnam shall contact and exchange information with the drug regulatory authority or health authority of the country of origin, the drug regulatory authority that issued the defect notice, and conduct a Good Manufacturing Practice compliance assessment at the establishment if conditions permit;

e) In cases where it is necessary to have sufficient grounds for a conclusion, the central-level State-run drug testing establishment shall be the focal point for conducting analysis and testing to determine the drug's quality. The testing of some or all quality criteria according to the drug quality standard shall be determined by the Ministry of Health (the Drug Administration of Vietnam) in coordination with the professional agencies and organizations prescribed at Point a, Clause 4 of this Article, based on a risk assessment and the relationship with the signs of being unsafe for users, information on the drug's quality, usage situation, and information on monitoring adverse reactions and side effects of the drug.

Article 19. Responsibilities for recall drugs

1. Pharmaceutical businesses, medical examination and treatment establishments, and drug users shall:

a) Comply with Clauses 1, 2, and 3, Article 64 of the Law on Pharmacy;

b) Regularly check and update information on drug recalls on the Ministry of Health's web portal, the websites of the Drug Administration of Vietnam and the provincial-level Departments of Health.

2. The Drug Administration of Vietnam shall:

a) Receive information, determine the level of defect with respect to any drug, and issue a drug recall decision;

b) Notify the drug recall decision as prescribed at Point a, Clause 4, Article 12 of this Circular, and publish information about the recalled drug on the Ministry of Health's web portal and the Drug Administration of Vietnam's website after the drug recall decision is issued. Coordinate with Vietnam Television and the Voice of Vietnam to publish information on recalls of drugs with level-1 defects;

c) Review reports from drug manufacturers and importers on voluntary drug recalls; to issue a request for the establishment to adjust the recall level and scope when the assessment of the voluntary recall level and scope does not ensure safety for users. Supervise the voluntary recalls by the establishments.

d) Review and provide opinions on the proposals to reprocess/re-export the recalled drugs from the pharmaceutical businesses.

dd) Coordinate with relevant units (inspectorates, provincial-level Departments of Health, sectoral health authorities) to inspect and check the organization and implementation of drug recalls; to handle establishments with defects in accordance with the law regulations;

e) Issue written detailed guidelines on the process of dealing with and recalling drugs, and evaluating the effectiveness of the implementation of drug recall notices by pharmaceutical manufacturers and businesses.

3. Provincial-level Departments of Health shall:

A provincial-level Department of Health has responsibilities as prescribed in the Law on Pharmacy and shall:

a) Issue a decision to recall a drug in the locality in case of a level-2 or level-3 defect. Publish information on the decisions on drug recall/temporary suspension of drug distribution and use on their websites;

b) Organize the notification and dissemination to drug manufacturers, establishments trading in drugs, medical examination and treatment establishments in their respective localities about information on drug recalls/temporary suspension of drug distribution and use;

c) Carry out or direct the testing centers to coordinate with the establishments with the defective drugs to take additional drug samples as prescribed at Point b, Clause 1 or Point b, Clause 2, Article 14 of this Circular;

d) Organize the supervision of drug recalls in their respective localities; handle and impose penalties on establishments that violate regulations on drug recalls within their competence; report the results of handling and imposition of penalties to the Ministry of Health (the Drug Administration of Vietnam);

dd) Engage in or carry out the evaluation of the effectiveness of drug recalls by pharmaceutical businesses in their respective localities under the direction of the Ministry of Health (the Drug Administration of Vietnam). Report to the Ministry of Health (the Drug Administration of Vietnam) on cases where manufacturers, importers, or wholesalers that are the main drug distributors fail to carry out or inadequately carry out the drug recalls;

e) Organize and engage in the coerced recalls of drugs.

Chapter V

IMPLEMENTATION PROVISIONS

Article 20. Transitional provisions

From the effective date of this Circular, dossiers related to drug and medicinal material quality standards, and the recall of and dealing with defective drugs that were received before the effective date of this Circular but are still being processed shall be subject to the relevant regulations of this Circular or the regulations in effect before the effective date of this Circular, in a manner that is convenient for businesses, organizations, and individuals.

Article 21. Effect

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

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

a) Circular No. 11/2018/TT-BYT dated May 04, 2018, of the Minister of Health, on the quality of drugs and medicinal materials;

b) Circular No. 03/2020/TT-BYT dated January 22, 2020, of the Minister of Health, amending and supplementing a number of articles of Circular No. 11/2018/TT-BYT dated May 04, 2018, of the Minister of Health, on the quality of drugs and medicinal materials;

c) Circular No. 45/2024/TT-BYT dated December 24, 2024, of the Minister of Health, amending and supplementing a number of articles and appendices to Circular No. 11/2018/TT-BYT dated May 04, 2018, of the Minister of Health, on the quality of drugs and medicinal materials;

d) Clause 2, Article 1 of Circular No. 23/2021/TT-BYT dated December 09, 2021, of the Minister of Health, amending and supplementing a number of legal documents issued by the Minister of Health.

Article 22. Organization of implementation

1. The Drug Administration of Vietnam is responsible for:

a) Assuming the prime responsibility for, and coordinating with relevant units in, the dissemination, popularization, and implementation of this Circular;

b) Assuming the prime responsibility for, and coordinating with the National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, and the National Institute for Control of Vaccines and Biologicals in, developing drug sampling plans for quality inspection at manufacturers, drug preparation establishments, importers, exporters, storage establishments, wholesalers, retailers, and establishment using drugs nationwide, and submit them to the Ministry of Health for consideration, approval, and budget allocation for implementation within its competence.

Carrying out the drug sampling for quality inspection according to the approved plans and updating the Ministry of Health's drug quality inspection database with information on the taken drug and medicinal material samples (including information: name of each drug or medicinal material, strength, concentration, dosage form, batch number, expiry date, marketing authorization number or import permit number, manufacturer, importer, establishment where the sample is taken) and the quality inspection results of the drug and medicinal material samples;

c) Providing scientific and technical information related to ensuring the quality of drugs and medicinal materials.

Providing the National Institute of Drug Quality Control and the Ho Chi Minh City Institute of Drug Quality Control with label samples and the quality standards of drugs and medicinal materials that have been granted marketing authorizations or import permits, and their updated versions in case of changes. For vaccines and biologicals, the label samples and quality standards shall be sent to the National Institute for Control of Vaccines and Biologicals.

Organizing the review, appraisal, and submission to the Ministry of Health for promulgation of the Ministry of Health's guidelines on batch release testing for vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma;

d) Organizing the quality inspection of drugs and medicinal materials manufactured, prepared, marketed, and used nationwide. Directing and supervising the drug testing system nationwide. Concluding on the quality of drugs based on the drug test results of the State-run drug testing establishments and relevant dossiers;

dd) Assuming the prime responsibility for and coordinating the performance of state inspection, examination, and handling of violations of the law regulations on drug quality within its competence;

e) Assuming the prime responsibility for, and coordinating with relevant functional agencies in, translating, publishing, and updating on the Drug Administration of Vietnam's website the World Health Organization's (WHO) guidance documents on drug destruction for establishments to refer to in the process of selecting a destruction method and carrying it out.

2. Provincial-level Departments of Health is responsible for:

a) Organizing the implementation of drug quality inspection in their respective localities and dealing with defects in accordance with the law regulations;

b) Developing plans for sampling drugs and medicinal materials for quality inspection at manufacturers, drug preparation establishments, importers, exporters, storage establishments, wholesalers, retailers, and establishment using drugs in the provinces and municipalities, and submitting them to the respective provincial-level People's Committees for consideration, approval, and budget allocation for implementation within their competence;

c) Updating the Ministry of Health's drug quality inspection database with information on the taken drug and medicinal material samples (including information: name of each drug or medicinal material, strength, concentration, dosage form, batch number, expiry date, marketing authorization number or import permit number, manufacturer, importer, establishment where the sample is taken) and the quality inspection results of the drug and medicinal material samples.

3. Central-level drug testing establishments (the National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, the National Institute for Control of Vaccines and Biologicals) are responsible for:

a) Conducting analysis and testing of samples to determine the quality of drugs and medicinal materials manufactured, marketed, and used; reporting the test results to the Ministry of Health (the Drug Administration of Vietnam) and the provincial-level Departments of Health of the localities where the samples were taken;

b) Researching, establishing, and publishing on the websites of the Institutes and the Drug Administration of Vietnam a list of reference standards, reference substances, and impurity standards for the analysis and testing of drug and medicinal material samples manufactured, imported, marketed, and used in the territory of Vietnam;

c) The National Institute of Drug Quality Control and the Ho Chi Minh City Institute of Drug Quality Control are responsible for providing provincial-level drug testing centers, within their respective assigned areas, with copies or electronic versions of the quality standards of drugs and medicinal materials;

d) The National Institute for Control of Vaccines and Biologicals shall act the focal point, on an annual basis, for reviewing and assessing the quality trend of vaccines and biologicals, and drafting the Ministry of Health's Guidelines on batch release testing for vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma; and submitting them to the Drug Administration of Vietnam for review and to the Ministry of Health for promulgation. Updating information on the issuance of batch release certificates for vaccines and biologicals that are sera containing antibodies, and derivatives of human blood and plasma on the websites of the Institute and the Drug Administration of Vietnam.

Other designated vaccine and biological testing establishments are responsible for providing reports on the results of batch release testing for vaccines and biologicals to the focal-point Institute and the Ministry of Health (the Drug Administration of Vietnam).

4. Testing centers shall provinces and municipalities are responsible for:

a) Conducting analysis and testing of samples to determine the quality of drugs and medicinal materials manufactured, marketed, and used;

b) Reporting the test results to the provincial-level Departments of Health and the Ministry of Health (the Drug Administration of Vietnam).

5. Establishments trading in drugs are responsible for:

a) Organizing the research and implementation of the law regulations on the quality of drugs and medicinal materials promulgated under this Circular;

b) Implementing the regulations on the inspection and control of the origin and quality of drugs and medicinal materials. Carrying out quality management activities to ensure the quality of drugs and medicinal materials throughout their operations;

c) Establishing a system of dossiers and documents to ensure the traceability of the marketing process of drugs and medicinal materials. Monitoring and supervising the quality of drugs and medicinal materials traded by them; promptly detecting and dealing with defective drugs, and reporting them to the regulatory authorities and the drug quality inspection agencies;

d) Abiding by the sampling for inspection by the quality management agency, and issuing payment invoices for the samples taken for inspection in accordance with regulations;

dd) Providing reference standards, placebo samples, solvents, and chemicals for the analysis and testing activities to determine the quality of drugs in cases where they are not readily available on the market.

6. Pending the appointment of drug quality controllers at all levels, the Ministry of Health shall assign:

a) The National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, the National Institute for Control of Vaccines and Biologicals, according to their assigned functions, tasks, and scope of operation:

- To develop plans for sampling drugs for quality inspection and supervision of drugs and medicinal materials; to estimate, receive, and use the annual budget for drug and medicinal material sampling and testing activities;

- To carry out the sampling of drugs and medicinal materials according to the approved plans at pharmaceutical businesses and establishments using drugs;

- To update information on the drug and medicinal material samples taken for quality inspection and the test results of the drug and medicinal material samples into the Ministry of Health's drug quality inspection database;

- To report the test results to the Ministry of Health (the Drug Administration of Vietnam) and the provincial-level Department of Health of the locality where the samples were taken for drug and medicinal material samples that do not meet quality standards as prescribed in Clause 3, Article 7 of this Circular;

- The National Institute of Drug Quality Control to build the Ministry of Health's drug quality inspection database;

- To collect the sampling fees reimbursed by the establishments trading in drugs and the testing cost for drug and medicinal material samples that do not meet quality standards in accordance with the law regulations.

b) Testing centers shall provinces and municipalities:

- To develop sampling plans for quality inspection and supervision of drugs and medicinal materials; to estimate, receive, and use the annual budget for drug and medicinal material sampling and testing activities;

- To carry out the sampling of drugs and medicinal materials for quality inspection according to the approved plans at the establishments trading in or using drugs;

- To update information on the drug and medicinal material samples taken for quality inspection and the test results into the Ministry of Health's drug quality inspection database;

- To report the test results to the Ministry of Health (the Drug Administration of Vietnam) and the provincial-level Departments of Health for drug and medicinal material samples that do not meet quality standards as prescribed in Clause 3, Article 7 of this Circular;

- To collect the sampling fees reimbursed by the establishments trading in drugs and the testing cost for drug and medicinal material samples that do not meet quality standards in accordance with the law regulations.

Article 23. Responsibilities for implementation

The Director of the Drug Administration of Vietnam, the Chief of the Ministry’s Office, heads of units under and affiliated with the Ministry of Health, Directors of provincial-level Departments of Health, pharmaceutical businesses, and other relevant agencies, organizations, and individuals shall be responsible for implementing this Circular.

Any problems arising in the course of implementation should be reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and resolution.