Circular 03/2020/TT-BYT amending Circular 11/2018/TT-BYT on quality of drugs

CIRCULAR

Amending and supplementing a number of articles of the Minister of Health’s Circular No. 11/2018/TT-BYT of May 4, 2018, providing quality of drugs and drug materials^[1]

Pursuant to April 6, 2016 Law No. 105/2016/QH13 on Pharmacy;

Pursuant to the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy;

Pursuant to the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of provisions related to business investment conditions under the state management of the Ministry of Health;

Pursuant to the Government’s Decree No. 75/2017/ND-CP of June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director General of the Drug Administration of Vietnam,

The Minister of Health promulgates the Circular amending and supplementing a number of articles of the Minister of Health’s Circular No. 11/2018/TT-BYT of May 4, 2018, providing quality of drugs and drug materials.

Article 1.To amend and supplement a number of articles of the Minister of Health’s Circular No. 11/2018/TT-BYT of May 4, 2018, providing quality of drugs and drug materials

1. To amend Article 1 as follows:

“Article 1. This Circular prescribes the application of standards on quality of drugs (pharmacochemical drugs, drugs from medicinal materials, vaccines and biologicals) and drug materials (including also drug materials and medicinal materials in the form of semi-finished products, except medicinal materials); testing of drugs and drug materials, and procedures for recall and disposal of violating drugs.”

2. To amend and supplement Clause 1 of Article 7 as follows:

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

a/ The testing of a drug or drug material shall be conducted based on the approved and updated quality standard applicable to such drug or drug material.

In case the quality standard applicable to a drug or drug material has not yet been updated, testing establishments shall apply a corresponding pharmacopoeia prescribed in Clause 1 or 2, Article 6 of this Circular, based on the manufacture date of the to-be-tested drug or drug material batch.

The testing of drugs prepared and processed at medical examination and treatment establishments must comply with quality standards formulated and announced by such establishments.

b/ In case the testing method stated in the quality standards of drugs or drug materials contains errors or fails to guarantee correctness or accuracy or in case of nonspecific qualitative testing or in case there is a doubt that drugs from medicinal materials are added with pharmaceutical substances/chemicals (drugs with side effects, drugs with unusual effects) or information provided by foreign drug administration authorities stating that drugs and drug materials contain impurities, state-run drug testing establishments may apply the analytical/testing methods that have been specified in the pharmacopoeia or appraised in accordance with the guidance on appraisal of analytical methods specified in Appendix I to the Minister of Health’s Circular No. 32/2018/TT-BYT of November 12, 2018, on registration for marketing authorization of drugs and drug materials, for testing drugs and providing drug quality testing results. Heads of drug testing establishments shall take responsibility before law for drug testing results of their establishments.”

3. To amend and supplement Point c, Clause 3 of Article 7 as follows:

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

- The drug is tested before being marketed under Clause 1, Article 8 of this Circular, except vaccines and biologicals being sera containing antigens or human blood or plasma derivatives specified in Clause 2, Article 10 of this Circular.

- The drug falls beyond the cases specified at Points b and d of this Clause.”

4. To amend Clause 6 of Article 7 as follows:

“6. Retention of dossiers and documents:

a/ Dossiers and documents relating to quality inspection of drugs and drug materials shall be retained in accordance with the Law on Archives, the Decree guiding the Law on Archives and the Minister of Health’s Circular No. 53/2017/TT-BYT of December 29, 2017, prescribing the retention periods for specialized and professional dossiers and documents in the health sector.

b/ When their retention periods expire, dossiers and documents shall be disposed of in accordance with the law on archives.”

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

“3. The Ministry of Health (the Drug Administration of Vietnam) shall designate testing establishments satisfying Good Laboratory Practices (GLP) standards to conduct the drug testing specified in Clause 1 of this Article, including:

a/ GLP standard-satisfying testing establishments specified in Clause 1, Article 35 of the Law on Pharmacy, including also state-run drug testing establishments satisfying GLP standards;

b/ Establishments providing drug and drug material testing services possessing certificates of eligibility for pharmaceutical business within the scope of drug testing;

c/ GLP standard-satisfying testing establishments which are under stringent regulatory authorities (SRA) or are designated by these authorities to conduct drug and drug material testing for the purpose of drug quality management;

d/ National-level public testing establishments evaluated and announced by the World Health Organization (WHO) under the Quality Control Laboratory Prequalification Program.

In case a designated testing establishment is unqualified for conducting one or several test(s), it shall make an announcement thereof, seal samples for such test(s) and coordinate with drug manufacturers and importers in sending these samples to another testing establishment satisfying GLP standards, or a laboratory satisfying ISO/IEC 17025 standard and qualified for conducting such test(s).”

6. To add the following Point d to Clause 6 of Article 8:

“d/ To select a testing establishment satisfying the provisions specified at Point a, Clause 3 of this Article to send testing samples for drug quality determination. In case the testing establishment is unqualified for testing one or several quality criterion/criteria, to coordinate with the testing establishment in sending samples already sealed by the testing establishment to another testing establishment qualified for testing such criterion/criteria.”

7. To amend the title of Clause 2 of Article 10 as follows:

“Within 60 days after receiving sufficient samples and a complete dossier specified in Article 11 of this Circular, the National Institute for Control of Vaccines and Biologicals shall:”

8. To amend and supplement Point b, Clause 1 of Article 11 as follows:

“b/ Samples of the concerned vaccine or biological for testing (the number of samples for each type of vaccine or biological must comply with the Ministry of Health’s guidance on ex-works testing of vaccines and biologicals being sera containing antigens or human blood and plasma derivatives);”

9. To amend and supplement Point b, Clause 2 of Article 11 as follows:

“b/ Samples of the concerned vaccine or biological for testing (the number of samples for each type of vaccine or biological must comply with the Ministry of Health’s guidance on ex-works testing of vaccines and biologicals being sera containing antigens or human blood and plasma derivatives);”

10. To add the following Clause 4 to Article 11:

“4. A summary file on the manufacture and quality inspection of the vaccine or biological batch must comply with the WHO’s guidance provided in Form No. 9 of Appendix III to this Circular.”

11. To amend and supplement Article 14 as follows:

“Article 14. Disposal of drugs not up to quality standards based on places of sampling

1. In case samples of a violating drug are taken by a quality inspection agency at a drug retail establishment or level-3 or -4 medical examination and treatment establishment (below collectively referred to as retail establishment):

a/ Within 24 hours after receiving a test report or an analysis report from a testing establishment, the concerned provincial-level Department of Health shall seal the drug at the establishment where samples are taken;

b/ Within 48 hours after receiving a test report or an analysis report from a testing establishment, the Ministry of Health (the Drug Administration of Vietnam) shall request in writing the drug registrar, manufacturer or importer to coordinate with wholesale establishments in:

- Making a report on drug distribution to wholesale establishments and medical examination and treatment establishments of level 2 or higher level (quantity manufactured or imported; name and address of establishments having bought the drug, quantity purchased and quantity left at each establishment) and sending it to the Ministry of Health (the Drug Administration of Vietnam) and concerned provincial-level Departments of Health within 7 days from the date the Ministry of Health (the Drug Administration of Vietnam) issues the written request;

- Requesting and coordinating with the quality inspection agency in taking additional samples at the manufacturer, for domestically manufactured drugs, or at the importer, for imported drugs, and at least 2 establishments trading in or using drugs specified in Clause 4 of this Article; sending a report thereon to the Ministry of Health (the Drug Administration of Vietnam) within 15 days from the date the Ministry of Health (the Drug Administration of Vietnam) issues the written request;

- Sending the additionally taken samples to a central-level testing establishment for inspection of quality with regard to the criterion/criteria which the initial samples fail to satisfy.

c/ Based on the testing 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 case samples of a violating drug are taken by a quality inspection agency at a wholesale establishment or a medical examination and treatment establishment of level 2 or higher level (below collectively referred to as wholesale establishment):

a/ Within 24 hours after receiving a test report or an analysis report from a testing establishment, the concerned provincial-level Department of Health shall seal the drug at the establishment where samples are taken;

b/ Within 48 hours after receiving a test report or an analysis report from a testing establishment, the Ministry of Health (the Drug Administration of Vietnam) shall determine the degree of violation and make conclusion on recall of the violating drug in accordance with the provisions of Appendix II to this Circular and issue documents:

- Notifying the recall of the drug in the province or centrally run city where the samples are taken and from establishments trading in or using the drug provided by the wholesale establishment where drug samples are taken as specified in Clauses 3 and 4, Article 12 of this Circular;

- Requesting the registrar, manufacturer or importer to coordinate with the wholesale establishment in:

+ Making a report on drug distribution to wholesale establishments (quantity manufactured or imported; name and address of establishments having bought the drug, quantity purchased and quantity left at each establishment) and sending it to the Ministry of Health (the Drug Administration of Vietnam) and concerned provincial-level Departments of Health within 7 days from the date the Ministry of Health (the Drug Administration of Vietnam) issues the document;

+ Requesting and coordinating with the quality inspection agency in taking at least 2 additional drug samples at drug-trading or -using establishments specified in Clause 4 of this Article; and sending a report thereon to the Ministry of Health (the Drug Administration of Vietnam) within 15 days from the date the Ministry of Health (the Drug Administration of Vietnam) issues the written request;

+ Sending the additionally taken samples to a central-level testing establishment for inspection of quality with regard to the criterion/criteria which the initial samples fail to satisfy.

c/ Based on the testing 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 case drug samples are taken by a quality inspection agency at the manufacturer or importer or a drug storage service provider or drug samples are determined as violating quality regulations due to the manufacture process, or in case samples of a drug batch have been concurrently taken at 2 wholesale establishments, the Ministry of Health (the Drug Administration of Vietnam) shall determine the degree of violation, make conclusion on drug recall as specified in Appendix II to this Circular, and issue a drug recall decision under Clause 3, Article 12 of this Circular. The scope and time of recall must comply with Clause 3, Article 63 of the Law on Pharmacy.

4. Requirements for taking additional samples for quality inspection under Clauses 1 and 2 of this Article:

A drug quality inspection agency shall determine a sampling plan on the basis of a distribution report of the manufacturer or importer; samples shall be taken in the following a-b-c-d-dd order of priority:

a/ Taking drug samples at wholesale establishments in different provinces and cities, including the establishment that has supplied the drug to the establishment where the initial samples are taken;

b/ Taking drug samples at wholesale establishments in different provinces and cities;

c/ Taking drug samples at wholesale establishments in the same province or city;

d/ Taking drug samples at wholesale and retail establishments.

dd/ Taking drug samples at retail establishments.

e/ Drug samples shall be taken under item dd only when the manufacturer or importer can prove that the drug is no longer preserved or stored at wholesale establishments. No additional samples shall be taken for recalled drugs.

5. Processing of testing results of additionally taken samples

a/ If the additionally taken samples meet quality standards, the Ministry of Health (the Drug Administration of Vietnam) shall issue a document determining the degree of violation and the establishment responsible for the violation, and direct the concerned provincial-level Department of Health to dispose of the drug at the retail establishment where initial samples are taken, for the cases specified in Clause 1 of this Article, or the drug at the wholesale establishment and the drug recalled in provinces or cities, for the cases specified in Clause 2 of this Article.

The scope and time of recall must comply with Clause 3, Article 63 of the Law on Pharmacy;

b/ If at least 1 drug sample additionally taken at a retail establishment fails to meet quality standards, except the case specified at Point a of this Clause, the Ministry of Health (the Drug Administration of Vietnam) shall assess risks and issue a document determining the degree of violation and the establishment responsible for the violation, direct the concerned provincial-level Department of Health to dispose of the drugs at the retail establishments where initial samples are taken, and give a warning about drug preservation conditions and drug quality.

c/ If at least 1 (one) drug sample additionally taken at wholesale establishments or all samples additionally taken at retail establishments under Point dd, Clause 4 of this Article fail(s) to meet quality standards, the Ministry of Health (the Drug Administration of Vietnam) shall determine the degree of violation, make conclusion on recall of the violating drug according to the provisions of Appendix II to this Circular, and issue a drug recall decision according to Clause 3, Article 12 of this Circular.”

12. To add the following Point d to Clause 2 of Article 15:

“dd/Counterfeit drugs, smuggled drugs, drugs of unknown origin, expired drugs, drugs containing banned substances, drugs made from inferior materials, drugs subject to destruction according to the Decree on sanctioning of administrative violations in the health sector, and drug samples of which the prescribed retention periods have expired.”

13. To amend and supplement Clause 6 of Article 15 as follows:

“6. Destruction of drugs:

a/ Heads of establishments having to-be-destroyed drugs shall issue decisions on formation of drug destruction councils to organize the drug destruction, decide on destruction methods and supervise drug destruction. Such a council shall be composed of at least 3 persons, including a person in charge of establishments’ professional operations;

b/ The destruction of drugs must guarantee safety for humans and animals and not cause environmental pollution in accordance with the law on environmental protection.

Establishments having to-be-destroyed drugs shall be wholly responsible for drug destruction and send reports and records on drug destruction, made according to Form No. 6 provided in Appendix III to this Circular, to concerned provincial-level Departments of Health.

c/ Destruction of vaccines:

- At least 7 days before destroying vaccines, an establishment in charge of vaccine destruction shall send a written notice of the destruction plan to the concerned provincial-level Department of Health, clearly stating information on the name, quantity, concentration or content of each of the to-be-destroyed vaccines, reasons for destruction, time and place of destruction and destruction method. The provincial-level Department of Health shall supervise vaccine destruction.

- The process of vaccine destruction and the destruction of vaccines must comply with Joint Circular No. 58/2015/TTLT-BYT-BTNMT of December 31, 2015, of the Minister of Health and the Minister of Natural Resources and Environment, on hospital waste management, and the Minister of Natural Resources and Environment’s Circular No. 36/2015/TT-BTNMT of June 30, 2015, on management of hazardous wastes.

- Within 7 days after vaccine destruction completes, the establishment shall send a report on and a record of vaccine destruction to the provincial-level Department of Health and the Drug Administration of Vietnam. The destruction record shall be made according to Form No. 6 provided in Appendix III to this Circular.

d/ The destruction of drugs under special control must comply with Article 48 of Decree No. 54/2017/ND-CP.”

14. To amend and supplement Points b and e, Clause 1 of Article 18 as follows:

“b/ To assume the prime responsibility for, and coordinate with the National Institute of Drug Quality Control, the Institute of Drug Quality Control of Ho Chi Minh City, the National Institute for Control of Vaccines and Biologicals in, formulating a plan on sampling of drugs for quality inspection at establishments that manufacture, prepare, import, export, store, wholesale, retail or use drugs nationwide, and submit it to the Ministry of Health for consideration and approval and for allocation of funds for implementation according to its competence.

To conduct the sampling of drugs for quality inspection under the approved plan and update to the Ministry of Health’s drug quality inspection database the information on drug and drug material samples (including names of drugs and drug materials, concentration, content, forms of preparation, batch number, shelf life, serial number of certificate of registration for marketing authorization or import permit, manufacturers, importers, and establishments where samples are taken) and results of quality inspection of drug and drug material samples;”

“e/ To assume the prime responsibility for, and coordinate with related functional agencies in, translating, publicizing and updating on the Drug Administration of Vietnam’s website the WHO’s guidelines on drug destruction for reference by establishments in the course of selecting drug destruction methods and organizing destruction.”

15. To amend and supplement Point b, Clause 2 of Article 18 as follows:

b/ To formulate plans on sampling of drugs and drug materials for quality inspection at establishments that manufacture, prepare, import, export, store, wholesale, retail or use drugs in provinces and cities, submit them to provincial-level People’s Committees for consideration and approval and for allocation of funds for implementation according to their competence;”

16. To amend and supplementPoint a, Clause 3 of Article 18 as follows:

“a/ Drug testing establishments at the central level (the National Institute of Drug Quality Control, the Institute of Drug Quality Control of Ho Chi Minh City and the National Institute for Control of Vaccines and Biologicals) shall:

- Analyze and test samples for determination of the quality of drugs and drug materials that are manufactured, marketed and used; send reports on test results to the Ministry of Health (the Drug Administration of Vietnam) and provincial-level Departments of Health of the localities where samples are taken;

- Research, establish and publish on their websites and the website of the Drug Administration of Vietnam the list of standard substances, reference standards and standard impurities in service of the analysis and testing of samples of drugs and drug materials that are manufactured, imported, marketed and used in the territory of Vietnam;

- The National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh City shall provide paper or electronic copies of texts on quality standards of drugs and drug materials to provincial-level drug quality control centers in localities as assigned to them;

- The National Institute for Control of Vaccines and Biologicals shall annually review and assess the quality tendency of vaccines and biologicals, and submit to the Drug Administration of Vietnam for revision and subsequent submission to the Ministry of Health for the latter to issue guidelines on ex-works testing of vaccines and biologicals being sera containing antigens or human blood and plasma derivatives, including:

+ General policies on ex-works testing, including policies on testing exemption or reduction for vaccines and biologicals that have been assessed and obtained batch release certificates by SRA.

+ Criteria to be tested for issuance of a quality certificate and time for issuance of a quality certificate for each vaccine or biological); and,

+ A specimen summary file on the manufacture and quality inspection of the vaccine or biological batch for each type of vaccine or biological.

To update information on issuance of certificates of quality of vaccines and biologicals being sera containing antigens or human blood or plasma derivatives on its website and the website of the Drug Administration of Vietnam.”

17. To add the following Point a to Clause 5 of Article 18:

“- To retrieve sampling expenses refunded by business establishments and testing expenses for drug and drug material samples failing to meet quality standards in accordance with law.”

18. To addthe following Point b to Clause 5 of Article 18:

“- To retrieve sampling expenses refunded by business establishments and testing expenses for drug and drug material samples failing to meet quality standards in accordance with law.”

19. To amend and supplement Clause 8, Section I of Appendix I as follows:

“8. Sampling of medicinal materials

1. Medicinal materials or partially processed medicinal materials, including also animals, plants (dried medicinal plants and parts of plants) and minerals, shall be considered uneven materials and sampled according to the provisions in Section I, Clause 9, diagram r of this Appendix.

2. The taking of samples for the purpose of monitoring the quality of medicinal materials by state-run drug quality inspection agencies must comply with regulations of the WHO’s “Guidance on quality control methods for herbal materials 2011”. The sampling of heterogeneous medicinal material batches must comply with Point 1 of this Clause.”

20.To add Form No. 9 on summary file on the manufacture and quality inspection of the vaccine or biological batch to Appendix III to this Circular.

Article 2.Effect

This Circular takes effect on March 16, 2020.

Article 3.Implementation responsibility

The Director General of the Drug Administration of Vietnam, the Chief of the Office, the Chief Inspector, and heads of units under the Ministry of Health, provincial-level Departments of Health, pharmaceutical business establishments, and other related agencies, organizations and individuals shall implement this Circular.

Any problems arising in the course of implementation of this Circular should be reported to the Ministry of Health for consideration and settlement.-

For the Minister of Health
Deputy Minister
TRUONG QUOC CUONG

* All appendices to this Circular are not translated.