THE MINISTRY OF HEALTH | | THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness |
No. 03/2020/TT-BYT | | Hanoi, January 22, 2020 |
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.”
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[1] Công Báo Nos 735-736 (3/8/2020)