Circular 03/2020/TT-BYT amending Circular 11/2018/TT-BYT on quality of drugs
From March 16, recalled drugs of unknown origin shall be destroyed
Accordingly, this Circular supplements the case of destruction of recalled drug, such as: Counterfeit drugs, smuggled drugs, drugs of unknown origin, expired drugs, drugs containing banned substances, drugs manufactured from materials do not meet quality standards, drugs subject to destruction as prescribed in the Decree on sanction of administrative violations in health sector, drug samples which have the duration of storage expired.
In addition, the Ministry of Health (the Drug Administration of Vietnam) shall assign testing establishment satisfies standard of Good Laboratory Practices (GLP) to carry out the drug testing, including:
Firstly, the service establishment of testing of drugs and drug materials which possesses the Certificate of eligibility for pharmacy business with the scope in testing of drugs.
Secondly, the drug testing establishment which satisfies the GLP affiliated to the Stringent Regulatory Authorities (SRA - Stringent Regulatory Authorities) or be assigned by this authority to carry out the testing of drugs and drug materials to serve the operation of drug quality management...
This Circular takes effect on March 16, 2020.
For further details of the Circular 03/2020/TT-BYT, Click here
translation of the Official Gazette of the Vietnam News Agency
THE MINISTRY OF HEALTH
THE SOCIALIST REPUBLIC OF VIETNAM
Hanoi, January 22, 2020
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
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.