FROM MARCH 16, RECALLED DRUGS OF UNKNOWN ORIGIN SHALL BE DESTROYED
On January 22, 2020, the Minister of Health issues the Circular No. 03/2020/TT-BYT on amending and supplementing a number of Article of the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of health on the quality of drugs and drug materials.
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.
