04 Groups of Drugs Required to be Tested Before Circulation

Thuy Phu

08:59, 11/07/2024

On May 4, 2018, the Ministry of Health issued Circular 11/2018/TT-BYT regulating the quality of drugs and medicinal ingredients.

Notably, it is mandatory to conduct drug testing before circulation for the following 04 cases:

- Vaccines and biological products containing antibodies (as prescribed in Points a, b Clause 4 Article 103 of the Pharmaceutical Law);- Biological products derived from human blood and plasma;- Imported drugs (as prescribed in Article 70 of Decree 54/2017/ND-CP);- Drugs produced by foreign manufacturing facilities included in the list of manufacturing facilities with quality violations published by the Ministry of Health.

Drug testing must be conducted by a testing facility qualified and designated by the Ministry of Health.

In case the testing facility is not qualified to perform certain tests in the testing process, it must notify and cooperate with the manufacturing or importing facility to send samples for testing at another qualified testing facility.

Circular 11/2018/TT-BYT takes effect from June 20, 2018, and abrogates Circular 09/2010/TT-BYT and Circular 04/2010/TT-BYT.

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