Handling of Violating Drug Samples Taken from Retail Pharmacies, Healthcare Facilities at Level 3, 4

To be specific, Clause 11 Article 1 Circular 03/2020/TT-BYT amends Clause 1 Article 14 of Circular 11/2018/TT-BYT, stipulating the handling of cases of drug sample violations collected by quality inspection agencies at retail drug establishments, third-tier and fourth-tier medical examination and treatment establishments (hereinafter referred to as retail establishments) as follows:

Illustration (source: internet)

- Within 24 hours from the time of receiving the test report or analysis report from the testing facility, the Department of Health shall seal the substandard drugs at the sampling establishment;

- Within 48 hours from the time of receiving the test report or analysis report from the testing facility, the Ministry of Health (Drug Administration) shall issue a document requesting the registration establishment, production establishment, or import establishment to cooperate with the wholesale distribution establishment:

+ Report the distribution situation of drugs to the wholesale establishment, second-tier or higher medical examination and treatment establishments (production and import quantities; the names and addresses of the establishments that purchased the drugs, purchased quantities, and residual quantities at each establishment) and send it to the Ministry of Health (Drug Administration) and the local Department of Health within a maximum period of 07 days from the date the Ministry of Health (Drug Administration) issues the request document;+ Request and cooperate with quality inspection agencies to take additional samples at the domestic production establishment for domestic drugs or the import establishment for foreign drugs and at least 02 business establishments using the drugs as stipulated in Clause 4 of this Article; and send the implementation report to the Ministry of Health (Drug Administration) within a maximum period of 15 days from the date the Ministry of Health (Drug Administration) issues the request document;+ Send the taken samples to the central testing facility for quality testing of the unqualified index.

Subsequently, based on the testing results of the additional drug samples, the Drug Administration shall handle as follows:

- In cases where the additional drug samples meet the quality standards, the Ministry of Health (Drug Administration) shall issue a document determining the level of violations, the establishment responsible for the violation, and direct the Department of Health to handle the drugs at the retail establishment where the initial samples were taken in the “Case of drug sample violations collected by quality inspection agencies at retail drug establishments, third-tier and fourth-tier medical examination and treatment establishments” or the wholesale establishment and the drugs recalled within the province or city area in the “Case of drug sample violations collected by quality inspection agencies at wholesale establishments, second-tier or higher medical examination and treatment establishments.”

- In cases where at least 01 additional drug sample taken at the retail establishment does not meet quality standards, except for the case as stipulated in point a of this Clause, the Ministry of Health (Drug Administration) shall assess the risk, issue a document determining the level of violations, the establishment responsible for the violation, direct the Department of Health to handle the drugs at the retail establishments where the samples were taken, and warn about the storage conditions and quality of the drugs.

- In cases where at least 01 (one) additional drug sample taken at the wholesale establishment or all additional drug samples taken at the retail establishment do not meet quality standards, the Ministry of Health (Drug Administration) shall determine the level of violations and conclude on the withdrawal of violative drugs as stipulated in Appendix II attached to this Circular, issuing the decision to withdraw the drugs as stipulated in Clause 3 Article 12 of this Circular.

See more regulations in Circular 03/2020/TT-BYT effective from March 16, 2020.

Thu Ba

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