Handling Non-Standard Quality Drugs According to Sampling Locations

In cases where drug samples in violation are taken by quality control agencies at retail pharmacies, grade III, and grade IV medical examination and treatment facilities:

- Within 24 hours from the time of receiving the test certificate or analysis certificate sent by the testing facility, the Department of Health shall seal off the substandard drugs at the facility from which the sample was taken;

- Within 48 hours from the time of receiving the test certificate or analysis certificate sent by the testing facility, the Ministry of Health (Drug Administration) shall issue a written request to the registration facility, production facility, or import facility to:- Report on the distribution of drugs to the Ministry of Health (Drug Administration);- Request the quality control agency to take supplementary samples at domestic production facilities or import facilities for foreign drugs and at least 02 wholesale facilities, including the wholesale facility that supplied the drugs to the facility where the sample was taken;- Send the collected samples to the central testing facility for quality testing of the substandard criteria.- In the event that at least 01 (one) supplementary drug sample does not meet quality standards, the Ministry of Health (Drug Administration) determines the level of violation and concludes the recall of the violating drugs by issuing a recall decision as per legal regulations. The scope and time for recall are implemented according to legal provisions.

- In the event that the supplementary drug samples meet quality standards, the Ministry of Health (Drug Administration) shall determine the level of violation, conclude the recall of the violating drugs, and issue a recall decision and handling for the drugs from the initially sampled facility.

In cases where drug samples in violation are taken by quality control agencies at wholesale facilities, grade II and above medical examination and treatment facilities:

- Within 24 hours from the time of receiving the test certificate or analysis certificate sent by the testing facility, the Department of Health shall seal off the substandard drugs at the facility from which the sample was taken;

- Within 48 hours from the time of receiving the test certificate or analysis certificate sent by the testing facility, the Ministry of Health (Drug Administration) issues a decision to recall the drugs in the province, centrally-run city where the sample was taken, and from the business facilities that have been supplied by the wholesale facility where the drug sample was taken, and issues a written request to the registration facility, production facility, or import facility to:- Report on the distribution of drugs to the Ministry of Health (Drug Administration);- Request the quality control agency to take at least 02 supplementary drug samples at other wholesale facilities, including the wholesale facility that supplied the drugs to the facility where the sample was taken;- Send the collected samples to the central testing facility for quality testing of the substandard criteria.

In cases where at least 01 (one) supplementary drug sample does not meet quality standards, the Ministry of Health (Drug Administration) determines the level of violation and concludes the recall of the violating drugs and issues a recall decision.

In cases where drug samples are taken by quality control agencies at production facilities, import facilities, storage service business facilities, or drug samples identified as violating quality due to production process issues, the Ministry of Health (Drug Administration) determines the level of violation and concludes the recall of the violating drugs and issues a recall decision. The scope and time for recall are implemented according to legal provisions.

See detailed Circular 11/2018/TT-BYT effective from June 20, 2018.

-Thao Uyen-

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