What are regulations on drug recall report, evaluation and additional measures in Vietnam?

What are regulations on drug recall report, evaluation and additional measures in Vietnam? (Image from the Internet)

The drug recall report, evaluation and additional measures are prescribed in Clause 6, Article 12 of Circular 11/2018/TT-BYT on Drug/Drug Ingredient Quality issued by the Ministry of Health. To be specific:

In one day (for first-degree recalls) or three days (for second- and third-degree recalls) from the recall’s date of completion, the facility in charge of recalling must report the results to the Ministry of Health (Drug Administration) and the local Department of Health in writing. The report consists of the following documents:

- Summary drug recall report, which follows Template No. 5 of Appendix III issued together with this Circular.

- List of drug traders/users (including those receiving drugs from the facility in charge of recalling unconformable drugs, or from distributors) with their addresses, phone numbers, email addresses (if any), amount of drugs received, amount of drugs recalled;

- Delivery reports, receipts of return or other evidence of drug recall;

- Drug recall self-evaluation form;

- Investigation results, evaluation of causes, evaluation of risks in the unconformable drug's other batches and/or other drugs coming from the same production line.

The Ministry of Health (Drug Administration) consider the report mentioned in Point a of this Clause, evaluate it or send it to the Department of Health for evaluation. If the drug recall is evaluated to be insufficient and the product can still be circulated and used, posing a risk to the consumers' health, the Drug Administration cooperates with the Department of Health and other related authorities in coercive drug recall.

Above is the consulting content.