From which sources do competent entities receive information on unconformable drugs in Vietnam? How to notify drug recall decision in the compulsory form?

May I ask: How to identify the violation’s seriousness? How to notify drug recall decision in the compulsory form? Question of Mr. Thang from Binh Dinh.

How to identify the violation’s seriousness?

Pursuant to Clause 2, Article 12 of Circular No. 11/2018/TT-BYT stipulating identification of the violation’s seriousness as follows:

- In 24 hours from the time the information on unconformable drugs mentioned in Points a, c, d, dd and e, Clause 1 Article 12 of Circular No. 11/2018/TT-BYT, the Ministry of Health (Drug Administration of Vietnam) shall identify the violation’s seriousness and draw conclusions on drug recall, based on evaluation of consumer health's risks.

If the drug registration advisory board's opinion is requested for identification of the violation’s seriousness, as specified in Section IV, Appendix II issued together with this Circular, the time limit of identification of violation's seriousness will be 7 days.

- The seriousness of a drug’s violation is specified in Appendix II issued together with Circular No. 11/2018/TT-BYT;

- For information on unconformable drugs mentioned in Point b, Clause 1 of this Article, the handling shall be carried out in accordance with Article 14 of Circular No. 11/2018/TT-BYT.

From which sources do competent entities receive information on unconformable drugs in Vietnam? How to notify drug recall decision in the compulsory form?

From which sources do competent entities receive information on unconformable drugs in Vietnam? How to notify drug recall decision in the compulsory form? (Image from the Internet)

From which sources do competent entities receive information on unconformable drugs in Vietnam?

Pursuant to Clause 1, Article 12 of Circular No. 11/2018/TT-BYT stipulating as follows:

Compulsory drug recall procedure
1. Receiving information on unconformable drugs:
The Ministry of Health (Drug Administration of Vietnam) receives information on unconformable drugs as follows:
a) Information on drugs that do not guarantee effective treatment or is unsafe from the drug registration advisory board or post-vaccination complication handling advisory board;
b) Information on drug quality criteria that are not met from drug testing facilities;
c) Information on discovered unconformable drugs from the Drug Administration, Health/Pharmaceutical inspection authority;
d) Unconformable foreign drug notices from manufacturers, pharmaceutical and drug quality inspection authorities;
dd) Information on unconformable drugs from public security, customs and market surveillance;
e) Drug information from pharmacy business establishments requesting voluntary drug recall.
...

Thus, according to the above regulations, the Ministry of Health (Drug Administration of Vietnam) receives information on unconformable drugs as follows:

- Information on drugs that do not guarantee effective treatment or is unsafe from the drug registration advisory board or post-vaccination complication handling advisory board;

- Information on drug quality criteria that are not met from drug testing facilities;

- Information on discovered unconformable drugs from the Drug Administration, Health/Pharmaceutical inspection authority;

- Unconformable foreign drug notices from manufacturers, pharmaceutical and drug quality inspection authorities;

- Information on unconformable drugs from public security, customs and market surveillance;

- Drug information from pharmacy business establishments requesting voluntary drug recall.

How to implement compulsory drug recall?

Pursuant to Clause 5, Article 12 of Circular No. 11/2018/TT-BYT stipulating the implementation of compulsory drug recall as follows:

- The drug trader/user must discontinue provision and use of the recalled drugs; place inventory drugs in quarantine; make a list of drug traders/users and individuals (if any) that purchased those drugs, contact them and receive the returned drugs; return the drugs to the providers;

- The manufacturer (of domestic drugs) and importer cooperate with the import entrustor or distribution hub (of imported drugs) in recalling unconformable drugs. The recall form follows Template No. 4 of Appendix III issued together with Circular No. 11/2018/TT-BYT.

The drug trader/provider that fails to recall drugs or receiving returned drugs shall be notified by facilities and individuals purchasing those drugs to the local Department of Health and face actions.

- Drug recall has to be completed within one of the time limits specified in Clause 3, Article 63 of the 2016 Law on Pharmacy.

How to notify drug recall decision in the compulsory form?

Pursuant to Clause 4, Article 12 of Circular No. 11/2018/TT-BYT stipulating the notification of drug recall decision in the compulsory form as follows:

- The drug recall decision of the Ministry of Health (Drug Administration) is announced by post, fax, email, telephone or the mass media. The scope of drug recall announcement is specified in Clause 3, Article 63 of the 2016 Law on Pharmacy;

- Immediately after making the recall decision, the Ministry of Health (Drug Administration) announces the drug recall decision on websites of the Ministry of Health and the Drug Administration, and the Ministry of Health’s national pharmaceutical database;

Departments of Health announce drug recall decisions on their websites immediately after receiving those decisions.

Domestic drug manufacturers and importers must notify the information about recalled drugs to drug traders/users which purchased those drugs.

- For recalling drugs with first-degree violations, besides carrying out the actions specified in Point b Clause 4, Article 12 of Circular No. 11/2018/TT-BYT, the Ministry of Health must announce the drug recall decision on Vietnam Television and Voice of Vietnam.

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