Vietnam: The time limit for issuing a certificate of marketing authorization of traditional medicines is not more than 06 months

Vietnam: The time limit for issuing a certificate of marketing authorization of traditional medicines is not more than 06 months (Illustrative image)

According to Article 71 of the Law on Pharmacy 2016, the registration, sale, and recall of traditional medicines being sold on the market in Vietnam shall comply with the regulations. Therefore, the time limit for issuing, renewing, and modifying a certificate of marketing authorization of traditional medicines in Vietnam:

a) 06 months from the receipt of the satisfactory application for issuance of a certificate of marketing authorization of traditional medicines;

b) 12 months from the receipt of the satisfactory application for issuance of a certificate of marketing authorization or a traditional medicine that requires clinical trial;

c) 01 month from the receipt of the satisfactory application for renewal or moditification of a certificate of marketing authorization of traditional medicines;

d) Where an application for issuance, renewal, or modification of a certificate of marketing authorization of traditional medicines is rejected, or any of the conditions for it is not satisfied, a written explanation must be provided.

Note: Traditional medicines prepared and prescribed within a health facility specified in Clause 1 and Clause 2 Article 70 of this Law are not required to be registered. The head of the health facility in Vietnam is responsible for recalling medicines that are found unqualified, unsafe, or ineffective.

Details may be found in Law on Pharmacy 2016 effective from January 01, 2017.

Ty Na

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