Legal Counselling

Compositions of application for issuance of a certificate of traditional drug marketing authorization in Vietnam

15:55, 15/10/2018

Recently, the Ministry of Health of Vietnam has issued Circular No. 21/2018/TT-BYT on marketing authorization of traditional drugs and herbal materials.

According to new regulations, application for issuance of a certificate of traditional drug marketing authorization includes:

- Administrative documents.

- Technical documents.

- A sample label of the traditional drug sold at the home country or reference country (for imported traditional drugs).

Besides, according to Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, an application for extension of the certificate of traditional drug marketing authorization includes:

- An application form.

- Documents specified in Clauses 2 and 3 Article 16 of this Circular and documents specified in Clauses 6 and 7 Article 16 of this Circular if the traditional drug has its administrative documents changed on the extension date.

- A report on sale of the traditional drug.

- A report on safety and efficacy of the drug if its safety and efficacy still has to be monitored.

- A copy of the issued certificate of drug marketing authorization in Vietnam.

Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from October 28, 2018.

- Thanh Lam -

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