Vietnam: Documents about revocation of certificates of traditional drug/herbal material marketing authorization

Certificates of traditional drug/herbal material marketing authorization shall be revoked in some certain cases.

According to Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, documents about revocation of certificates of traditional drug/herbal material marketing authorization include:

- A copy of the decision on the recall of traditional drug/herbal material in the cases where the traditional drug/herbal material is recalled as prescribed in Points a and b Clause 1 Article 58 of the Law on Pharmacy of Vietnam.

- A copy of the decision on the revocation of the certificate of pharmaceutical product that is revoked by a foreign competent authority in the cases where the traditional drug/herbal material is recalled as prescribed in Point c Clause 1 Article 58 of the Law on Pharmacy of Vietnam.

- A certified true copy of the record of administrative violation against regulations on traditional drugs/herbal materials in the cases where the traditional drug/herbal material is recalled as prescribed in Points d and dd Clause 1 Article 58 of the Law on Pharmacy of Vietnam.

- Originals of documents proving that the herbal material or traditional drug containing the herbal material that is not recommended by WHO or a Vietnamese competent authority or its country of origin in terms of safety and efficacy in the cases where the traditional drug/herbal material is recalled as prescribed in Point e Clause 1 Article 58 of the Law on Pharmacy of Vietnam.

- An application form for revocation of the certificate of traditional drug/herbal material marketing authorization made by the manufacturer or the applicant using the Form No. 11 in the Appendix I hereof in the cases where the traditional drug/herbal material is recalled as prescribed in Point g Clause 1 Article 58 of the Law on Pharmacy of Vietnam.

View details about the procedures for revocation of certificates of traditional drug/herbal material marketing authorization at the Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, effective from October 28, 2018.

- Thanh Lam -

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