What documents are needed for revocation of certificates of traditional drug/herbal material marketing authorization in Vietnam?

What documents are needed for revocation of certificates of traditional drug/herbal material marketing authorization in Vietnam?

Pursuant to Article 33 of the Circular 21/2018/TT-BYT stipulating documents that are needed for revocation of certificates of traditional drug/herbal material marketing authorization in Vietnam as follows:

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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

What are procedures for revocation of certificates of traditional drug/herbal material marketing authorization in Vietnam?

Pursuant to Article 34 of the Circular 21/2018/TT-BYT stipulating procedures for revocation of certificates of traditional drug/herbal material marketing authorization in Vietnam as follows:

1. Within 30 days from the date on which the Traditional Medicine Administration of Vietnam receives the documents specified in Clauses 1, 2, 3 and 4 Article 33 of this Circular from competent authorities, applicant or manufacturer, the Director of the Traditional Medicine Administration of Vietnam shall issue a decision on revocation of the certificate of traditional drug/herbal material marketing authorization.

2. Within 30 days from the date on which the manufacturer or applicant submits the application form prescribed in Clause 5 Article 33 of this Circular to the Traditional Medicine Administration of Vietnam, the Director of the Traditional Medicine Administration of Vietnam shall issue a decision on revocation of the certificate of traditional drug/herbal material marketing authorization.

What are regulations on rejection of applications for issuance and extension of the certificate of traditional drug/herbal material marketing authorization in Vietnam?

Pursuant to Article 35 of the Circular 21/2018/TT-BYT stipulating rejection of applications for issuance and extension of the certificate of traditional drug/herbal material marketing authorization in Vietnam as follows:

1. Applications for issuance and extension of the certificate of traditional drug/herbal material marketing authorization shall be rejected as prescribed in Clauses 2, 3 and 4 Article 100 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for the implementation of the Law on Pharmacy.

2. The Minister of Health shall authorize the Director of the Traditional Medicine Administration of Vietnam to issue a decision on rejection of applications for issuance and extension of the certificate of traditional drug/herbal material marketing authorization.

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