Procedures for issuance of Certificate of Eligibility for Drug Business to a provider of herbal ingredient preservation services in Vietnam

According to Article 23 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, procedures for issuance of Certificate of Eligibility for Drug Business to a provider of herbal ingredient preservation services are as follows:

A provider of herbal ingredient preservation services shall submit 01 application for issuance, reissuance, renewal, or expansion of the Certificate of Eligibility for Drug Business specified in Article 22 of this Circular to Traditional Medicine Administration of Vietnam  - Ministry of Health.

Notably, after receiving the application, the receiving body shall issue a note of receipt (the form provided in Appendix 03 enclosed herewith).

If the application is not satisfactory, within 10 working days from the day on which it is received, the receiving body must request the applicant to complete the application.

Within 10 working days from the day on which the satisfactory application is received, Traditional Medicine Administration of Vietnam shall establish an inspectorate to verify the application, carry out an inspection at the facility providing herbal ingredient preservation services, and issue an inspection record.

Within 10 working days after the inspection record is issued, the Director of Traditional Medicine Administration of Vietnam shall issue, reissue, renew, or expand the Certificate of Eligibility for Drug Business. If the application is rejected, the Traditional Medicine Administration of Vietnam shall provide an explanation in writing.

View more details at the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, issued on January 21, 2016.

Le Vy

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