Procedures for issuance of Certificate of Eligibility for Drug Business to wholesaler or retailer of herbal ingredients in Vietnam

According to Article 24 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 wholesaler or retailer of herbal ingredients are as follows:

- A wholesaler or retailer of herbal ingredients 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 the Service of Health of the province where their headquarters are located.

- 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, the Service of Health shall establish an inspectorate to verify the application, carry out an inspection at the facility, and issue an inspection record.

Within 10 working days after the inspection record is issued, the Director of the Service of Health shall issue, reissue, renew, or expand the Certificate of Eligibility for Drug Business. If the application is rejected, the Service of Health 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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