Application for issuance of Certificate of Eligibility for Drug Business in Vietnam

According to Article 22 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, the composition of an application for issuance, reissuance, renewal, expansion of Certificate of Eligibility for Drug Business submitted by a provider of herbal ingredient preservation services, herbal ingredient wholesaler or retailer is specified in Clause 6 Article 1 of Decree No. 89/2012/ND-CP of Vietnam’s Government.  

The document forms are provided in Appendix 01a, 01b, 01c, 01d enclosed with Circular No. 03/2016/TT-BYT. Notably, technical documents mentioned in Point c Clause 6 Article 1 of Decree No. 89/2012/ND-CP of Vietnam’s Government are as follows:

1. For providers of herbal ingredient preservation services:

- A diagram of location and design of the warehouse;

- List of preservation equipment of the facility and goods preserved in the warehouse.

2. For wholesalers:

- Documents about herbal ingredient storage: A diagram of location and design of the warehouse, List of preservation equipment of the facility and the goods preserved in the warehouse.

- Documents about herbal ingredient distribution: A diagram of the facility's organizational structure including the distribution system (headquarters, branches, warehouses, agents). The diagram must specify the names, positions, qualifications of managers of the facility and its departments; List of vehicles. If herbal ingredients are transported under a contract, it is required to have documents about the contractor's identity, preservation equipment, and vehicles.

- List of personnel (the form in Appendix 02 enclosed herewith).

3. For retailers:

- A diagram of location and design of areas where herbal ingredients are displayed and stored.

- List of personnel (the form in Appendix 02 enclosed herewith).

- If the facility applies for a Certificate of Eligibility for Drug Business that covers commercial drugs, other ingredients, and herbal ingredients, only one application specified in Clause 1 and Clause 2 Article 22 of the Circular No. 03/2016/TT-BYT is required and only one Certificate of Eligibility for Drug Business shall be issued.

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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