Veterinary Drug Wholesaler Permit and Veterinary Quasi-Drug Import Reporting

Procedure

Procedure

1. 01

   Confirm items handled and the permit scope: Decide whether only veterinary drugs are handled, whether human drugs will also be sold, and whether veterinary quasi-drugs will be imported. Handling human drugs as well changes the warehouse area standard, so fix the business scope first.

2. 02

   Check the office and warehouse: Under Article 45(2)(ii) of the Act, a warehouse handling only veterinary drugs must be at least 33㎡. Confirm the area and storage layout with the lease, building register use and floor plan, and ask the local government about detailed facility standards in advance.

3. 03

   Prepare qualification documents for the representative and managing pharmacist: Both obtain a physician's certificate showing they do not fall under Article 5, subparagraphs 1 and 3 of the Act. If the representative is a pharmacist who manages the business directly, no separate managing pharmacist documents are submitted.

4. 04

   Prepare and submit the wholesaler permit application: Submit the application (Form No. 14) with the certificates, the articles of incorporation for a corporation, and a list of delivery vehicles and equipment to the Mayor, County Governor or District Head of the business location. After the local government checks the site, a permit (Form No. 15) is issued.

5. 05

   Prepare the import business report and import manager documents: To import quasi-drugs, submit the import business report (Form No. 12-2) with two physician's certificates, the import manager approval or qualification documents, and a facility and equipment statement for import and quality control to the Director of the Animal and Plant Quarantine Agency. Aquatic-only items fall under the National Fishery Products Quality Management Service.

6. 06

   Prepare item import permit or report documents: Together with the import business report, a permit application or import report must be filed at the same time for at least one item. Oral care, disinfectant and similar quasi-drugs need an import permit, while fiber and rubber products need an import report, so prepare manufacturing and sales certificates (issued within two years) per item.

Filing route

Filing route

Deadlines & processing notes

Deadlines & processing notes

Basic documents

Basic documents

The wholesaler permit is a prior permit, not a report, so buying or selling veterinary drugs before the permit is issued is unlicensed business, and a warehouse under 33㎡ cannot be permitted even after the lease and construction are finished.