Pharmaceutical wholesale licence and KGSP assessment

Procedure

Procedure

1. 01

   1. Decide the drugs to handle and the wholesaler type — The permit states the wholesaler type, such as general wholesale, imported drug wholesale, safe household drug wholesale, reagent wholesale, raw-material drug wholesale or herbal medicine wholesale. Because the warehouse area and capital requirements differ by scope, decide first what you will sell. A permit cannot be granted if the representative (the representative director for a corporation) falls under the disqualifications in Article 5 of the Pharmaceutical Affairs Act or if 1 year has not passed since a previous permit was revoked.

2. 02

   2. Prepare the business office, warehouse and capital — The warehouse must be 165㎡ or more, 66㎡ or more if handling only imported drugs, reagents and raw-material drugs, and 33㎡ or more if handling only veterinary drugs. The warehouse needs cold storage and light-shielding facilities, rodent and pest prevention facilities, and temperature and humidity control facilities, plus dedicated storage if handling biological products or narcotics. Capital or equity must be 500,000,000 won or more, or 200,000,000 won or more for certain items only, proven by a corporate diagnosis report from a corporate diagnosis institution.

3. 03

   3. Appoint a wholesale business manager or arrange logistics outsourcing — A pharmaceutical wholesaler must have a pharmacist manage its business, and a representative who is a pharmacist may manage it directly. If storage and delivery are outsourced to another wholesaler with a warehouse net floor area of 800㎡ or more that is designated as a Good Supply Practice compliant business (excluding wholesalers that are also manufacturers or importers), the wholesaler may operate without its own warehouse and business manager. In that case, the outsourcing contract is attached to the application and the contracted wholesaler keeps a business manager.

4. 04

   4. Submit the application and undergo the facility inspection — Submit the pharmaceutical wholesaler permit application to the city, county or district office with jurisdiction over the business office, attaching the articles of incorporation (corporations), the representative's medical certificates, documents proving the business manager's qualification, a statement of financial position or a statement of business capital, a corporate diagnosis report, and a list of equipment such as delivery vehicles. The fee is 20,000 won and the processing period on the form is 7 days, and the office issues the permit after a facility inspection and review.

5. 05

   5. Start sales after the Good Supply Practice compliance decision — A wholesaler permit, except for herbal medicines, medical high-pressure gases and radiopharmaceuticals, carries the condition that sales may begin only after a decision that the business complies with the Korea Good Supply Practice (KGSP). To apply for the compliance evaluation, the business must have applied the standard for 15 days or more before the application date, and the city, county or district office issues a compliance certificate after an on-site inspection. If the business office, representative or manager changes after the permit, file an application for a change permit or a report of change of the wholesale business manager.

Filing route

Filing route

Deadlines & processing notes

Deadlines & processing notes

Fees & official charges

Fees & official charges

Included in the basic fee — Initial document review, required-document guidance, basic form preparation, one filing support and responses to up to two supplement requests.

Conditional success fee — For this service, any conditional success fee may be separately agreed within the lawful service scope and stated in a written engagement agreement. No outcome is guaranteed.

Displayed amounts are starting estimates, not statutory or standard rates. The final fee is confirmed after consultation and document review in the engagement agreement. Government fees and actual expenses may change.

Basic documents

Basic documents

Selling pharmaceuticals without a permit, or obtaining a permit or change permit by false means, is punishable by imprisonment of up to 5 years or a fine of up to 50,000,000 won, so do not start trading before you receive the permit and the compliance decision. The Good Supply Practice compliance evaluation required by the permit condition needs 15 days or more of application before the evaluation request, so prepare the standard manuals and records right after the permit.