Healthcare, medicines & medical devices
Pharmaceutical Wholesaler Permit Requirements and Documents — 165㎡ Warehouse, 500,000,000 won Capital, No Warehouse for the Logistics-Outsourcing Model
Under Article 45 of the Pharmaceutical Affairs Act, anyone other than a pharmacy operator who wants to sell pharmaceuticals or acquire them for sale must obtain a pharmaceutical wholesaler permit. The permit is issued by the mayor, county head or district head with jurisdiction over the business office, and the applicant must have a business office and a warehouse (165㎡ or more in general, 66㎡ or more if handling only imported drugs, reagents and raw-material drugs) and capital or equity of 500,000,000 won or more (200,000,000 won or more if handling only imported drugs, safe household drugs, reagents, raw-material drugs, herbal medicines, etc.). The wholesale business must be managed by a pharmacist, but a wholesaler that outsources storage and delivery to another qualified wholesaler may operate without its own warehouse and business manager. The processing period on the application form is 7 days, and the permit is issued after a facility inspection.
Procedure
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disqualifications in Article 5 of the Pharmaceutical Affairs Act or if 1 year has not passed since a previous permit was revoked.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. 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. 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. 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. 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.
Required documents
- Pharmaceutical wholesaler permit application (Enforcement Rule of the Pharmaceutical Affairs Act, Form No. 17)
- Physician's medical certificate showing the representative is not disqualified for mental illness or drug addiction
- Documents proving the qualification of the wholesale business manager (pharmacist)
- Articles of incorporation and statement of financial position (corporations) or statement of business capital with supporting evidence (individuals)
- Corporate diagnosis report issued by a corporate diagnosis institution
- List of equipment such as delivery vehicles
- Logistics management outsourcing contract (logistics-outsourcing model)
- Letter of authorization (when submitted by an agent)
Fees
Industry range of several hundred thousand won to several million won · We will quote after consultation based on the wholesaler type, whether the warehouse is operated directly or outsourced, whether a new corporation is set up, and the scope of preparation for the Good Supply Practice evaluation. Government fees are separate.
Legal basis and review date
- Pharmaceutical Affairs Act, Article 44
- Pharmaceutical Affairs Act, Article 45
- Pharmaceutical Affairs Act, Article 46
- Pharmaceutical Affairs Act, Article 93
- Pharmaceutical Affairs Act, Article 94
- Enforcement Decree of the Pharmaceutical Affairs Act, Article 31-2
- Enforcement Rule of the Pharmaceutical Affairs Act, Article 36
- Enforcement Rule of the Pharmaceutical Affairs Act, Article 37
- Enforcement Rule of the Pharmaceutical Affairs Act, Article 38
- Enforcement Rule of the Pharmaceutical Affairs Act, Article 39
- Enforcement Rule of the Pharmaceutical Affairs Act, Article 40
- Enforcement Rule of the Pharmaceutical Affairs Act, Article 41
- Enforcement Rule of the Pharmaceutical Affairs Act, Form No. 17
- Rules on the Safety of Medicinal Products, etc., Annex 6
Check these first
- 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.
Frequently asked questions
How large must a pharmaceutical wholesaler's warehouse be?
Can I get a pharmaceutical wholesaler permit without a warehouse?
How much capital does a pharmaceutical wholesaler need?
Can a non-pharmacist run a pharmaceutical wholesale business?
Does an administrative agent handle pharmaceutical wholesaler permit applications?
Contact us
Hwang Yunsang Administrative Office in Songdo, Incheon prepares and submits administrative documents and explains the procedure. If your situation is similar, send us a message.
📍 2697, 26F POSCO Tower-Songdo, 165 Convensia-daero, Yeonsu-gu, Incheon, Republic of Korea · 📞 010-3374-2687 · 🌐 hwangadmin.com
This guide is general information based on public sources. Requirements, documents and deadlines differ by case and by the competent agency, so please confirm them before you proceed.
