Pharmaceutical Wholesale License in Korea

Does pharmaceutical wholesale require a permit?

Yes. As a rule, only a pharmacy operator may sell pharmaceuticals or acquire them for sale, and a licensed pharmaceutical wholesaler is an exception that may sell or acquire them. A person who wants to become a pharmaceutical wholesaler must obtain a permit from the head of the si/gun/gu as prescribed by Ordinance of the Ministry of Health and Welfare, and a change permit is also required when permitted matters change.

What are the requirements for a pharmaceutical wholesale license?

(1) Facilities: a business office and a warehouse are required, and the warehouse must be 165 m² or more (66 m² or more if only imported drugs, reagents or active pharmaceutical ingredients are handled; 33 m² or more if only veterinary drugs are handled; no area standard if only herbal medicines, medical high-pressure gases or radiopharmaceuticals are handled). The warehouse needs facilities for cold storage and light shielding, protection against rodents and pests, and temperature and humidity control, and, depending on the products handled, storage for biological products, narcotics and psychotropic drugs, and so on.

(2) Assets: capital or equity must be KRW 500 million or more (KRW 200 million or more if only certain products such as imported drugs, safety OTC medicines, reagents, active pharmaceutical ingredients or herbal medicines are handled).

(3) Personnel: a licensed pharmaceutical wholesaler must appoint a pharmacist to manage the business (not required if the wholesaler is a pharmacist and manages it directly).

(4) Disqualification: medical certificates must show that the representative is not a person with a mental disorder (except where a specialist finds them fit), a person under adult or limited guardianship, or a person addicted to narcotics, cannabis or psychotropic drugs.

Which documents are needed?

Attach the following to the pharmaceutical wholesaler application form. Corporation: articles of incorporation, the representative's medical certificates, documents confirming the wholesale manager's qualification, a statement of financial position, a corporate diagnosis report from a corporate diagnosis institution, a list of equipment held such as delivery vehicles, and a distribution management outsourcing contract (if outsourced). Individual: the representative's medical certificates, a statement of business capital (with supporting evidence), and the wholesale manager's qualification documents, corporate diagnosis report, equipment list and so on. The corporate register certificate is checked by the head of the si/gun/gu through shared administrative information.

What is the procedure?

(1) Decide the products to handle (general, imported, herbal, high-pressure gases, etc.) → (2) secure the business office and warehouse and fit out the facilities → (3) secure the capital and obtain a corporate diagnosis → (4) appoint a pharmacist as wholesale manager → (5) submit the application and documents → (6) receive the permit certificate. Except for wholesalers of herbal medicines, medical high-pressure gases and radiopharmaceuticals, the permit carries a condition that products may be sold only after a finding of conformity with the pharmaceutical distribution quality management standards, and the permit is notified to the head of the national pharmaceutical management information center within 15 days of the permit date.

How long does it take?

The application form states a processing period of 7 days. Time for facility work, the corporate diagnosis and the distribution quality conformity assessment is separate.

Which authority receives the application?

Apply to the head of the si/gun/gu with jurisdiction over the business office.

Why is an application rejected or a permit revoked?

Typical reasons are failing the business office or warehouse facility standards, insufficient capital, no pharmacist wholesale manager, or a disqualification. Obtaining a permit or change permit by fraud or other improper means is a ground for revocation and can lead to imprisonment of up to 5 years or a fine of up to KRW 50 million. Selling pharmaceuticals without being a pharmacy operator or a licensed wholesaler carries the same level of penalty.

What can an administrative agent help with?

YouSun Administrative Agency prepares the application and attachments, reviews the requirements and submits them to the authority on your authorization. Pharmacist work (dispensing, medication counselling), distribution quality standards consulting or facility construction, and corporate diagnosis belong to specialist institutions or qualified professionals and are not handled. Work restricted by other laws cannot be handled, and litigation or court representation is outside the scope of an administrative agent and is not offered. Whether a permit is granted is decided by the competent authority.