South Korea Pharmaceutical Licensing

This record covers only pharmacy retail, pharmaceutical wholesale and local manufacture of human medicines in South Korea. South Korea is not a federal state: MFDS and its regional food and drug offices handle manufacturing and product matters, while cities, counties and districts handle pharmacy registration and accept wholesale applications for business premises under the current rules.

The sources opened do not fully specify general foreign ownership limits, minimum capital or a uniform corporate form; company incorporation, taxation, land use and foreign investment access must be verified separately.

— Assess the 3 types of business activity separately.

— Does not automatically cover product items, individual qualifications, imports/exports, controlled medicines or general corporate compliance.

Article 31 of the Pharmaceutical Affairs Act places manufacturing business licences and product-item licences/notifications for manufacture and sale within the MFDS framework; its regional food and drug offices handle manufacturing licences, changes and facility investigations. Procedures for pharmacy and wholesale business premises cannot be replaced by the manufacturing application channel.

— MFDS: manufacturing, product assessment and GMP.

— Regional food and drug offices: manufacturing licences, changes and facility investigations.

— Cities, counties and districts: pharmacy registration and acceptance of applications for wholesale business premises.

A pharmacist or Korean herbal pharmacist (한약사) intending to open a pharmacy must apply for establishment registration to the mayor, county head or district head. Government24 lists online, in-person and postal applications and a 7-day processing period; pharmacist licences may be verified administratively, while Korean herbal pharmacists must submit a copy or present the original.

The materials opened do not specify nationally uniform floor area requirements, distances from medical institutions, fixed pharmacist staffing ratios, initial registration fees, validity periods or renewal rules; all should be confirmed with the authority responsible for the business premises.

— Applicant: a pharmacist or Korean herbal pharmacist.

— Pharmacy registration does not confer wholesale, import, product or controlled-medicine authorisation.

Article 36 of the Enforcement Rules requires medicine wholesalers to apply to the mayor, county governor or district head for the locality of their business establishment and submit documents concerning the manager's qualifications, finances/capital, enterprise assessment, vehicles and equipment, and outsourced distribution where applicable. The older Government24 service page describes the level of the responsible authority differently; before submitting an application, confirm with the local authority under the current rules.

Except for Korean herbal medicines, medical high-pressure gases and radiopharmaceuticals, wholesale licences must carry the condition that sales may take place only after compliance with pharmaceutical distribution quality management standards has been determined. KGSP assessment documentation includes warehouse plans, equipment, storage and supply processes, and quality/hygiene and complaint systems.

— Managers must submit evidence of qualifications; the specific qualifications require separate verification.

— The KGSP assessment service page states 50 days and no service fee; it does not replace product or controlled-medicine procedures.

Businesses manufacturing medicines must obtain an MFDS licence in accordance with facility standards; to sell medicines they manufacture, they must also obtain a product-item licence or submit a notification for manufacture and sale for each item. Government24 lists acceptance by regional food and drug offices, 25 days for a standard licence, manufacturing manager and premises documentation, and fees in accordance with MFDS notices; MFDS also has pharmaceutical GMP regulations.

— Manufacturing business licensing, GMP and product-item procedures are handled at separate levels.

— Notification for contracted manufacture and sale is not an entitlement automatically included in an ordinary manufacturing licence.

Pharmacy applicants must be pharmacists or Korean herbal pharmacists; wholesale applications must include evidence of the wholesale business manager's qualifications; manufacturing applications must include evidence of the manufacturing manager's qualifications or an approval document, with a pharmacist licence submitted only where the manager is a pharmacist. The available materials do not support describing all managers as having a particular academic qualification, nationality or pharmacist status, and do not cover recognition of foreign qualifications.

— Pharmacy: individual licences and business registration are separate.

— Wholesale: wholesale business manager.

— Manufacturing: manufacturing manager.

Manufacturing premises must meet facility standards, and land/building ownership or lease documents must be submitted; MFDS includes GMP assessment and inspection of domestic manufacturing premises in the process. Wholesale KGSP assessment requires warehouse/business premises plans, equipment, storage arrangements for designated medicines, supply processes and quality and hygiene documentation. No nationally uniform numerical floor area or layout requirements were found for pharmacies.

— Manufacturing: facilities, ownership/lease documentation and GMP review.

— Wholesale: storage arrangements, equipment, storage and supply quality systems.

— Pharmacy: confirm requirements applicable to the business premises.

Pharmacy applications may be made online, in person or by post; wholesale rules allow electronic documents and designate the city, county or district where the business premises are located, while the old Government24 page lists only in-person/postal applications; manufacturing applications may be made online, in person or by post to the regional food and drug office. Documentation is not interchangeable: pharmacy applications focus on licences, wholesale applications on managers, businesses and equipment, and manufacturing applications on managers and premises; products require separate procedures.

— First determine the application channel according to the activity and premises.

— Prepare business, personnel, premises and product documentation separately.

Government24 states: 7 days for new pharmacy registration, but no fee is listed; 7 days and KRW 20,000 for wholesale (the page was last verified in 2018); generally 25 days for manufacturing, with fees according to MFDS notices. Change pages state 7 days/KRW 5,000 for pharmacies, 7 days/KRW 10,000 for wholesale, and 15 days for manufacturing. The materials opened do not provide a uniform validity period or renewal frequency for the 3 types of licence; processing periods are not guaranteed overall approval timeframes.

— Reconfirm with the receiving authority or the applicable notice before paying fees.

— Do not promise fixed review, supplementary submission or approval timeframes.

Wholesalers must maintain the KGSP compliance conditions attached to their licences; the assessment page requires at least 15 days of KGSP implementation and submission of quality, hygiene, facility, supply and complaint documentation. Manufacturers must comply with GMP, and regional food and drug offices handle manufacturers' suspension and resumption matters. Separate notification services exist for suspension, closure and resumption of pharmacies/sales businesses; that page states 3 days for pharmacy resumption and 7 days for other sales businesses.

— Wholesale: storage, traceability, quality/hygiene and complaint records.

— Manufacturing: GMP, facility investigations and suspension/resumption notifications.

Applications for pharmacy relocation or name changes must be made 3 days before the change date; changes to wholesale licence particulars require a licence amendment; changes to prescribed manufacturing particulars require a licence amendment through the regional food and drug office. Separate notification of succession to business status applies to transfers, acquisitions, inheritance and mergers of sales businesses. Wholesale transfers and acquisitions require licence, transaction and business diagnostic documentation, demonstrating that a transaction does not constitute automatic transfer of a licence.

— Pharmacy: advance amendment for relocation/name changes.

— Wholesale: licence amendments and applicable succession notifications.

— Manufacturing: licence amendments for prescribed particulars.

A manufacturing licence does not replace product procedures: Article 31 requires a licence or notification for each product item before self-manufactured medicines may be sold. MFDS explains that safety, efficacy, quality and GMP are assessed; documentation requirements differ for new drugs, generic drugs and imported drugs.

Narcotic drugs and precursor substances are handled through separate services covering imports and exports, manufacturing, wholesale and other activities; narcotic drug wholesale documentation must include a pharmacy registration certificate or wholesale licence, demonstrating that ordinary business authorisation does not automatically cover controlled medicines. A complete official route covering general imports, exports and individual cross-border consignments has not been obtained, so no uniform route can be provided.

— Products: a licence or notification for each product item.

— Cross-border activities and controlled medicines: separate verification and procedures.