Pharmaceutical Manufacturing Business Permit Application Procedure and Documents — Manufacturing Facility Standards, Manufacturing Manager and Conditional Facility Permit

Procedure

1. 1. Check disqualifications and the type of permit

   An applicant who falls under the disqualifications in Article 5 of the Pharmaceutical Affairs Act, or for whom 1 year has not passed since a manufacturing permit was revoked, cannot obtain a permit (Article 31(8) of the same Act). Manufacturing only quasi-drugs requires a manufacturing report, and selling pharmaceuticals that underwent clinical trials by commissioning another manufacturer without your own site requires a contract manufacturing and sales business report under Article 31(3), so first decide which procedure applies.

2. 2. Equip the manufacturing facility

   The manufacturing site must have a workroom for manufacturing, a laboratory for quality control of raw materials, packaging materials and products, a storage area for raw materials, packaging materials and products, and the facilities and equipment needed for manufacturing and quality control (Decree on Facility Standards, Article 3(1)). Facilities used to make products other than pharmaceuticals may substitute for pharmaceutical facilities if they meet the same standards and there is no risk of cross-contamination. If the plant is being built or renovated, a conditional facility permit can be applied for before the facilities are complete (Pharmaceutical Affairs Act, Article 35(1)).

3. 3. Appoint a manufacturing manager

   Each manufacturing site must have the necessary number of pharmacists or herbal pharmacists managing manufacturing (Pharmaceutical Affairs Act, Article 36(1)). For the manufacture of biological products, management may be entrusted to a physician approved by the Minister of Food and Drug Safety or a technical expert with bacteriological knowledge. Enter the manager's name, license number and license type in the application and attach qualification documents or the manufacturing manager approval.

4. 4. Prepare the application and file it with the Regional Office

   Enter the site name and location, applicant, manufacturing manager, item names and any concurrent business in the pharmaceutical manufacturing business permit application (Form No. 1), attach the applicant's medical certificate (proving the applicant is not a person with a mental disorder or a drug addict) and the manager's qualification documents, and file it with the head of the Regional Office of Food and Drug Safety with jurisdiction. The corporate register and pharmacist license are checked by the official through shared administrative information. The fee is the amount announced by the Minister of Food and Drug Safety.

5. 5. Review, on-site inspection and issuance of the permit

   The Regional Office reviews the documents, conducts an on-site inspection if needed, processes the application within 25 days, and issues a manufacturing business permit (Form No. 9) if approved. With a conditional facility permit, notify the office once the facilities are complete, and the head of the Regional Office checks compliance with the condition within 20 days from the notification. After the permit, Good Manufacturing Practice (GMP) must be observed, and changes to permitted matters require a change permit or change report.

Required documents

• Pharmaceutical manufacturing business permit application (Rules on Safety of Pharmaceuticals, Etc., Form No. 1)
• Applicant's medical certificate (not a person with a mental disorder under Article 5, subparagraph 1 of the Pharmaceutical Affairs Act, or a specialist's certificate under the proviso of that subparagraph, and not a narcotics, cannabis or psychotropic drug addict under subparagraph 3)
• Documents confirming the qualification of the manufacturing manager or the manufacturing manager approval (same Rules, Article 42(3))
• For a conditional facility permit: documents confirming ownership or right of use of the land for new construction, or of the building for an existing building
• Manufacturing facility status materials (layout of the workroom, laboratory and storage area, and list of manufacturing and quality control facilities and equipment)
• Items checked by the official: corporate register (corporations only), pharmacist license (when the manager is a pharmacist; submit a copy if you do not consent)

Fees

Industry range from several hundred thousand won to around one million won · Quoted after consultation depending on the scope of facility status materials, whether a conditional facility permit is sought, and whether item permit or item report documents are prepared together. The government permit fee is the amount announced by the Minister of Food and Drug Safety.

See fees and official charges for this service →

Legal basis and review date

• Pharmaceutical Affairs Act, Article 5
• Pharmaceutical Affairs Act, Article 31
• Pharmaceutical Affairs Act, Article 35
• Pharmaceutical Affairs Act, Article 36
• Pharmaceutical Affairs Act, Article 38
• Pharmaceutical Affairs Act, Article 93
• Rules on Safety of Pharmaceuticals, Etc., Article 2
• Rules on Safety of Pharmaceuticals, Etc., Article 13
• Rules on Safety of Pharmaceuticals, Etc., Article 39
• Rules on Safety of Pharmaceuticals, Etc., Article 40
• Rules on Safety of Pharmaceuticals, Etc., Form No. 1
• Rules on Safety of Pharmaceuticals, Etc., Form No. 9
• Decree on Facility Standards for Manufacturers and Importers of Pharmaceuticals, Etc., Article 3

Checked against the statutes on 2026-10-14

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• A person for whom 1 year has not passed since a manufacturing permit was revoked or the site was closed cannot obtain a permit again (Pharmaceutical Affairs Act, Article 31(8)2), so check the disposition history first when applying after acquiring an existing company.
• Manufacturers must observe Good Manufacturing Practice (GMP), including in-house testing (Pharmaceutical Affairs Act, Article 38(1)), so it is safer to prepare laboratory operation and the quality control system from the application stage.

Frequently asked questions