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20-8 · Healthcare, medicines & medical devices

Pharmaceutical Manufacturing Permit Application (Including Conditional Facility Permit)

Anyone who intends to manufacture pharmaceuticals as a business must, under Article 31(1) of the Pharmaceutical Affairs Act, meet the facility requirements of the Enforcement Decree on Facility Standards for Manufacturers and Importers of Pharmaceuticals and obtain a manufacturing permit from the Regional Office of Food and Drug Safety with jurisdiction over the manufacturing site. Facility requirements cover a work area, testing laboratory, storage area, and the equipment needed for manufacturing and quality control, and each site must have a pharmacist or herbal pharmacist as manufacturing manager (Article 36). Persons falling under the disqualifications of Article 5, or whose manufacturing permit was revoked less than 1 year ago, cannot obtain a permit (Article 31(8)); if the plant is still under construction, a conditional facility permit under Article 35(1) may be requested. Because the permit covers the manufacturing site only, each product to be sold requires a separate product approval or product notification.

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#Pharmaceutical Manufacturing Permit Application (Including Conditional Facility Permit)#Official check#20-8
🌐 Pharmaceutical Manufacturing Business Permit Application Procedure and Documents
01

Procedure

Procedure

  1. 01

    Confirm the permit type: operating your own site requires a manufacturing permit, manufacturing quasi-drugs only requires a manufacturing report, and selling products made by another manufacturer requires a contract-manufacturing distributor report. Check the Article 5 disqualifications and whether 1 year has passed since any revocation.

  2. 02

    Review site facilities: organize floor plans and equipment lists showing the work area, testing laboratory, storage area, and manufacturing and quality control equipment required by Article 3 of the Facility Standards Decree. Facilities for other products may substitute only if they meet the same standards and pose no cross-contamination risk.

  3. 03

    Appoint a manufacturing manager: assign a pharmacist or herbal pharmacist to each site and prepare license documents. For biological products, a physician or bacteriology specialist approved by the Minister of Food and Drug Safety may manage manufacturing, in which case the manager approval certificate is attached.

  4. 04

    File the application: submit the application (Form No. 1 of the Enforcement Rules on the Safety of Pharmaceuticals) with the applicant's medical certificate and the manager's qualification documents to the Regional Office, and pay the fee set by MFDS notice. If the plant is not yet complete, apply for a conditional facility permit on the same form with proof of ownership or right of use of the land or building.

  5. 05

    Supplements, inspection, and permit issuance: respond to supplement requests and on-site inspection, then receive the manufacturing permit certificate (Form No. 9). Under a conditional facility permit, notify the Regional Office once facilities are complete; it checks fulfillment within 20 days of notification.

02

Filing route

Filing route

Submit in person, by mail, or online via the Nedrug e-civil service to the Regional Office of Food and Drug Safety with jurisdiction over the manufacturing site.

Confirm the current filing office, jurisdiction, and online availability on the official website.

Official check
Actual processing agencyCompetent Korean authority or official service
Statutory and policy authorityMinistry of Food and Drug Safety
Online routeCompetent Korean authority or official service
03

Deadlines & processing notes

Deadlines & processing notes

Check deadlines and next steps against the notice, filing date, and any request for additional documents.Official check
04

Basic documents

Basic documents

Basic documents0 / 7

A manufacturing permit alone does not allow you to make and sell pharmaceuticals without product approval or notification, so schedule the first product's approval or notification together with the permit application to avoid delaying operations.

Scope of services

Scope of services

Hwang Yunsang Administrative Agent Office prepares and translates documents for administrative agencies, submits them on your behalf, and guides you through permit, application, and notification procedures. Services that require the principal’s personal appearance, principal’s application, or electronic signature may be limited in delegation.