In South Korea, medicinal product manufacturing business requires a manufacturer to secure a manufacturing business license and market authorization from the Ministry of Food and Drug Safety (MFDS) for each product to be manufactured and distributed.

Under the Pharmaceutical Affairs Act (PAA), a manufacturer cannot apply for a manufacturing business license if he/she does not have at least one (01) product for which he/she is applying for marketing authorization.

In other words, a manufacturer is required to simultaneously submit a Marketing Authorization Application (MAA) for at least one (01) product, to be eligible to submit a manufacturing business license application.

Separate restrictions apply to narcotics and medication ingredients from those of pharmaceuticals. For each product that will be produced or imported in accordance with the Narcotics Control Act, a manufacturer or importer must get a narcotics manufacturing or importing business license and marketing authorization from the MFDS.

The ingredient must be registered with the MFDS to manufacture or import, use in medications, or use in drug ingredients designated by the MFDS. It will be assumed that the registered drug ingredients have received marketing authorization.

Conditions

To qualify for a manufacturing business license, an applicant is required to fulfill the following requirements:

• Procure a manufacturing site with the following facilities and equipment:
  • a workroom for manufacturing work
  • a laboratory to control the quality of raw materials, materials, and products.
  • a depository for keeping raw materials, materials, and products
  • facilities and appliances necessary for manufacturing and quality control
• Appoint a Representative Director without disqualifying factors as prescribed under the PAA
• Appoint one or more pharmacists or physicians as Drug Safety Managers and one or more pharmacists as Manufacturing Managers
• Secure one or more marketing authorizations

The MFDS has established Good Manufacturing Practices (GMP) for medicinal products. When applying for marketing authorization for a product, relevant materials required for the GMP evaluation must also be submitted with the MAA.

Restrictions on foreign applicants

A foreign manufacturer of medicinal products can apply for a manufacturing business license through his/her South Korean affiliate or a subsidiary.

To know more about other Regulatory systems and their elements in South Korea, contact our experts at Freyr Solutions.