2 min read

Ensuring the quality and safety of imported pharmaceutical products is a key priority for the Ministry of Food and Drug Safety (MFDS) in South Korea. To maintain strict Regulatory oversight, South Korea requires the registration of overseas pharmaceutical manufacturing sites.

This article provides a comprehensive guide on the process, requirements, and key considerations for pharmaceutical companies looking to register their overseas manufacturing facilities with the MFDS.

Why is Registration Required? 

Overseas manufacturing site registration is a mandatory requirement for companies importing pharmaceutical products into South Korea. The process ensures compliance with Good Manufacturing Practice (GMP) standards and enhances product traceability. Any foreign manufacturer intending to export finished or raw pharmaceutical products for domestic manufacturing must be registered with the MFDS.

Steps to Register an Overseas Manufacturing Site

1. Initial Registration Process 

  • The overseas manufacturing facility’s name and location must be registered with MFDS.
  • The registration applies to all imported pharmaceutical products, whether drug products or drug substances.
  • If there are multiple manufacturing sites for a single imported product, each site must be registered individually.
  • Even if another importer has already registered with the same overseas manufacturer, each importer must complete a separate registration.

2. Change Registration 

  • If there are any modifications to the registered information (such as facility relocation, name change, or structural modifications), a change registration is required.
  • This process ensures that the latest facility details are recorded and aligned with South Korean Regulatory requirements.

3. Fees and Processing Time 

  • The registration fee for electronic submissions is 141,000 KRW.
  • For in-person or mail submissions, the fee is 148,000 KRW.
  • The processing time for applications is up to 30 days, with possible extensions if additional documentation is required.

Key Documents Required for Registration 

To complete the registration process, the following documents must be submitted:

  • Application Form: A filled registration form for overseas manufacturing sites. If applying through the electronic civil service system, a separate submission of this form is not required.
  • Document that can prove the registration of the importer(applicant): Documents verifying the importer for pharmaceuticals.
  • Overseas Manufacturing Site Details: Official documents verifying the name, location, contact details and status of the foreign facility.
  • Site Master File (SMF): A summary document covering manufacturing processes, personnel, quality control measures, and facility details. This is required for certain imported products as per South Korean regulations.
    • If the same manufacturing site has already been registered by another importer, the submission of SMF can be waived by sharing the permit statement letter from the other importer or overseas manufacturing site.

Importance of Compliance and Good Manufacturing Practice (GMP) 

Maintaining compliance with MFDS regulations is critical for continued market access. Overseas manufacturers must adhere to South Korean GMP requirements, ensuring product safety, efficacy, and quality. The MFDS may conduct inspections to verify compliance before granting registration approval.

Conclusion

The registration of overseas pharmaceutical manufacturing sites in South Korea is an essential regulatory step for importers. By understanding the requirements, streamlining document submission, and ensuring GMP compliance, companies can navigate the process efficiently. Staying updated with MFDS guidelines will help pharmaceutical firms maintain uninterrupted market access and compliance with South Korean regulations.

How Freyr Can Help

Freyr is a global regulatory solutions provider with deep expertise in MFDS regulations. From document preparation to regulatory submissions, Freyr streamlines overseas manufacturing site registration, ensuring seamless market entry into South Korea.

For expert guidance on MFDS compliance, connect with Freyr today.