Comprehensive Guide to License Transfer in South Korea

Introduction

In South Korea, the transfer of a license for medicinal products involves the process of transferring the marketing authorization (MA) of a medicinal product from one holder to another. This process, regulated by the Ministry of Food and Drug Safety (MFDS), ensures that the new marketing authorization holder (MAH) is fully qualified to maintain the safety, efficacy, and quality of the medicinal product.

Importance of Marketing Authorization (MA)

Marketing Authorization (MA) is a fundamental Regulatory requirement that guarantees the safety, efficacy, and quality of medicinal products. It involves a rigorous evaluation process by Regulatory authorities and is essential for bringing new medicines to market while protecting public health.

Role of a Marketing Authorization Holder (MAH)

A Marketing Authorization Holder (MAH) is an entity, usually a pharmaceutical company, that holds the marketing authorization (MA) for a medicinal product. This entity is legally responsible for the product on the market and ensures that it complies with Regulatory standards.

Overview of the Procedure and Requirements for License Transfer in South Korea

1. Initiation of the Transfer Process
   • The transfer process begins with the current MAH applying to the MFDS.
   • The application must include a transfer application form, an agreement between the current and new MAH, and detailed information about the new MAH’s qualifications and facilities.
2. Documentation Requirements
   • The MFDS requests multiple documents for the transfer process, including, but not limited to, the original marketing authorization certificate, the dossier, a certificate of Good Manufacturing Practice (GMP), and other required documents.
3. Review and Approval
   • The MFDS carefully reviews the application to ensure that the new MAH complies with all Regulatory requirements.
   • Upon successful review, the MFDS approves the transfer and issues a new marketing authorization certificate to the new MAH.
4. Continuous Compliance
   • The new MAH must ensure continuous compliance with all Regulatory requirements set by the MFDS.

Have more questions? Our experts are here to explain.

To give a detailed perspective on license transfers in South Korea, Freyr has scheduled a free webinar with our experts from South Korea on “Strategic Guide for License Transfers in South Korea”, scheduled for September 26, 2024. The timings are as follows: