Recently (01 October, 2024) Swissmedic released an updated guidance "Transfer of Marketing Authorisation" which provides detailed instructions and procedures for transferring the rights of a marketing authorisation for medicinal products in Switzerland. This process is crucial for companies that wish to transfer their authorisation to another legal entity, ensuring the continuity of product availability in the Swiss market.
Marketing Authorisation Transfer:
The transfer of marketing authorisation refers to the legal process by which the rights to market a medicinal product are transferred from one entity (the original authorisation holder) to another (the new authorisation holder). This may occur during mergers, acquisitions, or other business transitions.
Swissmedic published this guidance to clarify to third parties which requirements need to be met according to its practice. The guidance applies to applications for transfer of authorisations for medicinal products to new marketing authorisation holders for the Infrastructure, Medicinal Product Authorisation and Vigilance, and Medicinal Product Licences and Surveillance Divisions.
The transfer of the authorisation comprises the transfer of all rights and obligations associated with the marketing of a medicinal product. The authorisation status of a medicinal product is not affected by the transfer to a new marketing authorisation holder. The future marketing authorisation holder must submit to Swissmedic at least three months before the planned transfer date a written application requiring approval to transfer the authorisations from the previous (current) marketing authorisation holder to a new one (the applicant).
The application must contain:
A declaration of assignment bearing the legally valid signatures (as shown in the entry in the Commercial Register) of the previous marketing authorisation holder, stating the name of the medicinal products to be transferred, incl. planned transfer date;
The form Transferring an authorisation completed in full by the future marketing authorisation holder (the applicant).
The guidance outlines the step-by-step process to initiate and complete the transfer:
Application Submission: The original authorisation holder must submit a transfer request to Swissmedic.
Required Documents: Key documents include a transfer agreement, proof of legal succession (if applicable), and updated product information.
Evaluation by Swissmedic: Swissmedic assesses the application, ensuring that the new authorisation holder has the necessary qualifications and infrastructure to market the product responsibly.
Approval: Upon successful review, Swissmedic issues approval, officially transferring the marketing authorisation to the new entity.
After the transfer, the new holder assumes full responsibility for the product, including manufacturing, quality control, pharmacovigilance, and compliance with Swissmedic regulations.
For more detailed information, refer to the Swissmedic Guidance Document.
Also check out this guidance "SwissPAR" that was released last week, designed to demonstrate the principles on the basis of which Swissmedic creates and publishes SwissPARs. The SwissPAR is a summary, public evaluation report drafted by Swissmedic that relates to an authorisation procedure.
Comments