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October 2024
Swissmedic has issued guidance (ZL404_00_001) outlining the legal framework and process for transferring marketing authorizations of both human and veterinary medicinal products in Switzerland. This guidance, effective from 01-May-2023, is based on Article 10 of the Therapeutic Products Ordinance (TPO) and the FeeO-Swissmedic.
Key Requirements for Transfer of Marketing Authorizations:
Written Application:
A written transfer application must be submitted at least three months prior to the intended transfer.
The application should include:
A declaration of the intention to transfer the marketing authorization.
A completed HMV4 form, which provides detailed information on the marketing authorization transfer.
New Holder’s Responsibilities:
Upon approval of the transfer, the new holder of the marketing authorization assumes all rights and obligations related to the product.
This includes responsibilities for ensuring batch release and maintaining compliance with applicable regulations.
Transitional Arrangements:
To facilitate the transfer, sticker updates may be applied to product packaging and healthcare information, allowing for a smoother transition between the old and new holder.
Transfer Fees:
Transfer fees are outlined in the FeeO-Swissmedic, which specifies the costs associated with submitting the transfer application and ensuring compliance with regulatory requirements.
Swissmedic’s Role:
Swissmedic may verify compliance throughout the transfer process to ensure that all requirements are met before the new holder can legally market the product.
This process ensures that marketing authorizations are correctly transferred while maintaining safety and compliance standards for medicinal products in Switzerland.
Region: Switzerland
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