Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing Authorisation" in Switzerland. This document provides instructions and requirements for transferring ownership of a marketing authorisation for a medicinal product from one company or individual to another.
This guidance document describes the requirements and preconditions (including the documentation to be submitted) for an application to transfer authorisations for human and veterinary medicinal products.
Swissmedic published the guidance document to clarify the requirements that need to be met according to its practice.
This guidance document applies to applications for the transfer of marketing authorisations to new marketing authorisation holders in the Infrastructure, Authorisation and Market Surveillance divisions.
Moreover, the guidance document provides information on the deadline for submitting the application, the fees associated with the transfer, the consequences of the transfer, as well as the documentation required to support the application. Also, the guidance document outlines the new owner's responsibilities, including ensuring product quality, safety, and effectiveness.
Once the authorisation is transferred, the new holder is responsible for publishing information for healthcare professionals and patient information texts correctly.