This guidance is intended to provide transparency regarding the structure of applications in order to facilitate efficient and efficient processing and to ensure compliance with Swissmedic's policies and procedures.
The document provides an overview of the legal basis, the structure and content of the application dossier, the electronic format and the submission methods. The guidance also clarifies the roles and responsibilities of the applicants, and the Swiss Agency for Therapeutic Products (Swissmedic).
Life cycle following the transfer of authorisation:
After the authorisation of a medicinal product has been transferred, it is preferable to continue using the existing submission format (particularly in the case of eCTD).
Option 1: The existing MAH transfers the eCTD life cycle to the new MAH. The new MAH continues using the existing eCTD life cycle.
Option 2: The existing MAH does not transfer the eCTD life cycle to the new MAH. The new MAH submits the authorisation transfer on paper and continues using the life cycle as eCTD after the transfer. The transfer is consolidated in the new life cycle. However, a baseline will be required for certain sections of the dossier (e.g. module 3).
Option 3: The existing MAH does not transfer the eCTD life cycle to the new MAH. The new MAH submits the transfer on paper and continues using the life cycle on paper after the transfer of the medicinal product.
Swissmedic will assess whether conditions have been fulfilled in accordance with the decision letter separately and invoice them separately.
Click this LINK to know more in detail about the requirements such as Submission formats, Time limits, Mandatory submission requirements etc.