First authorisation of a medicinal product is usually issued for a period of five years (Art. 16 para. 2 TPA, SR 812.21). Five years after first authorisation, the authorisation holder must submit a once-only application for renewal of authorisation. If the authorisation holder misses the deadline for submission of the application for renewal of authorisation, there is the option of submitting an application for renewed authorisation in order to still maintain authorisation.
Swissmedic has simplified the requirements for the application for renewed authorisation. It is now sufficient to send a cover letter confirming that the documentation, including all additions approved since, is identical to that of the authorised medicinal product for which the renewed authorisation application is being submitted and complies with the requirements of therapeutic legislation. Other documents from Module 1 and scientific documentation (Modules 2–5) are now no longer required.
The Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (ZL201_00_001) has been revised accordingly and the Directory Overview of documents to be submitted (ZL000_00_006) has been updated.
The revised Guidance document and updated Directory are valid with effect from 15 June 2024.