21. Juni 2024 – Swissmedic has simplified the requirements for renewed authorisation of medicinal products. First authorisation of a medicinal product is usually issued for a period of five years (Art. 16 para. 2 Therapeutic Products Act [TPA]). 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 renewal application process. Now, a cover letter confirming the documentation's consistency with the originally authorised product is sufficient. Additional documents from Module 1 and scientific documentation (Modules 2–5) are no longer required.

The revised guidance document and the updated directory of required documents reflect these changes, effective from 15 June 2024.

For more information, see here.