The previous form Information for application Art. 13 TPA has been divided into two forms: one specifically for veterinary medicinal products and the other for human medicinal products
Market surveillance measures based on safety signals or quality defects in the original medicinal product must also be implemented for parallel imported medicinal products
Optimisation of the application procedure for the implementation of a fast-track authorisation procedure and the implementation of temporary authorisation
From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation
From 1 September 2024, Swissmedic is accepting SEND data sets for applications for new authorisation for human medicinal products with new active substances
