Clarification of the submission date for an authorisation application for a fast-track authorisation procedure (FTP) or the implementation of temporary authorisation (temp.auth./temp.AI)
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
