Swissmedic establishes the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents
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
