top of page

Post-authorisation safety studies: questions and answers

This page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation safety studies (PASSs). It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.

Click on this link for more information.


Today's News
Follow us
  • LinkedIn Social Icon
  • Vimeo Social Icon
Newsletter on Pharma Legislation
the newsletter of
bottom of page