top of page

Risk management plan (RMP): questions and answers

This page is intended to provide advice to Marketing Authorisation Holders of centrally authorised medicinal productsabout procedural and regulatory aspects to the Risk Management Plan (RMP) lifecycle during the post authorisation phase. It addresses the classification of changes to the RMP, submission requirements and aspects to be considered in the management of parallel procedures affecting RMP. 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