top of page

Regulatory information - Management of changes to risk management plans and certain quality aspects

New post-authorisation guidance is published today

The European Medicines Agency (EMA) has published today new guidance on the procedural management of risk management plans (RMP) submissions and on the classification of changes to the marketing authorisation post authorisation. Both guidance documents introduce simplified procedures for marketing authorisation holders.

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