EMA Posts Revised Integrated Guidance on Use of Centralized Procedure
Posted 18 April 2012 | By
The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure.
EMA's 18 April revision of the Q&A document represents its 21st revision, and is a comprehensive resource including information from a wide range of regulations and guidances.
"This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization procedures," explains EMA. "It provides an overview of the Agency's position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorization phase."
The document contains questions and answers grouped into 18 categories, which include marketing and cessation notification, transparency, transfer of marketing authorization, periodic safety update reports, follow-up measures, renewal of a marketing authorization, annual reassessments and more.
EMA - European Medicines Agency post-authorisation procedural advice for users of the centralised procedure