EMA: Updated EMA Post-authorisation procedural advice guidance
This guidance addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the EMA position on issues, which are typically addressed in discussions or meetings with MAHs in the Post-Authorisation phase. This guidance information and fruitful pre-submission dialogue between MAHs and the EMA should enable MAHs to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated and processed speedily.
Źródło wiadomośći: http://www.ema.europa.eu/htms/human/postguidance/index.htm