The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. This is known as the post-authorisation stage of the product lifecycle.
The information in this section sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls.
United Kingdom's (UK) withdrawal from the European Union (EU)
EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK's withdrawal from the EU.
In this section
|Guidance for specialised areas|
Question-and-answer (Q&A) document
EMA's post-authorisation procedural advice document provides a printable overview in Q&A format of EMA's position on issues typically addressed with marketing authorisation holders.
EMA regularly updates the Q&A to reflect new developments, additional guidance and the implementation of new European legislation. A track-changes version shows the latest updates:
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes
New or revised Q&As are labelled 'New' or 'Rev' respectively together with the relevant date.
In other sections
Marketing authorisation holders should also consider the regulatory information in the sections below: