Post-authorisation
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.
| Guidance for specialised areas |
|---|
| Guidance on interacting with EMA |
|---|
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. New or revised Q&As are labelled 'New' or 'Rev' respectively together with the relevant date.
-
List item
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (PDF/2.46 MB) (updated)
First published: 01/07/2009
Last updated: 13/11/2023
EMEA-H-19984/03 Rev. 106 -
List item
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (PDF/2.46 MB) (updated)
First published: 09/12/2013
Last updated: 13/11/2023
EMEA-H-19984/03 Rev. 106