Marketing authorisation
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
In this section
| General requirements for all applications | Particular application types |
|---|---|
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Applying for European Union marketing authorisation for medicinal products for human use (PDF/289.34 KB)
First published: 29/03/2011
Last updated: 18/05/2015 -
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Procedural advice to CHMP members (PDF/177.89 KB)
Adopted
First published: 06/08/2008
Last updated: 06/08/2008
EMEA/361945/2007 -
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Procedural advice on the re-examination of CHMP opinions (PDF/147.62 KB)
Draft: consultation closed
First published: 12/02/2009
Last updated: 12/02/2009
EMEA/CHMP/50745/2005 Rev.1
The full text is available as a
booklet