Marketing-authorisation procedures for advanced-therapy medicinal products

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The European Medicines Agency provides procedural and guidance documents to help companies applying for a marketing authorisation for advanced therapy medicinal products (ATMPs). 

Questions relating specifically to the authorisation of ATMPs may be submitted to advancedtherapies@ema.europa.eu.

Table of contents


Dossier requirements and submission dates

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Document(s) Language Status First published Last updated Effective Date
Dossier requirements for centrally authorised products (English only)   2009-06-26 2017-02-24  

Procedural advice on the evaluation of ATMPs

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Document(s) Language Status First published Last updated Effective Date
Procedural advice on the evaluation of advanced therapy medicinal products in accordance with article 8 of Regulation (EC) No 1394/2007 (English only) draft: consultation closed 2009-03-31    

Guideline on the risk-based approach according to Annex I, part IV of Directive/2001/83/EC applied to advanced therapy medicinal products

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Procedural advice on the re-examination of Committee for Medicinal Products for Human Use opinion

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Document(s) Language Status First published Last updated Effective Date
Procedural advice on the re-examination of CHMP opinions (English only) draft: consultation closed 2009-02-12    

Procedural advice on the consultation of notified bodies in the case of a combined ATMPs

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