Renewals: Regulatory and procedural guidance

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This page lists the European Medicines Agency's regulatory and procedural guidance documents on renewals of marketing authorisation.

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Document(s) Language Status First published Last updated Effective Date
Guideline on the processing of renewals in the centralised procedure (English only) adopted 2016-08-04   2016-11-01
Guideline on the processing of renewals in the centralised procedure: document with track changes (English only) draft: consultation closed 2015-07-28 2016-08-04  
Overview of comments received on ‘Guideline on the processing of renewals in the centralised procedure (English only)   2016-08-04    
Guideline on the processing of renewals in the centralised procedure (English only) adopted 2005-10-20 2012-07-02 2012-07-02
Overview of comments received on 'guideline for the processing of renewals in the centralised procedure' (English only)   2012-07-02    
Overview of external comments received, and European Medcines Agency / Committee for Medicinal Products for Human Use feedback / action on each comment on guideline on the processing of renewals in the centralised procedure (English only)   2005-10-24   2005-11-20
Reflection paper criteria for requiring one additional five-year renewal for centrally authorised medicinal products (English only) adopted 2007-11-15   2007-12-01
Overview of comments received on draft guideline on criteria for requiring one additional five-year renewal for centrally authorised medicinal products (EMEA/131973/2006) (English only)   2008-01-29