Renewals: Regulatory and procedural guidance
This page lists the European Medicines Agency's regulatory and procedural guidance documents on renewals of marketing authorisation.
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Guideline on the processing of renewals in the centralised procedure (PDF/311.38 KB)
Adopted
First published: 04/08/2016
Last updated: 04/08/2016
Legal effective date: 01/11/2016
EMEA/CHMP/2990/00 Rev.5 -
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Guideline on the processing of renewals in the centralised procedure: document with track changes (PDF/334.54 KB)
Draft: consultation closed
First published: 28/07/2015
Last updated: 04/08/2016
Consultation dates: 28/07/2015 to 14/09/2015
EMEA/CHMP/2990/00 Rev.5 -
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Overview of comments received on ‘Guideline on the processing of renewals in the centralised procedure (PDF/398.42 KB)
First published: 04/08/2016
Last updated: 04/08/2016
EMA/723788/2015 -
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Guideline on the processing of renewals in the centralised procedure (PDF/165.17 KB)
Adopted
First published: 20/10/2005
Last updated: 02/07/2012
Legal effective date: 02/07/2012
EMEA/CHMP/2990/00 rev. 4 -
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Overview of comments received on 'guideline for the processing of renewals in the centralised procedure' (PDF/451.91 KB)
First published: 02/07/2012
Last updated: 02/07/2012
EMA/257975/2012 -
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Overview of external comments received, and European Medicines Agency / Committee for Medicinal Products for Human Use feedback / action on each comment on guideline on the processing of renewals in the centralised proced... (PDF/155.2 KB)
First published: 24/10/2005
Last updated: 24/10/2005
Legal effective date: 20/11/2005
EMEA/CHMP/2990/00 rev. 3 -
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Reflection paper criteria for requiring one additional five-year renewal for centrally authorised medicinal products (PDF/31.87 KB)
Adopted
First published: 15/11/2007
Last updated: 15/11/2007
Legal effective date: 01/12/2007
EMEA/131973/2006 -
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Overview of comments received on draft guideline on criteria for requiring one additional five-year renewal for centrally authorised medicinal products (EMEA/131973/2006) (PDF/55.47 KB)
First published: 29/01/2008
Last updated: 29/01/2008
EMEA/29922/2008