Post opinion: Regulatory and procedural guidance
Table of contents
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The linguistic review process of product information in the centralised procedure - Human (PDF/188.9 KB)
First published: 15/10/2008
Last updated: 24/07/2017
EMEA/5542/02 Rev. 5.1* -
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Guidance document on voting in the framework of discussion and adoption of CHMP opinions (PDF/42.59 KB)
First published: 01/06/2008
Last updated: 01/06/2008
CPMP/3137/01 Rev 1.1 -
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EMEA publication policy of CPMP summaries of opinion (PDF/40.16 KB)
First published: 08/06/2001
Last updated: 08/06/2001
CPMP/1635/01 -
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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 -
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Overview of comments received on draft guideline on procedures for re-examination of CHMP opinions (PDF/61.82 KB)
First published: 26/06/2006
Last updated: 26/06/2006
EMEA/CHMP/149558/2006 -
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Standard operating procedure for rapporteur / co-rapporteur appointment for re-examination of a CHMP opinion (PDF/104.49 KB)
Adopted
First published: 05/12/2008
Last updated: 26/09/2012
Legal effective date: 25/09/2012
SOP/H/3175 -
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Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products (PDF/131.14 KB)
Adopted
First published: 24/01/2007
Last updated: 06/05/2013
EMA/599941/2012 -
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Overview of comments received on the reflection paper on publication of CHMP negative opinion and refusal of marketing authorisation applications for human medicinal products (PDF/64.73 KB)
First published: 24/01/2007
Last updated: 24/01/2007
EMEA/482219/2006
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Reflection paper on European public assessment report summary for the public (PDF/47.31 KB)
Adopted
First published: 26/01/2006
Last updated: 26/01/2006
EMEA/126757/2005 -
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Overview of comments received on reflection paper - EPAR summary for the public (PDF/86.01 KB)
First published: 26/01/2006
Last updated: 26/01/2006
EMEA/20722/2006 -
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Principles to be applied for the deletion of commercially confidential information for the disclosure of EMEA documents (PDF/53.9 KB)
Adopted
First published: 15/04/2007
Last updated: 15/04/2007
EMEA/45422/2006 -
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Standard operating procedure for preparation of a European public assessment report for a human medicinal product following positive or negative opinion (PDF/121.26 KB)
Adopted
First published: 05/12/2007
Last updated: 13/09/2012
Legal effective date: 12/09/2012
SOP/H/3003 -
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Standard operating procedure for preparation and updates of European public assessment report summaries by Product-related Information to the Network Service (PDF/260.73 KB)
Adopted
First published: 24/09/2010
Last updated: 14/05/2014
Legal effective date: 28/03/2014
SOP/H/3131