Superseded pharmacovigilance guidance documents
This page lists the pharmacovigilance guidance documents that were applicable before the introduction of the guideline on good pharmacovigilance practices (GVP).
Volume 9A of the rules governing medicinal products in the European Union has been superseded by GVP.
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Guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases (PDF/202.27 KB)
Adopted
First published: 22/07/2009
Last updated: 22/07/2009
Legal effective date: 01/10/2009
EMEA/CHMP/PhVWP/503449/2007 -
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Overview of comments received on draft guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases (EMEA/CHMP/PHVWP/503449/2007) (PDF/136.51 KB)
First published: 22/07/2009
Last updated: 22/07/2009
EMEA/CHMP/PhVWP/36043/2009 -
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Draft guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases (PDF/300.39 KB)
Draft: consultation closed
First published: 25/09/2008
Last updated: 25/09/2008
EMEA/CHMP/PhVWP/503449/2007 -
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Concept paper for a guideline on the conduct of pharmacovigilance for vaccines (PDF/63.55 KB)
First published: 11/10/2005
Last updated: 11/10/2005
EMEA/CHMP/PhVWP/372004/2005