Superseded pharmacovigilance guidance documents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Volume 9A of the rules governing medicinal products in the European Union has been superseded by GVP.

Compliance with pharmacovigilance regulatory obligations

Concept paper on compliance with pharmacovigilance regulatory obligations

Adopted Reference Number: CPMP/PhVWP/1618/01 Legal effective date: 01/01/2002

Conduct of pharmacovigilance for vaccines

Guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases

Adopted Reference Number: EMEA/CHMP/PhVWP/503449/2007 Legal effective date: 01/10/2009

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)

Reference Number: EMEA/CHMP/PhVWP/36043/2009

Draft guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases

Draft: consultation closed Reference Number: EMEA/CHMP/PhVWP/503449/2007

Concept paper for a guideline on the conduct of pharmacovigilance for vaccines

Reference Number: EMEA/CHMP/PhVWP/372004/2005

CHMP guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data

Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data

Adopted Reference Number: EMEA/CHMP/313666/2005 Legal effective date: 02/05/2006

Conduct of pharmacovigilance for medicines used by paediatric population

Guideline on conduct of pharmacovigilance for medicines used by the paediatric population

Reference Number: EMEA/CHMP/PhVWP/235910/2005 Rev.1 Legal effective date: 26/01/2007