Superseded pharmacovigilance guidance documents

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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Volume 9A of the rules governing medicinal products in the European Union has been superseded by GVP. Where GVP modules have not yet been finalised, and for some transitionary measures, the relevant parts of volume 9A remain the reference.

Table of contents


Compliance with pharmacovigilance regulatory obligations

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Document(s) Language Status First published Last updated Effective Date
Concept paper on compliance with pharmacovigilance regulatory obligations (English only) adopted 2001-11-15   2002-01-01

Conduct of pharmacovigilance for vaccines

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