Pharmacovigilance guidance

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This section contains complementary guidance to the rules included in Volume 9B - Pharmacovigilance for Medicinal Products for Veterinary Use.

 

Table of contents


Surveillance of EudraVigilance Veterinary data

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Periodic safety update reports (PSURs) of veterinary medicinal products

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Adverse event reporting

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Document(s) Language Status First published Last updated Effective Date
Draft reflection paper on non-spontaneous adverse event reports (peer-reviewed literature, internet and social media) (English only) draft: consultation open 27/05/2016    
Reflection paper on promotion of pharmacovigilance reporting (English only) adopted 20/03/2015    
Questions and answers on serious non-fatal adverse events and reporting rules (English only)   19/04/2013    
Questions and answers on adverse-event reporting (English only)   19/04/2013 18/12/2015  

A simple guide to reporting adverse reactions

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Document(s) Language Status First published Last updated Effective Date
Veterinary pharmacovigilance in the EU - A simple guide to reporting adverse reactions (English only) adopted 26/06/2006   01/01/2007
Concept paper for a simple guide to veterinary pharmacovigilance in the EU (English only)   16/06/2004    

Pharmacovigilance communication

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Triggering pharmacovigilance investigations

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Document(s) Language Status First published Last updated Effective Date
Guideline on a strategy for triggering pharmacovigilance investigations preceding regulatory actions by EU competent authorities (English only) adopted 13/04/2005   01/11/2005

Causality assessment

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Question and answer documents

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on how to express the frequency of adverse reactions within the product information (English only)   25/07/2016    
Questions and answers related to management and assessment of periodic safety update reports (PSURs) (English only)   05/08/2009 19/04/2013  
Questions and answers on serious non-fatal adverse events and reporting rules (English only)   19/04/2013    
Questions and answers on adverse-event reporting (English only)   19/04/2013 18/12/2015  

Historic guidance

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