Non-spontaneous adverse event reports (literature, internet and social media) for veterinary medicinal products

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Current version

Adopted reflection paper

Reference numberEMA/CVMP/PhVWP/357539/2015
Published23/05/2017
Keywordsveterinary pharmacovigilance, non-spontaneous adverse events, literature
DescriptionThis reflection paper aims to examine the current situation on obtaining pharmacovigilance information from non-spontaneous sources (literature, internet and social media) as a basis for the development of future guidance. Non-spontaneous reports from studies (e.g. post-authorisation safety studies and clinical trials etc.) are excluded from the scope of this document. It is acknowledged that the scope of topics covered by this paper is broad and diverse, but this reflects the nature of pharmacovigilance reports from informal sources such as the internet.


Document history

First version

Current version

Adopted reflection paper
 

Overview of comments
 

Draft reflection paper

In operation: 11/05/2017 - present
 

Published: 23/05/2017
 

Published: 27/05/2016

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