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

Current version

PDF iconAdopted 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

PDF iconDraft reflection paper

In operation: 11/05/2017 - present

Published: 23/05/2017

Published: 27/05/2016

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