User safety for pharmaceutical veterinary medicinal products

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMEA/CVMP/543/2003 Rev. 1
Published18/03/2010
Effective from01/10/2010
KeywordsUser safety
DescriptionThis document provides guidance and advice on user safety risk assessments. It applies to applications for marketing authorisations (MA) for pharmaceutical veterinary medicinal products. This also includes applications to vary the MA where there is an impact on user safety.


Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/10/2010–present


Published: 18/03/2010


Published: 20/04/2009


Published: 21/04/2008

First version

PDF iconAdopted guideline


PDF iconOverview of comments

In operation: 13/07/2005–01/10/2010


Published: 14/04/2005


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