User safety for pharmaceutical veterinary medicinal products - Scientific guideline
This 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.
Keywords: User safety
-
List item
Guideline on user safety for pharmaceutical veterinary medicinal products (PDF/193.81 KB)
Adopted
First published: 18/03/2010
Last updated: 18/03/2010
Legal effective date: 01/10/2010
EMA/CVMP/543/03-Rev.1 -
List item
Overview of comments received on revised ‘Guideline on user safety for pharmaceutical veterinary medicinal products’ (EMEA/CVMP/543/03-Rev.1-CONSULTATION) (PDF/89.38 KB)
First published: 18/03/2010
Last updated: 18/03/2010
EMA/CVMP/SWP/662388/2009 -
List item
Revised guideline on user safety for pharmaceutical veterinary medicinal products (PDF/116.37 KB)
Draft: consultation closed
First published: 20/04/2009
Last updated: 20/04/2009
EMEA/CVMP/543/03-Rev.1 -
List item
Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products (PDF/42.97 KB)
First published: 21/04/2008
Last updated: 21/04/2008
EMEA/CVMP/SWP/173804/2008-CONS
-
List item
Guideline on user safety for pharmaceutical veterinary medicinal products (PDF/125.01 KB)
Adopted
First published: 17/01/2005
Last updated: 17/01/2005
Legal effective date: 13/07/2005
EMEA/CVMP/543/03-FINAL -
List item
Overview of comments received on draft guideline on user safety for pharmaceutical veterinary medicinal products (EMEA/CVMP/543/03-CONSULTATION) (PDF/151.28 KB)
First published: 14/04/2005
Last updated: 14/04/2005
EMEA/CVMP/41180/2005-FINAL