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

Current effective version (currently under revision)

Guideline on user safety for pharmaceutical veterinary medicinal products

AdoptedReference Number: EMA/CVMP/543/03-Rev.1Legal effective date: 01/10/2010

Document history - Revision 2

Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)

Draft: consultation closedConsultation dates: 26/07/2024 to 31/10/2024Reference Number: EMA/CVMP/SWP/564774/2023Summary:

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Document history - Revision 1

Guideline on user safety for pharmaceutical veterinary medicinal products

AdoptedReference Number: EMA/CVMP/543/03-Rev.1Legal effective date: 01/10/2010

Overview of comments received on revised ‘Guideline on user safety for pharmaceutical veterinary medicinal products’ (EMEA/CVMP/543/03-Rev.1-CONSULTATION)

Reference Number: EMA/CVMP/SWP/662388/2009

Revised guideline on user safety for pharmaceutical veterinary medicinal products

Draft: consultation closedReference Number: EMEA/CVMP/543/03-Rev.1

Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products

Reference Number: EMEA/CVMP/SWP/173804/2008-CONS

Document history - First version

Guideline on user safety for pharmaceutical veterinary medicinal products

AdoptedReference Number: EMEA/CVMP/543/03-FINALLegal effective date: 13/07/2005

Overview of comments received on draft guideline on user safety for pharmaceutical veterinary medicinal products (EMEA/CVMP/543/03-CONSULTATION)

Reference Number: EMEA/CVMP/41180/2005-FINAL