User safety for pharmaceutical veterinary medicinal products - Scientific guideline

Veterinary Scientific guidelines

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

Adopted Reference Number: EMA/CVMP/543/03-Rev.1 Legal effective date:

English (EN) (193.81 KB - PDF)

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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 closed Consultation dates: to Reference Number: EMA/CVMP/SWP/564774/2023 Summary:

Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu 

English (EN) (198.42 KB - PDF)

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Document history - Revision 1

Guideline on user safety for pharmaceutical veterinary medicinal products

Adopted Reference Number: EMA/CVMP/543/03-Rev.1 Legal effective date:

English (EN) (193.81 KB - PDF)

First published: Last updated:
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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

English (EN) (89.38 KB - PDF)

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Revised guideline on user safety for pharmaceutical veterinary medicinal products

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

English (EN) (116.37 KB - PDF)

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

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

English (EN) (42.97 KB - PDF)

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Document history - First version

Guideline on user safety for pharmaceutical veterinary medicinal products

Adopted Reference Number: EMEA/CVMP/543/03-FINAL Legal effective date:

English (EN) (125.01 KB - PDF)

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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

English (EN) (151.28 KB - PDF)

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