User safety for immunological veterinary medicinal products - Scientific guideline

This document provides guidance and advice on user safety risk assessments. It applies to new applications and renewals of marketing authorisation for immunological veterinary medicinal products and does not require the generation of specific or additional data.

Keywords: User safety, hazard identification and characterisation, exposure assessment risk characterisation, risk management, risk communication

Current effective version

Guideline on user safety for immunological veterinary medicinal products

Adopted Reference Number: EMEA/CVMP/IWP/54533/2006 Legal effective date: 01/11/2007

Document history

Overview of comments received on draft guideline on user safety for immunological veterinary medicinal products

Reference Number: EMEA/145621/2007