User safety of topically administered products - Scientific guideline

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Keywords: antimicrobial, summary of product characteristics, SPC, veterinary medicinal products, responsible use, resistance, susceptibility testing, breakpoints

Current effective version - Currently under revision see concept paper below

Guideline on user safety of topically administered veterinary medicinal products

AdoptedReference Number: EMA/CVMP/SWP/721059/2014

Revsion 1

Concept paper on the revision of the Guideline on user safety of topically administered veterinary medicinal products (EMA/CVMP/SWP/721059/2014)

Draft: consultation closedConsultation dates: 15/09/2023 to 30/11/2023Reference Number: EMA/CVMP/SWP/104211/2023Summary:

The proposed guideline will revise and replace 'Guideline on user safety of topically administered veterinary medicinal products’ (EMA/CVMP/SWP/721059/2014)

Keywords: user safety, topically administered veterinary medicinal products

Document history

Guideline on user safety of topically administered veterinary medicinal products

AdoptedReference Number: EMA/CVMP/SWP/721059/2014

Overview of comments received on 'Guideline on user safety of topically administered veterinary medicinal products'

Reference Number: EMA/CVMP/SWP/30675/2017

Draft guideline on user safety of topically administered veterinary medicinal products

Draft: consultation closedConsultation dates: 27/06/2016 to 31/12/2016Reference Number: EMA/CVMP/SWP/721059/2014Summary:

The guideline on user safety of topically administered products has been written to provide specific

guidance and advice on how user risk assessments should be conducted for such products.

Draft concept paper for a guideline on user safety of topically administered products

Draft: consultation closedConsultation dates: 24/03/2014 to 30/06/2014Reference Number: EMA/CVMP/SWP/92311/2014Summary:

This concept paper addresses the need for a specific user safety guideline for topically administered products. The CVMP adopted the revised general User Safety Guideline for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1) in March 2010. This document provides general guidance on how user risk assessment should be conducted and reported. It does not provide specific guidance on how exposure from topically administered products should be assessed.