User safety of topically administered products

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Current version

Draft guideline

Currently under revision - see below

Reference numberEMA/CVMP/SWP/721059/2014
Keywordsantimicrobial, summary of product characteristics, SPC, veterinary medicinal products, responsible use, resistance, susceptibility testing, breakpoints
DescriptionThe 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.

Document history

First version
In progress

Adopted guideline


Overview of comments

Draft guideline


Concept paper

Published: 07/05/2018
Effective from: 01/11/2018

Published: 07/05/2018


Published: 27/06/2016
Deadline for comments: 31/12/2016

Published: 14/04/2005

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