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
-
List item
Guideline on user safety of topically administered veterinary medicinal products (PDF/394.18 KB)
Adopted
First published: 07/05/2018
Last updated: 07/05/2018
EMA/CVMP/SWP/721059/2014 -
List item
Overview of comments received on 'Guideline on user safety of topically administered veterinary medicinal products' (PDF/358.31 KB)
First published: 07/05/2018
Last updated: 07/05/2018
EMA/CVMP/SWP/30675/2017 -
List item
Draft guideline on user safety of topically administered veterinary medicinal products (PDF/241.86 KB)
Draft: consultation closed
First published: 27/06/2016
Last updated: 27/06/2016
Consultation dates: 27/06/2016 to 31/12/2016
EMA/CVMP/SWP/721059/2014 -
List item
Draft concept paper for a guideline on user safety of topically administered products (PDF/84.35 KB)
Draft: consultation closed
First published: 24/03/2014
Last updated: 24/03/2014
Consultation dates: 24/03/2014 to 30/06/2014
EMA/CVMP/SWP/92311/2014