Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Scientific guideline

This revised guideline on the SPC for antimicrobial products provides updated guidance for instructions on the information to be included in the Summary of Product Characteristics of the veterinary medicinal product containing antimicrobial substances.

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

Current effective version

Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1

Adopted Reference Number: EMA/CVMP/383441/2005-Rev.1 Corr1 Legal effective date: 28/01/2022 Summary:

This guideline replaces the current CVMP guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) and the Question 2 of the question & answer document (EMA/CVMP/414812/2011-Rev.2).

Questions and answers on the guideline on the SPC for VMPs containing antimicrobial substances – antibiotic clinical breakpoints that may be included in section 4.2 of the SPC for generic VMPs

Reference Number: EMA/CVMP/AWP/933465/2022 Corr.1

Document history - Revision 1

Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1

Adopted Reference Number: EMA/CVMP/383441/2005-Rev.1 Corr1 Legal effective date: 28/01/2022 Summary:

This guideline replaces the current CVMP guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) and the Question 2 of the question & answer document (EMA/CVMP/414812/2011-Rev.2).

Overview of comments received on Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1

Adopted Reference Number: EMA/CVMP/692904/2018

Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1

Draft: consultation closed Consultation dates: 30/04/2018 to 31/08/2019 Reference Number: EMA/CVMP/383441/2005-Rev.1 Summary:

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.

Document history

Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products

Draft: consultation closed Consultation dates: 25/07/2016 to 31/10/2016 Reference Number: EMA/CVMP/AWP/161553/2016 Summary:

The current guideline on the summary of product characteristics (SPC) for antimicrobial products was developed during 2001-2002 by the EWP and came into effect on 11 June 2003. The guideline was revised by SAGAM (now AWP) during 2006 and 2007 and the revised guideline came into effect on 1 May 2008 (EMEA/CVMP/SAGAM/383441/2005)(1). Since then there have been further significant developments in principles of antimicrobial therapy and antimicrobial resistance and various initiatives have been taken by CVMP.

Draft revised guideline on the SPC for antimicrobial products

Draft: consultation closed Reference Number: EMEA/CVMP/SAGAM/383441/2005-CONSULTATION

Overview of comments received on draft revised guideline on the SPC for antimicrobial products

Reference Number: EMEA/CVMP/SAGAM/420018/2007

Question and answer on the CVMP guideline on the summary of product characteristics for antimicrobial products

Reference Number: EMA/CVMP/414812/2011 Rev.2