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
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).
English (EN) (311.71 KB - PDF)
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
English (EN) (276.71 KB - PDF)
Document history - Revision 1
Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1
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).
English (EN) (311.71 KB - PDF)
Overview of comments received on Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1
English (EN) (211.83 KB - PDF)
Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1
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.
English (EN) (193.4 KB - PDF)
Document history
Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products
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.
English (EN) (118.27 KB - PDF)
Draft revised guideline on the SPC for antimicrobial products
English (EN) (54.91 KB - PDF)
Overview of comments received on draft revised guideline on the SPC for antimicrobial products
English (EN) (56.87 KB - PDF)
Question and answer on the CVMP guideline on the summary of product characteristics for antimicrobial products
English (EN) (92.41 KB - PDF)