Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CVMP/627/2001 Rev. 1
Effective from01/08/2016
KeywordsAntimicrobial, pharmacokinetic/pharmacodynamic (PK/PD) relationship, clinical study, summary of product characteristics (SPC), veterinary medicinal product (VMP)
DescriptionThis document provide guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals.

Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments

(second consultation)


PDF iconRevised draft guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/08/2016


Published: 03/02/2016


Published: 04/03/2015


Published: 04/03/2015


Published: 29/05/2013


Published: 20/04/2011

First version PDF iconAdopted guideline In operation: 11/06/2003–01/08/2016

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