Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances
| Current effective version | |
| Reference number | EMA/CVMP/627/2001 Rev. 1 |
| Published | 03/02/2016 |
| Effective from | 01/08/2016 |
| Keywords | Antimicrobial, pharmacokinetic/pharmacodynamic (PK/PD) relationship, clinical study, summary of product characteristics (SPC), veterinary medicinal product (VMP) |
| Description | This 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 | (second consultation) | 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 |
 Adopted guideline
| In operation: 11/06/2003–01/08/2016 |
Related content
- Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics
- Focus group meeting on the revision of the CVMP guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (09/12/2013)
- Directive 2001/82/EC
-
Summary of product characteristics for veterinary medicinal products containing antimicrobial substances
-
Question and answer on the CVMP guideline on the SPC for antimicrobial products
-
Use of fluoroquinolones in food producing animals - precautions for use in the SPC regarding prudent use guidance
- Directive 2010/63/EC
- Good Laboratory Practice
- Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals conduct of efficacy studies for intramammary products for use in cattle
- Conduct of pharmacokinetic studies in target animal species
- Fixed combination products
- Statistical principles for veterinary clinical trials
- VICH GL9 Good clinical practices
- VICH GL27 Guidance on the pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance