Veterinary medicinal products for fluid therapy in case of diarrhoea - Scientific guideline

This document to provides specific guidance in respect of the documentation of the efficacy of new veterinary medicinal products suitable for fluid therapy to influence concurrent diarrhoea.

Keywords: Fluid therapy, diarrhoea, target animal, clinical trial, veterinary medicinal product (VMP)

Current effective version

Veterinary medicinal products for fluid therapy in case of diarrhoea

Adopted Reference Number: 7AE14a Volume 7 Legal effective date: 01/09/1992

Document history

Concept paper for the revision of the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea

Draft: consultation closed Consultation dates: 16/12/2016 to 31/03/2017 Reference Number: EMA/CVMP/EWP/707299/2015 Summary:

The guideline on veterinary medicinal products for fluid therapy in case of diarrhoea (7AE14a) was adopted in March 1992 and has been in force since September 1992. Following the review of current CVMP guidelines outlined in the ‘review and update of European Medicines Agency guideline to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (EMA/CHMP/CVMP/JEG-3Rs/704685/2012), an issue for review was noted in the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea (7AE14a; 1992) with regards to the 3Rs’ principles. Besides this issue, several other points were noted.