Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle

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Document details

Download document Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle
Reference number CVMP/344/1999 Rev. 2
Status draft: consultation open
First published 26/02/2016
Last updated 26/02/2016
Consultation start date 26/02/2016
Consultation end date 31/05/2016
Email address for submissions vet-guidelines@ema.europa.eu

Summary

This revised guideline is intended to provide guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle. It therefore addresses the treatment of clinical and subclinical mastitis during the lactation period, the treatment of subclinical mastitis at drying off, and the prevention of new intramammary infections during the dry period.