Conduct of efficacy studies for intramammary products for use in cattle - Scientific guideline

This document provides guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle.

Keywords: Intramammary preparations, milk, udder, mastitis, somatic cell counts, veterinary medicinal product (VMP)

Current effective version

Guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 3

Adopted Consultation dates: 28/06/2024 to 31/10/2024 Reference Number: EMA/CVMP/344/1999 Rev.3* Summary:

This guideline provides guidance on design, conduct and reporting of pre-clinical studies and clinical trials or veterinary medicinal products for intramammary use in dairy cattle. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.

Comments should be provided using this template. The completed comments form should be sent to [e-mail].

Revision 3

Guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 3

Adopted Consultation dates: 28/06/2024 to 31/10/2024 Reference Number: EMA/CVMP/344/1999 Rev.3* Summary:

This guideline provides guidance on design, conduct and reporting of pre-clinical studies and clinical trials or veterinary medicinal products for intramammary use in dairy cattle. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.

Comments should be provided using this template. The completed comments form should be sent to [e-mail].

Overview of comments received on ‘Guideline on the conduct of efficacy studies for intramammary products for use in cattle’ (EMA/CVMP/344/1999/Rev.3)

Reference Number: EMA/CVMP/EWP/497046/2024

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

Draft: consultation closed Reference Number: EMA/CVMP/344/1999-Rev.3*

Revision 2

Guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 2

Adopted Reference Number: EMA/CVMP/344/1999-Rev.2 Legal effective date: 01/08/2017

Overview of comments received on Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 2 (second version)

Reference Number: EMA/CVMP/EWP/444475/2016

Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 2 (second version)

Draft: consultation closed Consultation dates: 26/02/2016 to 31/05/2016 Reference Number: CVMP/344/1999 Rev. 2 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.

Overview of comments received on Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 2 (first verison)

Reference Number: EMA/CVMP/EWP/335976/2014

Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 2 (first verison)

Draft: consultation closed Consultation dates: 18/10/2013 to 30/04/2014 Reference Number: EMEA/CVMP/EWP/141272/2011 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. The scope of the guideline has been extended in order to include recommendations on preclinical data, in addition to those on clinical field studies for the demonstration of efficacy. Moreover, information is included for generic intramammary products.

Concept paper for the revision of the guideline on the conduct of efficacy studies for intramammary products for use in cattle

Draft: consultation closed Consultation dates: 15/09/2010 to 31/12/2010 Reference Number: EMA/CVMP/EWP/87114/2010

Revision 1

Guideline for the conduct of efficacy studies for intramammary products for use in cattle - Revision 1

Adopted Reference Number: EMEA/CVMP/344/99-Rev.1 Legal effective date: 08/09/2000