Veterinary medicinal products for zootechnical purposes - Scientific guideline

This guideline provides specific guidance in respect to the data requirements for efficacy and target animal safety of veterinary medicinal products for zootechnical purposes.

Keywords: Zootechnical product, target animal safety (TAS), oestrus synchronization, veterinary medicinal product (VMP)

Current effective version

Guideline on data requirements for veterinary medicinal products for zootechnical purposes

Adopted Reference Number: EMA/CVMP/EWP/37280/2023 Legal effective date: 01/08/2025

Revision 1

Draft guideline on data requirements for veterinary medicinal products for zootechnical purposes - Revision 1

Draft: consultation closed Consultation dates: 26/01/2024 to 31/05/2024 Reference Number: EMA/CVMP/EWP/37280/2023 Summary:

This guideline replaces the Guideline for veterinary medicinal products for zootechnical purposes (7AE7a)

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

Concept paper on the revision of the guideline for veterinary medicinal products for zootechnical purposes - Revision 1

Draft: consultation closed Consultation dates: 22/07/2022 to 31/10/2022 Reference Number: EMA/CVMP/EWP/222080/2022

Overview of comments received on 'Guideline on data requirements for veterinary medicinal products for zootechnical purposes' (EMA/CVMP/EWP/37280/2023)

Reference Number: EMA/CVMP/EWP/259888/2024

First version

Guideline on veterinary medicinal products for zootechnical purposes - First version

Adopted Reference Number: 7AE7a Volume 7 Legal effective date: 01/09/1992