Dossier requirements for anticancer medicinal products for dogs and cats - Scientific guideline

This document outlines the conditions and data requirements for the demonstration of quality, safety (user, target animal), efficacy and environmental impact of anticancer veterinary medicinal product used in dogs and cats.

Keywords: Veterinary medicinal product, medicine, dog, cat, oncology, anti-cancer drug.

Current version (currently under revision)

Guideline on dossier requirements for anticancer medicinal products for dogs and cats - Revision 1

Adopted Reference Number: EMA/CVMP/28510/2008 Rev.1 Legal effective date: 28/01/2022

Document history

Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats

Draft: consultation closed Consultation dates: 26/07/2024 to 31/10/2024 Reference Number: EMA/CVMP/EWP/259765/2024 Summary:

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

Guideline on dossier requirements for anticancer medicinal products for dogs and cats

Adopted Reference Number: EMEA/CVMP/28510/2008 Legal effective date: 01/11/2009

Overview of comments received on draft guideline on dossier requirements for anticancer medicinal products for dogs and cats (EMEA/CVMP/28510/2008-consultation)

Reference Number: EMEA/CVMP/512902/2008

Draft guideline on dossier requirements for anticancer medicinal products for dogs and cats (consultation)

Draft: consultation closed Reference Number: MEA/CVMP/28510/2008-CONSULTATION

Concept paper on dossier requirements for oncology products

Reference Number: EMEA/CVMP/EWP/79590/2005