Dossier requirements for anticancer medicinal products for dogs and cats - Scientific guideline
VeterinaryScientific guidelines
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
AdoptedReference Number: EMA/CVMP/28510/2008 Rev.1Legal effective date:
English (EN) (425.33 KB - PDF)
First published:
Document history
Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats
Draft: consultation closedConsultation dates:
to Reference Number: EMA/CVMP/EWP/259765/2024Summary:
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (173.33 KB - PDF)
First published:
Guideline on dossier requirements for anticancer medicinal products for dogs and cats
AdoptedReference Number: EMEA/CVMP/28510/2008Legal effective date:
English (EN) (224.61 KB - PDF)
First published: Last updated:
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
English (EN) (182.36 KB - PDF)
First published: Last updated:
Draft guideline on dossier requirements for anticancer medicinal products for dogs and cats (consultation)
Draft: consultation closedReference Number: MEA/CVMP/28510/2008-CONSULTATION
English (EN) (198.82 KB - PDF)
First published: Last updated:
Concept paper on dossier requirements for oncology products
Reference Number: EMEA/CVMP/EWP/79590/2005
English (EN) (33.43 KB - PDF)
First published: Last updated:
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English (EN) (179.52 KB - PDF)
First published: