EMA - Veterinary Scientific Guidance Update - Adopted and Draft Guidance

14th August 2024

EMA

View all here: www.ema.europa.eu/en/news-events/open-consultations 

New:

• Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats. Reference Number: EMA/CVMP/EWP/259765/2024. Status Draft Consultation end 31OCT2024.
• Concept paper on the revision of the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees. Reference Number: EMA/CVMP/EWP/247519/2024. Status Draft Consultation end 31OCT2024.
• Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products – Revision 4. Reference Number: EMA/CVMP/256158/2024. Status Draft Consultation end 31OCT2024.
• Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products – Revision 1.  Reference Number: EMA/CVMP/SWP/564774/2023. Status Draft Consultation end 31OCT2024.
• Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 2. Reference Number: EMA/CVMP/627/2001 Rev.2. Status Draft Consultation end 31OCT2024.

Awaiting finalization:

• Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Revision 1. Reference Number: EMA/CVMP/QWP/515653/2023.  Status Draft Consultation end: 31AUG2024

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