Veterinary Scientific Guidance Update

28th March 2024

Veterinary Scientific Guidance Update

EMA Adopted and Draft Guidance
Open consultations | European Medicines Agency (europa.eu)

Updated:

• Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Annex on compatibility studies between veterinary medicinal products and biocidal products. Reference Number: EMA/CVMP/QWP/592906/2022. Status Adopted. Publish date: 08/03/2024

Awaiting finalisation:

• Draft guideline on VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products. Reference Number: EMA/CVMP/196216/2021. Status Draft Consultation end: 25MAR2024

This document provides guidance on good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) used in veterinary medicinal products. It provides an appropriate system for managing quality and, as such, is intended to help ensure that APIs meet quality and purity standards. It applies to APIs manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these.

• Draft guideline on live recombinant vector vaccines for veterinary use - Revision 1. Reference Number: EMA/CVMP/IWP/390313/2023.  Status Draft Consultation end: 31MAY2024

This guideline provides guidance on the data to be submitted in the marketing authorisation application for the veterinary live recombinant vector vaccines. 

• Draft guideline on data requirements for veterinary medicinal products for zootechnical purposes - Revision 1. Reference Number: EMA/CVMP/EWP/37280/2023. Status Draft Consultation end: 31MAY2024

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

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VICH Guidance

Concept Papers (vichsec.org)

• GMP for API: Good Manufacturing Practive for Active Pharmaceutical Ingredient used in Veterinary Medicinal Products. Reference: VICH GL60. Consultation end: March 2024
• Reproduction: Studies to evaluate the safety of residues of veterinary drug in human food: reproduction studies. Reference: VICH GL22 (R). Consultation end: 31JUL2024
• Pharmaceutical development: pharmaceutical development for veterinary medicinal products. Reference: VICH GL61. Consultation end: 15AUG2024
   

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