EMA - Veterinary Papers Released for Public Consultation

16th November 2023

EMA

The European Medicines Agency has published for public consultation the following two papers:

Quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets - Scientific guideline
The guideline defines acceptable data requirements for the demonstration of quality of veterinary medicinal products other than biologicals classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.

Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6

This guideline clarifies the efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 31 January 2024.

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