Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6

This guideline defines the acceptable data requirements on efficacy and target animal safety for marketing authorisation applications for non-immunological veterinary medicines intended for veterinary limited markets under Article 23 of the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation became applicable on 28 January 2022.

This guideline replaced the Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (EMA/CVMP/EWP/117899/2004 Rev.1). 
 

Keywords: availability, limited market, classification, Article 23, Article 24, eligibility, Regulation 2019/6, non-immunological veterinary medicinal products, efficacy, target animal safety, data requirements

Guideline

Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6

AdoptedLegal effective date: 28/01/2022Reference Number: EMA/CVMP/52665/2020

Document history

Draft guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6

Consultation dates: 25/02/2021 to 15/05/2021Draft: consultation closedReference Number: EMA/CVMP/52665/2020Summary:

This draft guideline defines the acceptable data requirements on efficacy and target animal safety for marketing authorisation applications for non-immunological veterinary medicines intended for veterinary limited markets under Article 23 of the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation becomes applicable on 28 January 2022.

This guideline will replace the Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (EMA/CVMP/EWP/117899/2004 Rev.1). 

Overview of comments received on 'Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6

Reference Number: EMA/CVMP/147926/2021