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 - Scientific guideline

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.

Keywords: availability, limited market, Article 4, Article 8, Article 23, eligibility, Regulation (EU) 2019/6, efficacy, target animal safety, data requirements

Current version

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

Adopted Consultation dates: 21/07/2023 to 31/01/2024 Reference Number: EMA/CVMP/EWP/231668/2022 Summary:

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.

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 but not eligible for authorisation under Article 23 of Reg

Document history

Concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6

Draft: consultation closed Consultation dates: 15/10/2021 to 15/12/2021 Reference Number: EMA/CVMP/435071/2021

Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/117899/2004–Rev.1

Overview of comments received on 'Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market'

Reference Number: EMA/CVMP/EWP/523421/2016

Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1

Draft: consultation closed Consultation dates: 03/02/2016 to 31/07/2016 Reference Number: EMA/CVMP/EWP/117899/2004 Rev.1 Summary:

In order to stimulate the development of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals and a guideline for immunologicals.

Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species

Adopted Reference Number: EMEA/CVMP/EWP/117899/2004 Legal effective date: 20/07/2006

Overview of comments received on draft guideline efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species

Reference Number: EMEA/CVMP/EWP/43872/2006

Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species

Draft: consultation closed Reference Number: EMEA/CVMP/EWP/117899/2004

Points to consider regarding efficacy requirements for minor species and minor indications

Reference Number: EMEA/CVMP/610/01-Consultation