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.

Keywords: availability, limited market, classification, Article 4, Article 8, Annex II, Regulation (EU) 2019/6, non-biological veterinary medicinal products, quality, data requirements

Current version

Guideline on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets

Draft: consultation closed Consultation dates: 21/07/2023 to 31/01/2024 Reference Number: EMA/CVMP/QWP/47285/2022

Overview of comments received on 'Guideline on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets' (EMA/CVMP/QWP/47285/2022)

Reference Number: EMA/CVMP/QWP/50888/2024

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 quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market

Adopted Reference Number: EMA/CVMP/QWP/128710/2004-Rev.1 Legal effective date: 01/07/2017

Overview of comments received on ‘Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market’

Reference Number: EMA/CVMP/QWP/472725/2016

Draft guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market

Draft: consultation closed Consultation dates: 03/02/2016 to 31/07/2016 Reference Number: EMA/CVMP/QWP/128710/2004 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.

Note regarding CVMP guidelines on data requirements for veterinary medicinal products intended for minor uses or minor species - Revision 1

Adopted Reference Number: EMEA/CVMP/133672/2005-Rev.1 Legal effective date: 01/02/2007

Guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species

Adopted Reference Number: EMEA/CVMP/QWP/128710/2004 Legal effective date: 01/02/2007

Overview of comments received on guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species

Reference Number: EMEA/CVMP/QWP/50314/2006