Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Scientific guideline

This document defined the acceptable data requirements for safety and residues documentation for veterinary medicinal products intended for minor uses or minor species.

It was superseded by the following guideline on 28 January 2022:

• Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline

Keywords: Minor uses/minor species (MUMS), data requirements

Current version

Adopted guideline on safety and residue data requirements for the establishment of Maximum Residue Limits in minor species

Adopted Reference Number: EMA/CVMP/345236/2020 Legal effective date: 01/10/2022

Overview of comments received on ‘Guideline on safety and residue data requirements for the establishment of Maximum Residue Limits in minor species’ (EMA/CVMP/345236/2020)

Reference Number: EMA/CVMP/148042/2021

Document history - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft: consultation closed Consultation dates: 18/12/2018 to 31/08/2019 Reference Number: EMA/CVMP/SWP/66781/2005 Rev. 2 Summary:

This guideline updates the CVMP Guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species/ limited market  (EMEA/CVMP/SWP/66781/2005 Rev. 1).

In order to stimulate the research, development and innovation 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. These guidelines are intended to reduce data requirements where possible for products classified as MUMS/limited market while still providing assurance of appropriate quality, safety and efficacy and complying with the legislation in place and leading to an overall positive benefit-risk balance for the product.

Overview of comments received on “Revised guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market” EMA/CVMP/SWP/66781/2005–Rev.2

Reference Number: EMA/CVMP/57188/2020

Concept paper for the revision of the guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market

Draft: consultation closed Consultation dates: 26/01/2018 to 28/02/2018 Reference Number: EMA/CVMP/SWP/779037/2017 Summary:

In order to stimulate the development of veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP has developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals, as well as a guideline for immunologicals. The guideline that focuses on safety requirements for pharmaceuticals includes a section on extrapolation of maximum residue limits (MRLs) from major to minor species.

Document history - Revision 1

Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market

Adopted Reference Number: EMA/CVMP/SWP/66781/2005–Rev.1 Legal effective date: 01/07/2017

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

Reference Number: EMA/CVMP/SWP/523387/2016

Draft guideline on safety and residue 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/66781/2005 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 safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species

Adopted Reference Number: EMEA/CVMP/SWP/66781/2005 Legal effective date: 01/02/2007

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

Reference Number: EMEA/CVMP/SWP/401874/2005

Superseded document

Note for guidance on the establishment of maximum residue limits for minor animal species

Adopted Reference Number: EMEA/CVMP/153a/97-FINAL Legal effective date: 12/09/1997