Data requirements for immunological veterinary medicinal products intended for minor use or minor species - Scientific guideline

This document defined acceptable data requirements for the demonstration of quality, safety and efficacy for immunological veterinary medicinal products (IVMPs) intended for minor use. It applied to new applications for authorisation, line extensions and variations of IVMPs, defined as minor use immunological veterinary medicinal products.

It was superseded by the following guideline on 28 January 2022:

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

Keywords: Immunological veterinary medicinal products (IVMPs), minor use, minor species, limited markets

Document history - Revision 3

Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 3

AdoptedLegal effective date: 01/11/2017Reference Number: EMA/CVMP/IWP/123243/2006 Rev.3

Overview of comments received on 'Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market' (EMA/CVMP/IWP/123243/2006-Rev.3) - Revision ...

AdoptedLegal effective date: 01/11/2017Reference Number: EMA/CVMP/IWP/506137/2016

Draft guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 3

Consultation dates: 03/02/2016 to 31/07/2016Draft: consultation closedReference Number: EMA/CVMP/IWP/123243/2006 Rev.3Summary:

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.

Document history - Revision 2

Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species/limited markets - Revision 2

AdoptedLegal effective date: 01/05/2010Reference Number: EMA/CVMP/IWP/123243/2006-Rev.2

Overview of comments received on draft guideline on data requirements for IVMPS intended for minor use or minor species/limited markets - Revision 2

Reference Number: EMEA/CVMP/IWP/279839/2007

Draft guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species/limited markets - Revision 2

Draft: consultation closedReference Number: EMEA/CVMP/IWP/123243/2006-Rev.2

Document history - Revision 1

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

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

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

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