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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, Article 23, Annex II, Regulation (EU) 2019/6, non-biological veterinary medicinal products, quality, data requirements
Current version
Draft guideline on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets
English (EN) (317.39 KB - PDF)
Document history
Concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6
English (EN) (190.83 KB - PDF)
Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
English (EN) (302.05 KB - PDF)
Overview of comments received on ‘Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market’
English (EN) (148.57 KB - PDF)
Draft guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
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.
English (EN) (165.86 KB - PDF)
Note regarding CVMP guidelines on data requirements for veterinary medicinal products intended for minor uses or minor species - Revision 1
English (EN) (41.66 KB - PDF)
Guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species
English (EN) (51.43 KB - PDF)
Overview of comments received on guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species
English (EN) (34.91 KB - PDF)