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

This guideline defines the acceptable data requirements on safety and residues for marketing authorisation applications for non-immunological veterinary medicines intended for veterinary limited markets under Article 23 the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation became applicable on 28 January 2022.

This guideline replaced the Guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005 Rev.2).
 

Keywords: availability, limited market, classification, Article 23, Article 24, eligibility, Regulation 2019/6, minor species, safety data, residue data, veterinary medicinal products

Guideline

Guideline on 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

AdoptedLegal effective date: 28/01/2022Reference Number: EMA/CVMP/345237/2020

Document history

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

Consultation dates: 25/02/2021 to 15/05/2021Draft: consultation closedReference Number: EMA/CVMP/345237/2020Summary:

This draft guideline defines the acceptable data requirements on safety and residues for marketing authorisation applications for non-immunological veterinary medicines intended for veterinary limited markets under Article 23 the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation becomes applicable on 28 January 2022.

This guideline will replace the Guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005 Rev.2).

Overview of comments received on 'Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation(EU) 2019/6 (EMA/CVMP/345237)

Reference Number: EMA/CVMP/148001/2021