Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 - Scientific guideline

This guideline clarifies the safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Keywords: Availability, limited market, Article 4, Article 8, Article 23, eligibility, Regulation (EU) 2019/6, safety data, residue data

Current version

Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6

Draft: consultation closedConsultation dates: 15/09/2023 to 31/01/2024Reference Number: EMA/CVMP/SWP/32027/2022Summary:

This guideline clarifies the safety and residue  data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Keywords: Availability, limited market, Article 4, Article 8, Article 23, eligibility, Regulation (EU) 2019/6, safety data, residue data

Overview of comments received on Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 201

Reference Number: EMA/CVMP/SWP/46749/2024

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 closedConsultation dates: 15/10/2021 to 15/12/2021Reference Number: EMA/CVMP/435071/2021