Safety and efficacy data requirements for applications for immunological VMPs intended for limited markets but not eligible for authorisation under Art 23 of Reg (EU) 2019-6 - Scientific guideline

The aim of this guidance is to define acceptable data requirements for the demonstration of safety and efficacy of immunological veterinary medicinal products (IVMPs) classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6 but not eligible for authorisation under Article 23 of same Regulation.

Keywords: Availability, limited market, Article 4, Article 8, Article 23, Regulation (EU) 2019/6, safety and efficacy data requirements for immunological veterinary medicinal products

Current version

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

Adopted Consultation dates: 15/09/2023 to 31/01/2024 Reference Number: EMA/CVMP/IWP/224724/2022

Overview of comments received on Guideline on safety and efficacy data requirements for applications immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EM

Reference Number: EMA/CVMP/IWP/53315/2024

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