Quality data requirements for applications for biological veterinary medicinal products intended for limited markets - Scientific guideline

The aim of this guidance is to define acceptable data requirements for the demonstration of the quality of biological veterinary medicinal products, including immunological veterinary medicinal (IVMPs) products, classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.

Keywords: Availability, limited market, Article 4, Article 8, Article 23, Regulation (EU) 2019/6, quality data requirements for biological veterinary medicinal products

Current version

Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets

Draft: consultation closed Consultation dates: 07/09/2023 to 31/01/2024 Reference Number: EMA/CVMP/IWP/228730/2022 Summary:

The aim of this guidance is to define acceptable data requirements for the demonstration of the quality of biological veterinary medicinal products, including immunological veterinary medicinal (IVMPs) products, classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.

Keywords: Availability, limited market, Article 4, Article 8, Article 23, Regulation (EU) 2019/6, quality data requirements for biological veterinary medicinal products

Overview of comments received on Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets (EMA/CVMP/IWP/228730/2022)

Reference Number: EMA/CVMP/IWP/53990/2024

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