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

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

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

Document history

Concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6

Consultation dates: 15/10/2021 to 15/12/2021Draft: consultation closedReference Number: EMA/CVMP/435071/2021