Scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6

This concept paper is the first step of EMA providing further guidance on flexibility on data requirements for applicants whose product only meets the criterion on being intended for a limited market.

Keywords: availability, limited market, classification, Article 8, Article 23, eligibility, Regulation (EU) 2019/6, veterinary medicinal products

Concept paper

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