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

VeterinaryRegulatory and procedural guidanceVeterinary limited marketsScientific guidelines

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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: to Reference Number: EMA/CVMP/435071/2021

English (EN) (190.83 KB - PDF)

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