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
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