Safety and efficacy data requirements for applications for immunological VMPs intended for limited markets but not eligible for authorisation under Art 23 of Reg (EU) 2019-6 - Scientific guideline
Table of contents
The aim of this guidance is to define acceptable data requirements for the demonstration of safety and efficacy of immunological veterinary medicinal products (IVMPs) classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6 but not eligible for authorisation under Article 23 of same Regulation.
Keywords: Availability, limited market, Article 4, Article 8, Article 23, Regulation (EU) 2019/6, safety and efficacy data requirements for immunological veterinary medicinal products