Quality data requirements for applications for biological veterinary medicinal products intended for limited markets - Scientific guideline

Table of contents

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

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