The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6 (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, and the limited time in which all work needs to be completed, transition to the new QRD template is a major issue at present. In this article we present the key aspects that the revision entails for the years ahead, as this is one of the main challenges for applicants and competent authorities alike.
Five great reasons to become a TOPRA member:
Have you heard what you’re missing? Listen now to the RegRapPod podcast show, for free!