This document provides detailed guidance on the data elements and associated business rules for the submission of information on medicinal products authorised for veterinary use into the Union Product Database (UPD), as required in Regulation (EU) 2019/6 and Commission Implementing
Regulation (EU) 2021/16.
The EU Implementation Guide (Vet EU IG) on veterinary medicines product data Chapter 2 describes the data fields and the business rules and specifications for the creation of a new veterinary medicinal product in the context of regulatory entitlements and the maintenance of veterinary medicinal products after 28 January 2022.
Annex 1 of this document describes the fields relevant for “common data”, also referred to as European data, and for “national data” for veterinary medicinal products authorised through the MRP/DCP and subsequent recognition procedures (Subsequent Recognition Procedures (SRP)).