Three new databases for greater transparency on veterinary medicinal products in Europe

The new Regulation (EU) No 2019/6 on veterinary medicinal products provides for the creation of three databases, designed to improve access to and sharing of information on these products. Here is an overview of their objectives.

The European Union's product database

The Union Product Database holds information on all the veterinary medicinal products authorised in the European Union by the European Commission and the competent authorities of the Member States. For each one, it provides access to the summary of product characteristics, package leaflet and summary of the marketing authorisation assessment report.

The database was developed by the European Medicines Agency (EMA) in close cooperation with Member States. The French Agency for Veterinary Medicinal Products (ANMV), a part of ANSES, chaired the group of experts that formulated the opinion for preparing the implementing regulation establishing the database's functions, and co-chaired the group tasked with monitoring the IT project for three years.

The European Union's pharmacovigilance database

EudraVigilance Veterinary has been designed to receive all reports of suspected adverse events occurring in animals following the use of medicinal products authorised in veterinary or human medicine, or in humans following the use of veterinary medicinal products.

It makes pharmacovigilance information, including the number of suspected adverse events, publicly available. Within the next two years, new features will be developed to provide access to data on the incidence of adverse events, as well as to the results and conclusions of the report management process, which will analyse the emergence of unusual adverse events.

The ANMV took part in the user working group that provided technical expertise to the IT developers and participated in testing before the database went online.

The database of manufacturers and wholesale distributors

EudraGMDP lists manufacturers and wholesale distributors of veterinary medicinal products. It offers transparency of information on manufacturers, wholesale distributors and importers of veterinary medicinal products, as well as on their good manufacturing practice certificates. Most of the legislative requirements set out in Regulation (EU) No 2019/6 were already covered by the previous version of the EudraGMDP system. However, the new database includes additional information, such as authorisations for wholesale distribution of veterinary medicines.

This database interconnects with the other systems under the control of the EMA: the two new databases mentioned above, and also the system of standards developed by the EMA. The ANMV took part in the project to develop this database as the representative of France.