Union Product Database

The Union Product Database (UPD) contains information on all veterinary medicinal products for which a marketing authorisation has been issued by the Commission and by the competent authorities in the Union.

Access to the UPD

You can access the UPD here. In addition to the UPD, the Veterinary Medicinal Products Information Bank also contains information on all veterinary medicinal products permitted in the Netherlands.

Access to the UPD

Marketing authorisation holders have full access to the data held in the veterinary medicinal products database vis-à-vis their own marketing authorisations. That way, they have self-service access and can make changes themselves where no assessment is required (VNRA).

The competent authorities, the European Medicines Agency (EMA) and the European Commission have full access to all data held in the veterinary medicinal products database.

Moreover, anyone with an interest in veterinary medicinal products will have access to some data in the veterinary medicinal products database:

  • the list of veterinary medicinal products
  • the summaries of product characteristics
  • the package leaflets
  • the Public Assessment Reports (PuArs).

It is possible to:

  • search for and view information on all veterinary medicinal products permitted in the EU, irrespective of route of entry
  • search for Member States in which a specific veterinary medicinal product is available
  • consider possible treatment alternatives.

View further information on the UDP access policy.

Uploading data to the UPD

The guidelines for marketing authorisation holders and government bodies for uploading data to the Union Product Database are set out in the implementation guide. The implementation guide deals with issues such as the process, the timelines, the requirements, the technical specifications and the rules for submitting data.

The UPD uses the four SPOR data management services for the purposes of centralised management of master data in the EU. For further information, please see the Substance, product, organisation and referential (SPOR) master data.

Description of the requisite information

Marketing authorisation holders are required to upload the following information to the UPD for each veterinary medicinal product. You must do so for each form of packaging:

  • sales data
  • availability status.

The UPD is not intended for dossier storage. Marketing authorisation holders only need to upload a change file for those changes not requiring an assessment (VNRA). This has to be done in accordance with the VNeeS structure. This file is available in the UPD for a limited time (provisionally one year). Thereafter, these file sections will be put in storage.

Changes requiring an assessment (VRA) and new applications should be submitted and processed in the usual way. To this end, please see the information under submit dossier.

The competent authorities will upload the final version of the SPC, label and package leaflet and the Public Assessment Reports.

Further information on the UPD

The EMA’s website (here) features plenty of information on the UPD. Article 55 of the Veterinary Medicinal Products Regulation sets out the requirements for the UPD.