Union Product Database (UPD)
Since the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) entered into force, the active use of the UPD for variations not requiring assessment (VNRA) is obligatory for the applicant / marketing authorisation holder.
www.ema.europa.eu/en/veterinary-regulatory/overview/veterinary-medicines-regulation/union-product-database.
We continuously analyse occurring errors and send suggestions for correction to the EMA.
Please feel free to report your bugs and suggested fixes directly to the EMA:
UPD-User-access: servicedesk.ema.europa.eu/jira/servicedesk/customer/portal/283
Public UPD-access: www.medicinesinfo.eu/de
Further inquiry note
UPD contact point
If you notice missing products or unclear information in the UPD, please contact the UPD contact point upd-contact@ages.at. As long as not all products are available in the UPD, the 30 days after which a VNRA normally has to be entered in the UPD can be exceeded by 2-3 weeks.
Uniform data for UPD
Even if proactive use for approvals and variations requiring review (VRA) is not required, all data on the medicinal products are constantly exchanged with the UPD.
This means that certain data - regardless of the procedure - often have to be provided in a correctly structured manner by the applicant / marketing authorisation holder in order to avoid generating errors.
This data includes, among others:
- Organisation Management Service (OMS)
Detailed information can be found in the EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database:
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eu-implementation-guide-ig-veterinary-medicines-product-data-chapter-2-format-electronic-submission_en.pdf
