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.
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: https://support.ema.europa.eu/esc?id=ec_dashboard
Public UPD-access: www.medicinesinfo.eu/de
UPD contact point
If you notice missing products or unclear information in the UPD, please contact our UPD contact point upd-contact@ages.at.
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:
1. Organisation Management Service (OMS)
Please note the creation of address entries in the EMA’s Organisation Management System (OMS) is mandatory. 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
2. Submission of Annual Volume of Sales
According to Article 58(12) of Regulation (EU) 2019/6, all Marketing Authorisation Holders must submit the annual Volume of Sales for each veterinary medicinal product to the Union Product Database (UPD).
The deadline for submitting the data is the end of February of the following year.
For further details see the CMDv website and EMA UPD webpage.
