Module 12 2019

Presentation by Ivo Claasen – new Head of Veterinary The New Veterinary Regulation (NVR) will be implemented in 2022 One of the requirements is the establishment of Union Product Database (UPD), article 55 New Veterinary Regulation (NVR) The UPD will be populated by the NCAs: Name, active substance and strength, SPC, package leaflet, public AR, list of manufacturing sites. In addition, MAH will enrich the data: date of placing the product on the market, volume of sales, information on the availability, variations not requiring assessment EMA looking for Minimal Viable Product (MVP) by end 2021 which can be later enhanced. UPD needs to be linked to PV, EudraGMDP, sales and use data for antimicrobial, MRL database, NCA/EMA databases and MAH databases if possible. EMA looking into 2 options: 1) Use SPOR - Questions about deliverable 2) Using a different approach - To be suggested by relevant groups of the telematics governance

Phase III decision (about IT architecture) end of this year.

Raised question about the use of SPOR by all NCAs. Aware of the issue, once there is a decision to use SPOR, there will be further decision to inform NCAs on next steps

The Organisation for Professionals in Regulatory Affairs