Marketing Authorization Holders (MAH), regardless of the physical location of the medicine packs which bear the safety elements, perform the operations envisioned by the Delegated Regulation EU 2016/161 through the On-boarding Partner (OBP) in the European Hub, before any transfer to the first wholesaler.
Authorized wholesalers shall register in the NMVS and perform the operations envisioned by the Delegated Regulation EU 2016/161, on their behalf, for the products in their portfolio.
In the case of third party operations on behalf of the authorized wholesaler, based on a contractual relationship, the wholesalers’ End User Locations, which are hosted by the third party, and the Technical Connecting Points (TCP) and the software application pertaining to the third party are used.
The software company providing services for the third party, having the NMVS connecting software applications on its TCPs, who will perform the operations on behalf of the wholesaler (with the access credentials of the authorized wholesaler) has the obligation to register the respective wholesaler as End User in the OSMR Registering and Incident Management System.
For more information on the minimum technical and procedural requirements for End Users, please visit: https://osmr.ro/english-cerinte-minimale-tehnice-si-procedurale-necesare-pentru-utilizatorii-finali/?lang=en
