Related to the technical solution in use, we kindly inform you regarding the use of the EAN Location Code (GLN – Global Location Number), accredited according to ISO 6523 – Information Technology (Structures for identifying the organizations and parts of the organization), used for a unitary identification with a default allocation for: HQ, LUF (End User’s Locations) and PTC (Technical Connection Points):
– The NMVS (National Medicines Verification System) configuration solution with the use of this global identification scheme aims to ensure operability for all relevant activity areas (producer, wholesaler, pharmacy, hospital).
– It ensures also the access to any entity in RO/EU/EEA, including the same legal entity with several qualities (e.g.: wholesaler and chain of pharmacies, organizations).
– By clearly identifying the locations, it provides accurate and complete data related to:
– a) compliance with legal obligations and role management;
– b) establishing identity;
– c) tracking operational flow (e.g.: restricting access for a LUF User or sub-user from PTC for operational reasons);
– d) security (including valid data for audits) or in the event of a falsification alert (which will reach the MAH, located anywhere in the EU) or any type of investigation, including criminal investigations, initiated in any country that is part of the European Verification System.
This coding scheme is the only one identified by our specialists, from ISO 6523, which has a coding authority well known in Romania.
The solution was validated by the OSMR Board of Directors on the basis of discussions from the Working Groups organized by OSMR with stakeholder participation. It was reconfirmed during the OSMR General Assembly Meeting.
The minimum technical and procedural requirements for End User’s are available at this link:
https://osmr.ro/english-cerinte-minimale-tehnice-si-procedurale-necesare-pentru-utilizatorii-finali/?lang=en
On October 5th, 2018, OSMR facilitated a meeting between professional associations’ representatives (ARPIM, APMGR, ADEM, ADRFR, CFR) and the representative of the GS1 Non-Profit Association from Romania, during which the basic principles of collaboration between entities which have obligations in the implementation of medicines serialization and GS1 Romania Association have been agreed upon.
Definitions:
LUF/End-User Location – any physical or functional location of the End User accessing the NMVS in order to cover the legal obligations;
PTC/TCP – Technical Connection Point – is the IT terminal connected to the scanner, having internet access, on which the digital certificate used for authentication is installed and which has the NMVS connecting application installed to send and receive automated messages to/from the NMVS.
