Related to the technical solution in use, we kindly inform you regarding the use of the EAN Location Code (GLN \u2013 Global Location Number), accredited according to ISO 6523 \u2013 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\u2019s Locations) and PTC (Technical Connection Points):
\n\u2013 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).
\n\u2013 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).
\n\u2013 By clearly identifying the locations, it provides accurate and complete data related to:
\n\u2013 a) compliance with legal obligations and role management;
\n\u2013 b) establishing identity;
\n\u2013 c) tracking operational flow (e.g.: restricting access for a LUF User or sub-user from PTC for operational reasons);
\n\u2013 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.
\nThis coding scheme is the only one identified by our specialists, from ISO 6523, which has a coding authority well known in Romania.
\nThe 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.
\nThe minimum technical and procedural requirements for End User\u2019s are available at this link:
\nhttps:\/\/osmr.ro\/english-cerinte-minimale-tehnice-si-procedurale-necesare-pentru-utilizatorii-finali\/?lang=en
\nOn October 5th, 2018, OSMR facilitated a meeting between professional associations\u2019 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.<\/p>\n
Definitions:<\/p>\n
LUF\/End-User Location \u2013 any physical or functional location of the End User accessing the NMVS in order to cover the legal obligations;
\nPTC\/TCP \u2013 Technical Connection Point \u2013 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.<\/p>\n","protected":false},"excerpt":{"rendered":"