Based on the good collaboration between OSMR and the companies providing professional IT services and applications for the pharma industry in the context of serialisation (the list of approved companies here: https://osmr.ro/solution-provider-it-pharma/?lang=en), a number of 3,159 organizations out of an estimated total of 3,200 are in the registering process in order to acquire the End User status in the NMVS (details about the process and minimal conditions can be found here: https://osmr.ro/english-cerinte-minimale-tehnice-si-procedurale-necesare-pentru-utilizatorii-finali/?lang=en).
Out of these, less than 200 are currently undergoing tests in the IQE NMVS environment aimed at testing the End User Locations based on the personalized Card for each End User Location (https://www.testsnvm.com).
We kindly ask all the notified organizations to urgently submit the Participation Request Form (https://tinyurl.com/y8ycxp58) needed for activating the End User Administrator account, assigned by the legal representative.
The End User Administrator has full responsibilities as to:
– receiving automated notifications with work instructions from the Register and Incident Management System (OSMR SIMI),
– downloading/uploading documents and technical documentation for implementation from/in OSMR SIMI on the account of that company (End User),
– defining End User Locations, including the PTCs needed which will be used: (see: the 1473/22.11.2018 Order of the Ministry of Health: https://osmr.ro/wp-content/uploads/2018/12/extras-MOf-1031_05.12.2018-Ordin-MS-1473-elemente-siguranta-ambalaje-medicamente.pdf and the detailed description of the national solution related to the identity management: https://osmr.ro/solutia-tehnica-folosita/?lang=en),
– managing IQE and PROD NMVS environment accounts for that End User and for the End User Locations representatives.
The organizations that have not received the participation information from OSMR (and therefore have not been notified by the IT companies), can register directly: https://osmr.ro/acces-direct-al-utilizatorilor-finali-la-snvm/?lang=en
OSMR informs that, according to its own estimates, in order to be able to comply with the Falsified Medicines Directive which becomes effective as of February 9th 2019, the maximum deadline for sending the Participation Request to [email protected] address is the first week of January 2019.
The registration process may take a week or more depending on how many End Users will leave this step for the last minute.
