Starting with October 15th, 2018, the legal entities that need to comply with the legal requirements as stated in the Delegated Regulation EU 2016/161, through the National Medicines Verification System (NMVS) can request access to NMVS directly, without prior notification from the local IT solution provider, by filling in the Application Form (Document Code: OSMR-PSO-0008/F1; download at: https://tinyurl.com/y8ycxp58), signing with an extended electronic signature or electronic seal and sending it to: [email protected]
The minimum conditions that need to be fulfilled by NMVS users, can be viewed here:
https://osmr.ro/english-cerinte-minimale-tehnice-si-procedurale-necesare-pentru-utilizatorii-finali/?lang=en
In order to acquire the End User status in NMVS, there are a number of steps which need to be followed by the legal entities that are directly envisaged by this project. First of all, the End User account is created in the OSMR Register and Incident Management System (OSMR SIMI), after which a collaborative process is undertaken, together with OSMR, to obtain access to the End Users’ technical documentation, followed by the account being created in NMVS PROD.
We would like to remind the wholesale distributors, the open-circuit pharmacies and the hospitals – in the broad sense of units authorized by the Ministry of Health for medical services and which are authorized to decommission medicines to the population (with or without closed-circuit pharmacies) – that they must perform operations in NMVS based on the Delegated Regulation 2016/161.
We recommend starting the End Users’ registration process by sending the above-mentioned form, filled in, by October 31st, 2018, so there are no time and resource constraints in the management of this process by OSMR.
