Letter to Stakeholders Regarding the Implementation of Safety Features Under the Falsified Medicines Directive 2011/62/UE Letter-to-stakeholders-on-obligations_17.10.2018
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 […]
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; […]
Astazi, 28.09.2018, a fost publicat proiectul OMS privind normele metodologice de aplicare a Regulamentului Delegat 161/2016: http://www.ms.ro/acte-normative-in-transparenta/ Termenul limita de transmitere a observatiilor este de 10 zile de la publicare.
The End-Users registration process for NMVS access, according to the OSMR working procedures, is run as follows: 1. The software company serving the End-User, notifies the respective entity to OSMR via the OSMR SIMI System – Registering and Incident Management System; 2. The End-User is notified by OSMR to start the registration process; 3. The […]
As it has been communicated previously, a very important milestone has been reached in the National Implementation of the European Medicines Verification System: Romania successfully passed the second EMVO (European Medicines Verification Organization) assessment, thus the National Medicines Verification System is now connected to the EU Hub production environment (more on this, please visit our […]
The Romanian Medicines Verification System Goes Live! Dear FMD Stakeholders, It is with great pleasure that we announce the connection between the Romanian Medicines Verification System and the EU Hub production environment. Our organization adds another significant keystone to attaining its mission: ensuring patient safety through medicine safety. Such a challenging endeavor can only be […]
NEWS
Issuing of Order no. 985 of August 6th 2018 amending and bringing additional information to the Norms on the authorization of wholesale distribution units of medicinal products for human use, certification of good distribution practice and registration of brokers of medicinal products for human use, approved by the Order of the Minister of Health no. 131/2016.
Issuing of Order no. 985 of August 6th 2018 amending and bringing additional information to the Norms on the authorization of wholesale distribution units of medicinal products for human use, certification of good distribution practice and registration of brokers of medicinal products for human use, approved by the Order of the Minister of Health no. […]
The initiation of the PILOT phase within the national Project of implementing the European Medicines Verification System – EMVS We inform you that on July 31st 2018, the meeting between OSMR technical team and the representatives of the software solution providers was held so as to align the next steps to be undertaken during the […]
According to the OSMR Working Plan, the next period is dedicated to setting the base for the implementation of the PILOT phase, which, according to the decision of the Steering Committee of July 16th 2018, will begin in August and will last until the end of October, this year. A significant milestone in implementing the […]