Bucharest, February 7th, 2019 – The Romanian Organization for Serializing Medicines (OSMR), marks today, in Bucharest, during the press conference: „Patient Safety through Medicines Safety”, the fact that in two days the National Medicines Verification System (NMVS) becomes operational in Romania, providing patients, as well as all those who are part of the production and […]
Vă invităm să consultați ultima versiune a documentului „Întrebări și Răspunsuri” referitoare la „Elementele de Siguranță pentru Medicamentele de Uz Uman”, disponibilă pe site-ul Comisiei Europene (https://ec.europa.eu/health/human-use/falsified_medicines_en) – Q&A – versiunea 21
Please find below the latest version of the EMVS Master Data Guide, version 3.0 (available on the EMVO website – Knowledge Database page, OBP section). The document clarifies the notion of “Designated Wholesaler” – https://emvo-medicines.eu/new/wp-content/uploads/EMVO_0122_EMVS-Master-Data-Guide-2.pdf
We are getting closer to the project Go-Live – February 9th, 2019, only 30 working days left until the FMD comes into force, until the initiative to ensure patient safety by preventing the entry of falsified medicinal products into the legal supply chain becomes a reality. Great effort has been put into this one-of-a kind […]
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://staging.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 […]
The 1473 / 22.11.2018 Order of the Ministry of Health was published in Monitorul Oficial on December 5th, 2018 – establishing the framework for the implementation of the Commission’s Delegated Regulation (EU) 2016/161 of October 2nd 2015 stipulations which come as an addition to the European Parliament and Council’s Directive 2001/83/EC by setting detailed rules […]
An updated version of Questions & Answers has been released by the European Commission. We highly recommend that you have a look on the document, please click here: https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_en.pdf
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 […]
According to the European Medicines Verification System national implementation project Steering Committee decision taken on November 15th, OSMR announces the extension of the tests scheduled within the PILOT phase until January 15th, 2019. The OSMR test coordination team will align between the MAHs who have already transferred the complete data to the NMVS PROD environment […]
The first medicine pack scanned in NMVS PROD environment On November 5th 2018, the scanning of the first medicine pack in the NMVS PROD environment was carried out in Romania by Europharm Holding SA, authorized wholesaler. The Implementation of the National Medicines Verification System (NMVS) has reached an important milestone through the first real operation […]