• Within the European Union there is an alarming growth in the number of medicines found to be falsified in terms of their identity, history or source. Prior experience shows that such falsified medicines reach patients not only through illegal means, but also through the legal supply chain. This poses a special threat to human health and can lead to patient’s mistrust of the legal supply chain, too.

    Consequently, the European Union stipulated, through Directive 2011/62/UE, the establishment of a Community code on medicinal products for human use to prevent the entry of falsified medicinal products into the legal supply chain. The Directive requires the introduction of safety features consisting of a unique identifier and an anti-tempering device placed on the packaging of certain medicines for human use in order to allow their identification and authentication. Within the Delegated Regulation (UE) 2016/161, The European Commission established a set of detailed rules for the safety features appearing on the packaging of medicines for human use. Starting with February 9th 2019, only prescription medicines which bear the new safety features may be put into circulation.

    The Romanian Organization for Serializing Medicines (OSMR) is a non-governmental, autonomous, independent, apolitical and non-profit organization, established for the implementation of the European Directive no. 2011/62/EU of June 8th on falsified medicines and the Delegated Regulation 2016/161. OSMR is also responsible for implementing and managing the National Medicines Verification System (NMVS), a verification platform through which pharmacies or other stakeholders, such as wholesalers in Romania, can verify the authenticity of a product.

News

    • APRIL 10, 2019

    EMVO – Letter of Announcement – Expiry Date Mismatch

    EMVO has sent a Letter of Announcement, providing important advice to OBPs on how to avoid causing false alerts by ensuring that the expiry date printed upon the Data Matrix Code matches that which is loaded into the EMVS. The letter can be downloaded here: Download PDF .emd_dl_red_darker { -moz-box-shadow:inset 0px 1px 0px 0px #f5978e;Read more
    • APRIL 10, 2019

    Common Causes of Alerts in the National Medicines Verification System

    Apart from the fact that product master data has not been uploaded to the European Medicines Verification System - EMVS or that the product pack data has not been uploaded to EMVS, another root cause for the Alerts is represented by: Scanner Configuration Issues. Scanner Issues As a rule, what is encoded must be perfectlyRead more