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The Romanian Medicines Serialisation Organisation
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 Medicines Serialisation Organisation (OSMR) is the 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.
MANAGEMENT
| Name | Function | Association |
|---|---|---|
| Dan Zaharescu | President | ARPIM |
| Viorica Predună | APMGR | |
| Coralia Kreyer | ADEM | |
| Mona Steriu-Ianulle | ADRFR | |
| Florina Bonifate | CFR | |
| Laurențiu Mihai | General Manager | OSMR |
Founding Members
They decided by mutual agreement to legally establish the Association “Organizația de Serializare a Medicamentelor din România” – The Romanian Medicines Serialisation Organisation
Because patient health and safety are of the utmost importance to the pharmaceutical industry, a strategy at European level is required. Consequently, the European Medicines Verification Organisation (EMVO) was created, as a joint initiative of EU stakeholders, representing the innovative medicines manufacturers (EFPIA) and the generic ones (Medicines for Europe), pharmaceutical distributors and retailers (GIRP), parallel distributors (EAEPC) and community pharmacists (PGEU).
The European Medicines Verification Organisation (EMVO) has taken responsibility for setting up the European Medicines Verification System (EMVS), in accordance with the EU’s Falsified Medicines Directive (FMD) and the Delegated Regulation (DR). It ensures the implementation of a functioning, secure, interoperable and cost-effective system across Europe.