The Romanian Medicines Serialisation Organisation
It ensures the implementation of Directive 2011/62/EU (FMD) and of the Delegated Regulation 2016/161 (EU) of the European Commission so as to prevent the entry into the legal European supply chain of falsified medicinal products.
Who is OSMR?
The Romanian Medicines Serialisation Organisation (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 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.
To whom it is addressed to:
Marketing Authorization Holders & Parallel Import Authorization Holders
MAH & PIAH
The Marketing Authorization Holders and the Parallel Import Authorization Holders connect to the European Hub via the OBP (On-Boarding Partner) and ensure that the information related to medicines with unique identifiers is uploaded to the European Hub.