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The Romanian Organization for Serializing Medicines


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.

OSMR

Medicines’ SerializationMedicines’ AlertsSafe access to non-falsified medicinesEnsuring patient’s safety through medicine’s safety

The Romanian Organization for Serializing Medicines

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 Organization for Serializing Medicines (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 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:

End Users

Pharmacies

Verify the safety features and decommission the unique identifier when supplying the medicine to the patient.

Hospitals

Verify the safety features and decommission the unique identifier when supplying the medicine to the patient.

Wholesalers

Verify the authenticity of the unique identifiers of medicines’ packs.

Parallel Import Authorization Holders

Verify the authenticity of the unique identifiers of medicines’ packs.

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.

Connecting to the NMVS

Software Providers

The registration process for access to the documentation and support for connecting your clients to the National Medicines Verification System is done by your company by going through the detailed procedure found on Arvato’s site (NMVS solution provider)

The National Medicines Verification System

How does the NMVS work?