Project Manager, Farmak Serialization and Aggregation System Implementation

Nov 15, 2019

EU countries: mandatory serialization and product tracking

The final part of Directive 2011/62/EU as regards the prevention of the entry into the legal supply chain of falsified medicinal products (FMD) came into effect on February 9. The European Medicines Verification System (EMVS) was created and launched, and JSC “Farmak” had to fulfil its requirements to export its products to the EU.

In accordance with the new requirements, the information on the medicinal product determined by the Delegated Regulation (EU/2016/161) on the safety features – a unique identifier (UI) – must be uploaded to the European Hub (EU Hub), which serves as the database of all packages of medicinal products coming on the EU market after February 9, 2019. It serves as a link between the participants in the supply chain and national repositories and facilitates the interaction of national systems. The European Medicines Verification Organization (EMVO) is responsible for the EU Hub and assists pharmaceutical companies to connect to the system. Once connected, pharmaceutical companies can upload unique identifiers for their medicinal products to the EU Hub.

It is important to note that the information on serial numbers is transmitted to the EU Hub by the marketing authorisation holder (MAH) or an on-boarding partner (OBP) in the case of a group of companies or contract manufacturing organisations (CMO).

Each pharmaceutical corporate entity shall appoint an on-boarding partner (OBP) to EMVO or is such if it holds a manufacturing authorization. OBP shall represent MAH before EMVO and is responsible to manage the upload of data and information about MAH’s licensed products into EMVS via the EU Hub. OBP has been designed to reduce the number of connections to the EU Hub and thus ensure the safety and security of the data.

Farmak, as all Ukrainian manufacturers, is not a resident of the European Union and may not be MAH. In the European markets, we transfer the rights to distribute a particular medicinal product to MAH, and Farmak is a contract manufacturing organisation. The contract manufacturing organisation and MAH may use either one or different system integrators, i.e. different reverse engineering software, so that the serialization report finally gets into the EU Hub.

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