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Jun 24, 2019

Serialization systems and European legislation: MG2 Track & Trace

It is time to serialize for the European drug market. In fact, since last February the 9th it is compulsory to comply with the standards required by the FMD Directive (Falsified Medicines Directive).

Serialization is a central topic for the pharmaceutical market. In fact, if on the one side it affects both the economic aspect and the safety issues regarding patients’ health, on the other side EU wants to give an answer by imposing the EMVS, the European Medicines Verification System. 
In 2017, the commercial value of counterfeit drugs has reached important figures with almost 600 million euro of goods confiscated in Customs. A phenomenon which the European Union has decided to stop, by requiring its Member States to modernize production lines with serialization systems, thus enabling product traceability.

At the head of the process, there is the EMVO – European Medicine Verification Organization – together with its local organizations in the member states which, with different compliance dates, are obliged to implement the new system, thus integrating it with its own control procedures.

The design of serialization systems is a mission which has involved MG2 for several years by allowing the development of systems in compliance with the international standards in terms of traceability.

ACE Track & Trace systems indeed make it possible to carry out both the marking and the verification of cartons, bottles and bundled products in the end of line.

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