The formal publication of the Delegated Regulation marks the start of the 3-year implementation timeline to achieve compliance by the early 2019 deadline that comes into force across Europe. Central to the EU-FMD and the DR are the requirements that all prescription medicines (with few exceptions) will have to bear these safety features that will allow verification of their authenticity and provide proof that the outer packaging has not been manipulated.

Medicinal products in scope will need to be verified systematically at the point-of-dispense (i.e. pharmacy) supplemented by a risk-based verification in the supply chain, and additionally, a Europe-wide infrastructure of ‘national repository systems’ will need to be established, in which the safety features will be verified.

The Delegated Regulation is fully in line with the key principles under which the stakeholders have worked so far at European level, such as the harmonisation of the safety features and the modalities for verification of their authenticity. Furthermore and as a cornerstone, it entrusts the supply chain stakeholders to set up and manage, under the supervision of Member States’ competent authorities, an interoperable and cost-effective verification system for Medicines across all EU and EEA countries.

The stakeholders in the European pharmaceutical supply chain, EFPIA, EGA, EAEPC, GIRP and PGEU, have already made great strides, by establishing the European Medicines Verification Organisation (EMVO) in early 2015, and by setting up the centrepiece of the system’s infrastructure, the European Hub that will connect all national systems to ensure their interoperability (and that is today up and running and on-boarding manufacturer).

Attention will now turn to the establishment of the National Medicines Verification Organisations (NMVOs) in every Member State in the EU and EEA, a process that will gather pace through 2016 and that the EMVO is supporting with the blueprint system approach for NMVOs.