A date with data

The forthcoming publication of Delegated Acts associated with the EU Falsified Medicines Directive will signal the start of a race against time to meet new legislative obligations. Assigning and verifying a unique product identity at item level is potentially the most significant technical and logistical challenge that manufacturers have faced in decades, yet the evidence would suggest that much of the industry is still playing a waiting game. Domino’s Craig Stobie and Ian Haynes of 3C Innovation provide their blueprint for starting the serialisation journey.

Adopted in 2011 and aimed at stemming the flow of falsified medicines infiltrating the legal pharmaceutical supply chain within the European Economic Area, the EU Falsified Medicines Directive (FMD 2011/62/EU) will, within a few years, completely change the landscape of the European pharmaceutical supply chain.

The scope of the Directive places new obligations on all branches of the industry – manufacturers, generics producers, contract packers, re-packers, importers, wholesalers and distributors, and on any producer intending to supply pharmaceutical products into any of the EU 27 countries. Broadly the requirements fall into five categories:

• obligatory feature on the outer packaging of medicines to demonstrate that they have not been tampered with
• obligatory feature on the outer packaging of medicines to allow unique pack identification and enable product verification
• strengthened requirements for the inspection of the manufacturers of active pharmaceutical ingredients
• the obligation for manufacturers and distributors to report any suspicion of falsified medicines
• an obligatory logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers.

From 2016, once all parts of the Directive come into force, manufacturers failing to comply with any aspect of the above will no longer be allowed to market their products in Europe.