Serialisation legislation could improve recall process for drugmakers, says exec

The EU Falsified Medicines Directive​ (FMD) – due to come into effect on February 9, 2019 – aims to prevent entry of falsified medicines into Europe’s pharmaceutical supply chain.

However, IBI-Lorenzini’s operations director Luca Pezzano said the Directive may also help pharmaceutical companies reconcile drugs in the event of a recall.

“Product reconciliation is one of the biggest issues a drugmaker faces during a product recall,” ​Pezzano told delegates at TraceLink’s FutureLink conference in Munich last week.

Knowing exactly where a product is – thanks to its attributed serial number – could improve the chances of reconciling 100% of a recalled drug product, he said.

Epista Life Science consultant Pasi Kemppainen, who is currently management advisor of serialisation and traceability at Santen Pharmaceutical, agreed the FMD could improve the recall process for marketing authorisation holders (MAHs).

“We also need to understand that it’s not only prescription drugs that are recalled. It’s also OTCs [over-the-counter drugs] and medical devices, so the recall procedures need to be basically the same for all the product categories,” ​he told delegates.

According to Kemppainen, serialisation data could also be used by drugmakers to analyse the recall, and improve its transparency.

In the case of a recall, Santen would “definitely” want to see the data to ensure all recalled products had been received by third-party logistics (3PL) partners, he added: “Patient safety must come first.”​