Serialisation legislation could improve recall process for drugmakers, says exec

By Flora Southey contact

- Last updated on GMT

Impending EU serialisation regulations could enhance drug recall procedures for pharmaceutical companies, says executive.

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.”

Related news

Show more

Related products

show more

The battle of performance in pharma production

The battle of performance in pharma production

Telstar Life Science Solutions | 26-Mar-2019 | Case Study

Telstar case study. Discover how a versatile freeze-dryer automatic loading & unloading systemDiscover how a versatile freeze-dryer automatic loading...

Accelerate your supply chain as pressures intensify

Accelerate your supply chain as pressures intensify

William Reed | 17-Sep-2018 | Technical / White Paper

Food, Drink and Non-Food manufacturers are under pressure. Range reviews, massive retail mergers, the backlash against plastic packaging and the ongoing...

Related suppliers

Follow us


View more