Recipharm takes upfront costs out of serialization

Recipharm will allow its customers to spread the cost of the serialization projects, reducing their upfront investment.

The Swedish contract development and manufacturing organisation (CDMO) said the new pricing structure - a fixed service fee per pack for all customers - will make it easier for some pharma companies to prepare for serialisation mandates in the EU, US and elsewhere.

Companies must adapt their packs, implement their tamper evidence capability and establish the systems, processes and data to comply with the requirements, which become mandatory in November 2017 in the US and early 2019 in Europe.

The initiatives are expected to improve traceability of drugs, help in the fight against counterfeit products entering the supply chain and ultimately improve patient safety.

Recipharm will start offering serialisation at a fixed price per unit, with an option to customise packs to individual requirements. It will start offering aggregation - which is implicit in the European legislation and looks likely to be required in the US as well.

The company recently announced plans to invest €40m over the next three years to ensure state-of-the-art solutions for serialisation processes. As soon as the service is operational, the company will provide serialisation free-of-charge until the legal requirements come into effect to ensure drug developers are prepared ahead of the deadlines.

From 2023, the company intends to offer serialization as standard as part of its product manufacturing costs.

Staffan Widengren, director of corporate projects at Recipharm, said: "Many companies are behind in their preparations, not fully aware of the scale and complexity of the task ahead and concerned about the required financial investment."

The CDMO estimates that around 85 per cent of its 250-plus customers require serialisation.