Recipharm has released its first serialised products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.
In 2016 Recipharm committed to invest 40 million euros in preparing its facilities for the European Falsified Medicines Directive (EU FMD). The release of its first batch of serialised medicine to the European market is a significant milestone in the CDMO's journey towards compliance with the new regulation.
Recipharm’s other facilities across Europe will also be ready to release fully serialised products to Europe by the end of the year, two months ahead of the EU FMD deadline in February 2019.
Recipharm has already delivered over 2.5 million serialised packs to markets where serialisation regulations are in place, including China, South Korea, Saudi Arabia and Turkey, as well as 500,000 packs to the US. The company is implementing the technologies of cloud network provider TraceLink and software and hardware providers SeaVision and Marchesini.
Staffan Widengren, director corporate projects and head of the global steering committee for Recipharm’s serialisation programme said: “Over recent years Recipharm has become known for leading the way in meeting the serialisation challenge. We are proud to have reached this milestone four months before the FMD deadline and anticipate that all our facilities will meet compliance by the end of the year.”
Recipharm is also serialising its customers’ products for free until February 2019 to ensure a seamless transition when the regulation comes into force.
Staffan added: “Recipharm is keen to aid companies in meeting compliance on time and ultimately help to create a safer global medicine supply.”
This news follows the launch of Recipharm’s standalone serialisation service, which allows pharmaceutical companies to benefit from its serialisation capabilities as a standalone service even if their products are not manufactured by the CDMO. This will ensure that companies that have not yet prepared for the upcoming FMD deadline have a way to achieve compliance in time.
As part of the service, Recipharm will add 2D codes, human readable text and tamper evidence to pre-packaged medicines.