Recipharm has announced that all 15 of its facilities outlined in its investment plan are now fully prepared for drug serialisation and have delivered serialised batches within Europe ahead of the 9 February deadline. During the period 2016-2018, the CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers, ahead of the introduction of the EU Falsified Medicines Directive (EU FMD) and the US Drug Supply Chain Security Act (DSCSA).

In addition, all of the facilities are connected to customers to allow them to report serial numbers. The facilities are located across Europe in France, Italy, Sweden, Spain, Germany, the UK and Portugal, as well as in India.

Staffan Widengren, Director Corporate Projects, said: “Recipharm has been very committed to meeting compliance deadlines, establishing a dedicated task force 3 years ago. A lot of time and effort has gone into our preparations so it’s rewarding to report that we are ready, especially ahead of the enforcement date”.

“Standardising our serialisation capabilities has enabled us to provide a seamless and flexible service to our customers, across multiple markets”.

After months of operational upheaval, the EU FMD regulation is now in effect. As CDMOs try to adhere to serialization requirements, how could Brexit affect the new regulations and how does Recipharm aims to handle products during this period ?

"The uncertainty of Brexit lingers, pharmaceutical companies are still unsure as to how Brexit will affect the FMD requirements, said Staffan Widengren. He continued: "When the UK leaves the EU on Friday 29 March, it could be that the UK market does not require serialised products, whereas the EU will uphold the regulations. This means that when drug products are transferred from the UK to the EU market, they will still need to comply with FMD requirements.

"Ultimately, the operational approach of pharmaceutical firms will depend on whether the UK remains part of the current European Medicines Verification Organization (EMVO) or European Medicines Verification Systems (EMVS), like many of the European Election Studies (EES) countries, or if they decide to adopt a new and separate system.

"In the meantime, Recipharm will handle all products as EU products and report serial numbers to the EU Hub and national systems. It is imperative that pharma companies not yet compliant with the new regulation, outsource their serialisation requirements and co-operate with their partners as this will ultimately help to protect the safety of patients."

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