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Recipharm plans to invest €40 million in the project as a result of EMA decision to make serialization of licensed drug products a legal requirement by 2019.
Recipharm, a Sweden-based contract development and manufacturing organization (CDMO), plans to invest €40 Million ($44.4 million) over the next three years in solutions for serialization processes, the company said in a Feb. 10, 2016 press release. The decision comes just days after the European Medicines Agency (EMA) announced plans to implement packaging safety features as part of the Falsified Medicines Directive (Directive 2011/62/EU) (FMD), adopted in July 2011. The serialization of licensed drug products will be a legal requirement for companies in the EU starting in 2019.
Recipharm currently provides serialized products in Turkey, Korea, and China. The company has established a global steering committee that will work closely with clients in Europe to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialization.
“As a company, we are aiming to be as proactive as possible with the introduction of serialization in order to support and advise our clients, create a clear strategy and prepare them for inevitable changes,” said Staffan Widengren, director of corporate projects at Recipharm and leader of the company’s serialization project, in a press announcement. “If companies are underprepared, the new requirements have the potential to significantly impact their product supply. As a result, we expect to see increased demand for specialist outsourced services as the deadline looms ever closer.”
The company said they also plan to be ready for US serialization starting in November 2017, in-line with the US Drug Supply Chain Security Act (DSCSA).