February 12th, 2016
Sharp, the leading international provider of healthcare services, is pleased to welcome the Delegated Regulation to complement the Falsified Medicines Directive (Directive 2011/62/EU) (FMD) published this week in the Official Journal of the European Union.
The aim of the directive is to reduce the occasions on which falsified medicines enter the legitimate supply chain.
Sales of counterfeit medicines are one of the most dangerous aspects of the worldwide trade in forged products. World Health Organisation (WHO) figures show that counterfeits account for one percent of drug sales in developed countries and up to seven times that figure in the developing world.
The delegated Act on Safety Features will address these issues. Coming into force in Europe as of 9th February 2019, the Act includes safety features; (i) a unique identifier (UI) consisting of a 14 digit global product number, Serial Number, Lot Number, Expiry Date, National Reimbursement Number carried by a 2-D barcode and (ii) an anti-tampering device (ATD) on the packaging of prescription medicines and certain non-prescription medicines for the purposes of authentication and identification. This legislation will be enforced for all prescription medicines, with some exceptions.
Commenting on the announcement, Rick Seibert, Senior Vice President Project Management & Technology Services at Sharp, said:
Sharp welcomes the new FMD regulations and is well-positioned to support companies in meeting this directive through their serialization requirements. Our expertise and track record in this area, investment to date, and future access to capital leaves us well placed to accommodate the new legislation.
“Having already been engaged in the serialization of individual unit dose pharmaceutical products for over eight years, I am convinced that our service exceeds the standards called for by the directive. It is crucial that patients are protected from falsified medicines and recalled products. Now that the deadline for enforcement has been set, we strongly urge companies to prepare for this and bear in mind the scale and cost of the task ahead.”
Sharp has serialized over two billion units of pharmaceutical products from their US and EU packaging facilities and currently has over 40 serialization projects running with customers across several international serialization legislations including the US, Europe, South Korea and China. Additionally, Sharp is rapidly expanding a rollout program based on the company’s expertise and use of proven software solutions.