EU mandates new safety features to fight counterfeiting

New legislation is welcomed by Sharp Packaging Solutions

The European Medicines Agency (EMA) and the European Commission have ordered the use of two safety features to prevent the sale of counterfeit medicines.

These are: a unique identifier (consisting of a 14-digit global product number, serial number, lot number, expiry date, and national reimbursement number carried by a 2-D barcode) and an anti-tampering device.

The aim is to enable pharmacists to ensure that they are dispensing a legitimate product.

A new Commission regulation, using delegated powers, tells market-authorisation holders to place these safety features on packaging for most prescription medicines and certain non-prescription medicines by 9 February 2019.

The Commission said these safety features will 'help protect European citizens against the threat of falsified medicines, which may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage and could potentially put patients’ health at risk'. They will also 'strengthen the security of the medicine supply chain – from manufacturers to distributors to pharmacies and hospitals'.

These safety features will help protect European citizens against the threat of falsified medicines

The legislation details how these technologies should be used. The barcode should be a 'machine-readable data matrix and have error detection and correction equivalent to or higher than those of the data matrix ECC200'. The Commission added that barcodes conforming to the International Organization for Standardization/International Electrotechnical Commission standard (ISO/IEC) 16022:2006 will comply with the legislation.Manufacturers, wholesalers and retailers will have to check the unique identifier against those stored on a network of databases created by non-profit bodies established by pharmaceutical firms. These databases shall be fully interoperable and show 'full functional integration of, and electronic data exchange between repositories regardless of the service provider used.'

There is less detail on how manufacturers should install an anti-tampering device, but it must show whether the packaging 'has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic,' according to the legislation.

UDG Healthcare and its pharmaceutical packaging division, Sharp Packaging Solutions, have welcomed the new regulations.

Rick Seibert, Senior Vice President Project Management & Technology Services at Sharp Packaging Solutions, said: 'Sharp is well positioned to support companies in meeting this directive through their serialisation 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 serialisation of individual unit dose pharmaceutical products for more than 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 Packaging Solutions has serialised more than two billion units of pharmaceutical products from its US and EU packaging facilities and currently has more than 40 serialisation projects running with customers across several international serialisation legislations including the US, Europe, South Korea and China.

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