An implementation plan for the Europe-wide introduction of measures to protect patients from fake or “falsified” medicines has been released by The European Medicines Agency. Safety features to be added to medicines packaging include a 2-D barcode and an anti-tampering device.
Falsified medicines could contain ingredients, including active ingredients, which are of low quality or in the wrong dosage, and could potentially put patients’ health at risk, says the EMA. The measures are being taken to help prevent falsified medicines from entering the legal supply chain and posing a risk to patients and to ensure that any medicines bought online are supplied through verified sources.
The new measures must be introduced for all medicines for human use across Europe by February 2019 – three years time.
It has previously been suggested the pharmacies may be required to scan the 2-D barcode.
Martin Sawer, executive director of the UK’s Healthcare Distribution Association, representing organisations in the medicines supply chain, commented: “It is good news to finally see the publication of the Delegated Regulation that sets the clock ticking in the UK and other EU member states.”
He welcomed the model chosen for the initiative, after long debate in Europe. “Alternatives would have placed unnecessary burdens on the supply chain, including delays in being able to supply life-saving medicines speedily to patients,” he said.