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Public Health (09-02-2016)

New safety features to protect EU consumers from falsified medicines

A delegated regulation - published today in the Official Journal introduces obligatory ‘safety features’ for medicines in the form of a unique identifier and an anti-tampering device.

Such safety features will protect European citizens against the health threat of falsified medicines, which may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage.

The safety features will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain - from manufacturers to distributors to pharmacies and hospitals.

The act in question supplements the Falsified Medicines Directive (2011/62/EU), which aims not only to close any existing gaps or loopholes which allow falsified medicines to reach patients, but also to allow EU citizens to buy medicines online through verified sources and ensure that only high quality ingredients are used for medicines in the EU.

The delegated Regulation will be applicable three years from today.