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Falsified medicines are fake medicines that are dispensed as real, authorised, medicines. In reality, falsified medicines may contain inactive molecules, or active ingredients which are of low quality or appear in the wrong dosage.

New rules to reduce falsified medicines

Since February 2019, the European Union applies new rules to the safety and quality control of medicines, based on the Falsified Medicines Directive that was adopted eight years ago.

The Directive and the delegated acts that followed have established, among others, a medicines authentication system (called ‘end-to-end system’) that requires now hospitals and pharmacies (including those operating online) to verify the authenticity of products.

Two new safety features to protect patients from falsified medicines

The new authentication system includes two safety features: a unique identifier and an anti-tampering device introduced by the manufacturers on the package of the medicine. These features will have to be checked at the point of sale before dispensed to patients.

The application of the rules is very timely given the rise in falsified medicines in all disease areas, including chronic conditions. Since falsified medicines have not gone through the necessary quality, safety and efficacy evaluation as required by the EU authorisation procedure, falsified or poor-quality medicines can compromise the treatment of chronic diseases, causing disease progression, drug resistance, and death.

Not surprisingly, the problem is more evident in low- and middle-income countries.

More information about falsified medicines in the European Commission website.