Falsified Medicines in the EU: New Features for Better Patient Safety

As of 9 February 2019, most prescription medicines supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging.

These mandatory safety features are implemented through a delegated regulation that comes into application on 9 February 2019. It will apply in all EU/EEA Member States, except for Greece and Italy, who have until 2025 to update their already existing tracking systems.

The safety features will help protect European citizens against the threat of falsified medicines, which put patients’ health at risk. The unique identifier and the anti-tampering device on the packaging of the medicines will guarantee medicine authenticity for the benefit of patients, and will strengthen the security of the medicine supply chain, from manufacturers to distributors to pharmacies and hospitals.

Manufacturers will upload the information contained in the unique identifier for each individual medicine to a central EU repository. The repository is part of an end-to-end medicines verification system (EMVS) introduced by the regulation. Depending on the source of the medicine, wholesalers will also need to scan medicines at different points in the supply chain to verify their authenticity. Pharmacies and hospitals will then scan each medicine at the end of the supply chain to verify their authenticity and check them out from the repository before dispensing them to patients. Although the safety features are now a legal requirement, medicines that were released for sale or distribution without the safety features before 9 February can still be dispensed.

For more information, see the recent guidance document from the European Medicines Verification Organisation (EMVO) here.

Source: EMA

January 16, 2019

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