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Falsified Medicines Directive

FMD anti-tampering device can be verified at any time while in the pharmacy, European Commission says

Pharmacy staff can verify a medicine pack’s physical anti-tampering device (ATD) at any time, not only when the medicine is supplied to the patient, the European Commission (EC) has said.

The clarification comes in the latest version of the EC’s Q&A document on the Falsified Medicines Directive (FMD) ‘Safety features for medicinal products for human use’. The updated document, published on 28 September 2018, is the 11th iteration of the EC’s guidance.

The FMD legislation introduces new regulations for safety features on prescription medicine in a bid to prevent counterfeit medicines entering the formal supply chain. The safety features include a physical anti-tampering device that allows for visual assurance that a pack has not been tampered with. The other safety feature is a unique identifier for each pack, in the form of a 2D barcode — the barcode must first be scanned to verify the medicines’ authenticity and then scanned again at the point of supply to decommission the medicine.

The directive comes into force across the EU on 9 February 2019. More information can be found in The Pharmaceutial Journal’s special report on the FMD.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205523

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