The EU Falsified Medicines Directive (2011/62/EU) amended Directive 2001/83/EC and introduced harmonised European measures to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled. Measures include
- Obligatory safety features – a unique identifier and an anti-tampering device - on the outer packaging of prescription medicines
- A common, EU-wide logo to identify the legal online suppliers of medicines (pharmacies and other retailers). The register for Ireland is maintained by the PSI, the pharmacy regulator.
- Tougher rules on import of active pharmaceutical ingredients
-Strengthened record-keeping requirements for wholesale distributors.
Commission Delegated Regulation (EU) 2016/161, that supplements Directive 2001/83/EC, was adopted in 2016 and has applied in Ireland since 2019. This Delegated Regulation contains detailed rules for the safety features appearing on the packaging of medicinal products for human use, including scanning of the 2D barcode to authenticate the unique identifier and checking the integrity of the anti-tampering device. This legislation is legally binding and must be applied across all member states, including Ireland.
The Falsified Medicines Directive is part of a global move towards serialisation and traceability of medicines to protect the supply chain from falsified medicines and to harness the value of barcoding for other purposes to improve patient safety and business efficiency.
Pharmacies, hospitals and wholesalers in 29 countries are undertaking approximately 2.5 billion verification and decommissioning transactions per quarter across the entire European Medicines Verification System and there is no evidence to suggest that these high numbers of transactions are resulting in any patient safety issues. Scanning is well established in the ‘front of shop’ area of Irish community pharmacies but the requirement to scan prescription medicines in the pharmacy dispensary was new when it became law in February 2019. The ‘use and learn’ period that has been in place since then was designed in part to allow pharmacies to get used to scanning prescription medicines and work out to how build this extra step safely into their dispensing process.
