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EU FMD Set to Go Live Across Europe and the UK
The final part of the European Falsified Medicines Directive (EU FMD) is to come into force on Feb. 9, 2019, which means that all medicines within the European Union will need to comply with the safety features as laid out by the delegated regulation.
The final part of the European Falsified Medicines Directive (EU FMD) is to come into force on Feb. 9, 2019, which means that all medicines within the European Union will need to comply with the safety features as laid out by the delegated regulation.
Two specific safety features are set out by the EU FMD as harmonized measures that will ensure the safety of medicines throughout Europe. These features include a unique identifier-a 2-D data matrix code and human readable information-and anti-tampering features/devices on medicine packs.
Through the measures required by the EU FMD delegated regulation, it will be possible for a product to be authenticated at every touch point once the product leaves the production line. This should, therefore, remove the risk of falsified medicines in the supply chain.
However, the Association of the British Pharmaceutical Industry (ABPI) has stressed its concern about the forthcoming Brexit, which is looking more likely to be a ‘no-deal’ scenario. In the potential ‘no-deal’ outcome, the United Kingdom will no longer be part of the new European system, which uses technology based on a cross-European database to authenticate medicines across the EU, according to a Feb. 8, 2019 press release from the ABPI.
“Billions of packs of medicines travel around the EU annually, destined for over 500 million patients. This new system means that patients across Europe will have the best protection from fake medicines in the world,” said Dr Rick Greville, director of Supply Chain at the ABPI in the release. “It would be an absolute travesty if National Health Service (NHS) patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no-deal’ Brexit. It is just another reason why we urgently need a Brexit deal.”
Mike Thompson, chief executive of the ABPI, added, “‘No-deal’ is not in the interest of the NHS or its patients. Not being part of the safest medicines system in the world, one that the UK has helped design and build––and which provides protection against fake medicines––makes no sense. Being part of a system that keeps them safe is the minimum that UK patients should expect.”
