A new resource hub has been launched to provide pharmacists with detailed information to help them prepare for the start of the EU Falsified Medicines Directive.
FMD Source is being provided by the UK FMD Working Group for Community Pharmacy, which brings together all the main pharmacy bodies to influence and inform the implementation of FMD in the UK.
Raj Patel, chair of the UK FMD Working Group for Community Pharmacy, says: “We recognise that this will be a big change for everyone in the medicines supply chain, especially community pharmacists. That’s why we’ve been working closely with the Department of Health and the MHRA to ensure that this is implemented in a proportionate way that fully reflects the UK’s unique dispensing models.”
FMD Source will provide "an authoritative and reliable source of information on FMD – one that is based on the way UK pharmacies operate and not some theoretical ‘European’ model". It is designed to help UK pharmacies prepare for whatever new authentication systems are developed and introduced.
Under the EU Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).
The UK’s database will be developed by a new organisation, SecurMed UK, which comprises of all the main supply chain bodies representing manufacturers, wholesalers and pharmacies. Pharmacy is represented jointly by the NPA and CCA. Mr Patel of the NPA is the 'dispensing entities' director of SecurMed UK.
The costs of establishing each database will be borne by manufacturers of branded and generic medicines and parallel distributors though additional licensing fees. Pharmacies and wholesalers will be responsible for making their connections to the database, as well as for software upgrades.
The UK is unlikely to have left the EU before FMD scanning and authentication comes in to effect February 9, 2019. Other EEA countries and Switzerland are also participating in FMD. But the full implementation of FMD may depend on the UK’s future relationship with the EU.
Pack serialisation is now a global approach to tackling falsification and similar systems are being developed in many markets, including India and China. As a result, serialised packs are already appearing in UK pharmacies.