What is the Falsified Medicines Directive?
In 2011, the European (EU) Commission published legislation, entitled the Falsified Medicines Directive, which aims to prevent falsified medicines entering the European supply chain. Follow-up legislation was published by the Commission in February 2016, setting out exactly what manufacturers, wholesalers and pharmacists need to do to ensure that the medicines supplied to patients are authentic. Safety features will become obligatory for most prescription-only medicines from the 9 February 2019.
What are the safety features?
All EU pharma companies (originator companies, generic companies and parallel distributors) will put a two-dimensional (2D) barcode on each pack of medicine. The 2D barcode contains a serial number which is unique to each and every individual product pack as well as the batch number, expiry date and a product code. They will also put an anti-tamper device (tamper-evident seal) on each pack.
What do Pharmacists need to do?
From 9 February 2019, if a pack has safety features on it, pharmacists must authenticate the unique identifier, contained in the 2D barcode, during the dispensing process; they must also ensure the anti-tamper device is intact. To do so, pharmacies must be connected to the national repository system managed by the Irish Medicines Verification Organisation (IMVO). They must have the necessary software, scanners and procedures in place to perform these tasks.
Packs without safety features placed on the market before 9 February 2019 may continue to be supplied by pharmacists until their expiry date, unless recalled before then.
IMVO will have contacted all pharmacies before the end of October with details of how to register with IMVO and connect to the national repository system. Further information is available on the IMVO website, including details of introductory webinars for pharmacists. IMVO will also make the webinars available for download and provide additional guidance to pharmacists on where to go for support. The IPU will also be assisting its members in getting ready for the 9 February deadline and has published articles, reports and a set of Frequently Asked Questions (FAQ) providing more information on the Falsified Medicines Directive – Medicines Authentication on its website.