What are falsified medicines?
Falsified medicines are “fake” medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of poor quality or of the wrong strength – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy, this could be detrimental to patients’ health.
What is the Falsified Medicines Directive?
On 2nd January 2013, to combat the increasing risk that falsified medicines reach patients, the Falsified Medicines Directive (Directive 2011/62/EC) was published. This European Union Directive aims to prevent the entry into the legal supply chain of falsified medicinal products. On 9th February 2016, the Commission Delegated Regulation (EU) 2016/161 was published, which sets out detailed rules for new safety features to appear on the packaging of medicinal products intended for human use.
From 9th February 2019, market authorisation holders are required to place two safety features on all new packs of prescription medicines placed on the market in Europe:
- a unique identifier (UI) in the form of a 2D data matrix (barcode) which can be scanned at various points along the supply chain to determine its authenticity; and
- an anti-tampering device (ATD).
In order to comply with the requirements of FMD, community pharmacies will be required as part of the dispensing process (from 9th February 2019 and for products that bear safety features) to:
- check the anti-tampering device (ATD) to ensure it is intact prior to dispensing; and
- change the status of the pack in the UK’s National Medicines Verification System from “active” to “inactive—supplied”. This involves scanning the 2D barcode on each pack and communicating with the National Medicine Verification System.
What is the National Medicines Verification System?
The UK’s National Medicines Verification System is the UK FMD system. It is provided by SecurMed UK (the National Medicines Verification Organisation). SecurMed UK comprises bodies representing manufacturers, importers, wholesalers and pharmacies; community pharmacy is represented jointly by the National Pharmacy Association and the Company Chemists’ Association.