What is the Falsified Medicines Directive (FMD)?

Falsified medicines are “counterfeit” medicines that attempt to pass themselves off as the real deal. Falsified medicines might contain ingredients which are poor in quality or the incorrect strength – either too high or too low. Because they have not been properly assessed to check their quality, effectiveness and safety, they could expose patients to potentially lethal health risks.

To combat the growing risk that falsified medicines reach patients, the Falsified Medicines Directive (Directive 2011/62/EC) was published on 2nd January 2013. This European Union Directive intends to inhibit the entry of falsified medicines into the legal supply chain. The Commission Delegated Regulation (EU) 2016/161 was published on 9th February 2016, this sets out the comprehensive rules for new safety features to be present on the packaging of all 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-tamper device (ATD).

In order to comply with the requirements of FMD, pharmacy contractors will be required as part of the dispensing process 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 (NMVS). This is where we can help >