Falsified Medicines Directive (FMD)
Posted on 8th January 2019 at 15:21
The European Falsified Medicine Directive (FMD) takes effect on 9th February 2019 and the new measures are being put in place to help combat counterfeit medicines and in doing so, improving patient safety.
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).
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