Falsified Medicines Directive update; view from the Netherlands

23 July 2018

The Falsified Medicines Directive (FMD) (Directive 2011/62/EU) is a measure to prevent falsified medicinal products for human use from entering the legal distribution chain. The Delegated Regulation 2016/161 gives effect to parts of the FMD and contains legal measures for the implementation of the Directive.

An important element in the delegated regulation is that all outer packaging of prescription-only medicinal products must bear safety features no later than February 9, 2019. These safety features are: a 2D matrix code and an anti-tampering device (eg, a seal on the outer packaging) that can verify whether the packaging has already been opened.

Supply and management of unique codes

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