Implementing ‘safety features’ under the Falsified Medicines Directive

The EU Falsified Medicines Directive (2011/62/EU) (FMD) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in the European Union (EU) are safe and that trade in medicines is properly controlled. Member States have until 9 February 2019 to implement the final part of the Directive, the ‘safety features’ Delegated Regulation. This consultation invites views on the proposed steps that the Government intends to take to make sure the United Kingdom (UK) meets its obligations to transpose the provisions of the Falsified Medicines Directive (FMD) requiring ‘safety features’ to appear on the packaging of certain medicinal products.

The detailed rules for the ‘safety features’ are set out in Commission Delegated Regulation (EU) 2016/161, but are essentially:

• a unique identifier (a 2D data matrix code and human readable information) that must be scanned at fixed points along the supply chain

• an anti-tampering device allowing verification of whether the packaging of a medicinal product has been tampered with