Open consultation

Implementing ‘safety features’ under the Falsified Medicines Directive

Summary

This consultation invites views on the proposed steps we intend to take to make sure the UK meets its obligations to transpose the 'safety features' provisions of the Falsified Medicines Directive (FMD).

This consultation closes at

Consultation description

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

Documents

Final consultation document - FMD Safety Features

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FMD Safety Features - Consultation Impact Assessment

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Draft FMD Statutory Instrument

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Ways to respond

Published 16 July 2018