MHRA releases final consultation response for the Falsified Medicines Directive

A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders.

The Regulation on ‘safety features’ will automatically apply in all European Union (EU) Member States, thus as of 9th February 2019, these new requirements will be directly applicable as part of UK law.

The rules for the ‘safety features’ are outlined 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.

Topics covered in the consultation included national flexibilities in the Delegated Regulation, and the level of sanctions applied to a breach of each new requirement, for which the MHRA are obliged to take further legal steps, leading to the laying of a Statutory Instrument in Parliament. The majority of the responses broadly supported the Government’s proposed positions regarding the level of sanctions imposed and on each national flexibility, where the UK has legal scope to make changes.

To read the consultation on implementing ‘safety features’ under the FMD, please click here.

For further information and guidance on the FMD and ‘safety features’, please click here.