An overview of the changes to the requirements for medicines ‘safety features’ following the UK’s departure from the EU

Falsified Medicines Directive (FMD)

The EU, Falsified Medicines Directive (FMD) Regulation (EU) 2016/161 was adopted in 2011 to ensure the trade in medicines across the European Union was properly controlled. The final part of the Directive, the ‘safety features’, came into force on 9 February 2019. This included a requirement for a Unique Identifier (UI) 2D data matrix barcode and anti-tamper devices on the packaging of certain medicines.

Change to requirements post EU exit

After the UK left the European Union, the ‘safety features’ regulation no longer applies in Great Britain. There is therefore no longer a regulatory requirement for medicines with a marketing authorisation valid in Great Britain (PLGB) to incorporate a 2D data matrix barcode and anti-tamper devices into the packaging. The requirements currently still apply in Northern Ireland, however, this may be subject to change and this page will be update when further information is available.