Application of the Falsified Medicines Directive: Safety Features in Northern Ireland

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.

The final part of the Directive, the ‘safety features’ Delegated Regulation (EU) 2016/161 came into force on 9 February 2019, and applies to certain categories of prescription only medicines (POM) and certain named non-prescription medicines.

Following the UK’s departure from the EU, the ‘safety features’ Delegated Regulation (EU) 2016/161 no longer applies in Great Britain (England, Scotland and Wales) but still applies in Northern Ireland.

For the latest guidance from the MHRA (updated 23/01/2023) visit