Europe – Implementing the Falsified Medicines Directive: Safety Features

How to prepare for implementation and compliance of the Safety Features Regulation.

Introduction

This page is a hub of information for all stakeholders impacted by the implementation of FMD Safety Features. With both UK Government and stakeholder produced information; those impacted by the new Regulation can access the most up to date advice on how to prepare for the implementation of and compliance with the Safety Features Regulation. In addition to the guidance for all, stakeholders can access sector-specific guidance. This is segmented into stakeholder groups and you should review links to additional information that fall into the group category(ies) you or your organisation identifies as.

How the Falsified Medicines Directive works

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) comes into force on 9 February 2019.

These safety features are…