Falsified Medicines Directive


The Falsified Medicines Directive (FMD) is the European Union (EU) regulation designed to protect the Member States from the threat of falsified medicines. It came into force in UK national law in August 2013. The Delegated Regulation of the Directive came into force in February 2016. This explains the details of the ‘safety features’ that all prescription medicines will have to carry and the ‘modalities’ of the process that will allow individual medicines to be verified throughout the legitimate supply chain, protecting patients from potentially dangerous, illegal drugs. This will see individual packs of medicines being allocated unique, 2D matrix codes that can be scanned to give details of authenticity.

The UK medicines supply chain now has until 2019 to fully implement the legally-binding requirements of this legislation.

HDA UK has been fully engaged at the national and EU level (through the European Healthcare Distribution Association (GIRP)): HDA has a voting Director’s seat on the UK Medicines Verification Organisation, incorporated as SecurMed UK, the group of stakeholders which is managing and co-ordinating the UK’s implementation of the Directive, alongside the Department of Health and the Medicines and Healthcare products Regulatory Agency (jointly known as the Competent Authority).

It is expected that during 2017, the UK’s Blueprint Service Provider (BSP) will be selected and the detailed work of building and developing the UK’s verification system will begin, with pilot systems introduced in 2017.

Regarding any impact from Brexit, the UK Government has told us: “Until exit negotiations are concluded the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force.  During this period, the government will continue to negotiate, implement and apply EU legislation including the ‘Safety Features’ policy under the Falsified Medicines Directive.   The outcome of the exit negotiations will help determine what arrangements will apply once the UK has left the EU, however the government remains committed to providing a regulatory environment which protects health and improves lives.”