A guideline for EUFMD implementation

The FMD: potential solutions

In Europe, about 1% of medicines, sold to the public through the legal supply chain is fake. To counter the growing threat of counterfeiting, the EU Commission passed the EU Falsified Medicines Directive—commonly known as EU FMD. This white paper gives an overview of these broad guidelines and provides directives for effective implementation.

No country is immune to the problems associated with counterfeit medicines. Across the planet, governments are enforcing new regulations and directives to counter the threat of illegal pharmaceuticals to public health and safety.

In this report, ACG examines the EU’s Falsified Medicines Directive – due to be rolled out on February 9 next year.

This pan-European regulation has created a challenging time for pharmaceutical firms, forcing them to rapidly understand exacting requirements, to execute complete implementation projects, and to fully optimize their business on an international scale. However, the potential value addition that international business process compliance will bring will be considerable.

This paper outlines the insights ACG have gained from their experience in Track & Trace implementation, highlights the challenges faced by pharmaceutical companies across the EU, and posits potential methods of overcoming them. With awareness of counterfeiting increasing, the pharmaceutical industry should be agile in the coming months, and learn to consider regulations as obligations in the years to come.

ACG is committed to understanding the challenges to implementation, and whether or not compliance is being achieved in the EU.

To find out more, download the full report.