Implementing the Falsified Medicines Directive: Safety Features

European Union (EU) member states had until 9th February to implement the final part of the Falsified Medicines Directive (FMD). Member states are required to implement the new falsified medicinal products for the majority of prescription-only medicines, which aims to prevent falsified medicinal products from entering the pharmaceutical supply chain.

The safety features consist of a unique identifier (UI), in the form of a 2D data matrix barcode, and an anti-tampering device. Either the pharmaceutical manufacturer or marketing authorisation holder (MAH) must upload the information from the 2D data matrix barcode into the European data repository after collection, but before the product is released for sale or distribution.

At various points in the supply chain, the 2D barcode will be scanned and the anti-tampering device will be checked to verify that it is an ‘authentic’ medicine. Once supplied to the patient, or upon export or conversion, the UI must be disabled by scanning the barcode and removing the serial number from the FMD system. It is important to ensure that the anti-tampering device is intact when the medicine is dispensed to the patient.

The Medicines and Healthcare products Regulatory Agency (MHRA) have addressed how to handle the error messaging and false alerts that may occur in the system. It is key for end users to follow the advice from the MHRA, and where checks lead to a suspected falsified medicine then it should be reported under the Yellow Card Scheme by entering details under the ‘fake’ category.  If the MAH is notified by the alerting system that a data error has occurred, they are responsible for notifying the MHRA if after further investigation falsification is suspected.

The prospect of a hard Brexit is raising questions regarding whether the United Kingdom (UK) will have access to the EU repository of centralised data, which would create problems for UK stakeholders in verifying the UI on each medicine’s package. The MHRA have noted that if a hard Brexit were to occur, the legal obligation to follow the FMD would not apply to products within the UK, however the agency would still accept products with FMD safety features, as long as they are in compliance with UK packaging requirements.

To read more on implementing the FMD, please click here.

The MHRA Inspectorate have also written a blog on the FMD, which can be read here.