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Falsified Medicines Directive – Are you making the right preparations?

With the Falsified Medicines Directive (FMD) coming into effect from February 9, 2019, the spotlight is on the pharmaceutical industry to be better prepared for compliance with the enhanced security requirements.

Current Landscape

The current numbers are truly disturbing, with an approximate annual death toll of 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017. The regulatory authorities worldwide are pushing forward industry-wide discussions and stakeholder engagements focusing on the implementation and impact of the FMD. The legislation requires prescription medicines for sale to carry a unique and randomised serial number encoded in a 2D-barcode and a visible anti-tampering device.

Manufacturers will be responsible for uploading the serial numbers to a system of national databases linked by a European hub, and country-based national data repositories will allow verification at different times and final decommissioning when each pack is dispensed to a patient.

At each stage of the supply chain, the product will be inspected to ensure it has not been tampered with, has not previously been dispensed and that the packaging is intact. Additionally, good distribution practice (GDP) guidelines will require the individual product to be scanned to record the batch number and expiry date. This check will indicate whether the product is authentic and bring up information such as whether the product has been subject to a recall.

These actions, to be carried out across the pharmaceutical supply chain, are vital to its integrity and minimise the opportunity for the original product to be replaced with a counterfeit.

Preparation is Key

To ensure the successful implementation of FMD by companies, significant investment will be required both in financial terms and a commitment of time and resources. This will include interfaces with all stakeholders throughout the supply chain.

Many of the key distributors are already working with the regulators, stakeholder bodies, manufacturer partners and pharmacy customers to ensure all participants in the medicines supply chain are ready to safely implement the processes for medicines authentication in time. So the process is already in full swing; however, there are still many parts of the industry that have yet to embrace the impact of FMD and will need to start their strategic planning now – before it becomes too late. February 2019 may seem a long way off, but don’t underestimate the scale of change required and, in reality, there are less than two years to be ready and to develop, test and input new systems and working practices. Our experts at ELC Group can help you familiarise yourselves with the requirements and help you to plan your strategy for implementation, as well as help coordinate stakeholder interfaces.


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