Safety Features - how is it progressing?

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7/8 May 2024

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The safety features element of the Falsified Medicines Directive (FMD) came into force across Europe on 9 February 2019. The MHRA will be issuing a series of blog posts regarding the implementation of the FMD over the next few months. The first post looks at the robustness of incoming checks.

How is the implementation of Safety Features progressing?

Since implementation, the MHRA has been inspecting for the required new elements. Despite of some excellent robust systems that have been brought in line with the FMD safety features requirements, the British authority has also seen some systems that required improvement and examples of systems that failed to identify falsified stock.

Incoming goods checks

The systems should be able to identify decommissioned, stolen or recalled stock. According to the MHRA, this should include not just using the 2D barcode unique identifier (UI) scanning systems, but also identifying stock from Greece and Italy that are yet to implement the 2D barcode UI system. Where the 2D barcode UI is not yet in use, it is till expected that falsified, stolen or recalled stock received into the systems is identified (including those that have already been decommissioned). MHRA Inspectors will be looking for this step as part of the incoming goods checks.

The European Commission (EC) has recently published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the FMD. In addition, specific guidance from Italian and Greek regulatory agencies on how to check incoming goods from these countries is compliant has been published on the GOV.UK guidance page.  

Please visit the MHRA blog How the implementation of Safety Features progresses 5 months in to find out more.