MHRA issues guidance on FMD safety features post-Brexit

The UK drugs regulator has at long last published its final draft guidance on the safety feature provisions of the Falsified Medicines Directive – and how the UK can meet its obligations.

The top-line message is that the UK’s exit from the EU next March won’t have any impact on the implementation, says the Medicines and Healthcare products Regulatory Agency (MHRA), as the EU withdrawal bill – implemented after Article 50 was triggered last year – means that the same rules and laws will apply in the UK immediately after exit (regardless if that is ‘soft’ or ‘hard’).

In a nutshell, the MHRA is confirming that the FMD’s requirements – including a unique identifier in a 2D barcode on medicine packs that can be scanned at fixed points along the supply chain and anti-tamper devices from February 9 next year – will still apply in UK law. To be frank, no-one expected otherwise, but it still leaves a short window for the government to finalise implementation plans – and with Brexit fast becoming a chaotic shambles it’s got a lot of other things to worry about.

“We understand the UK’s approach to implementation needs to be finalised as soon as possible,” acknowledges the MHRA in the document, which is open for consultation until September 23.

“The government is required to legislate nationally to accommodate the flexibilities around specific characteristics of the supply chain [and] sanctions are also required in order to make the provisions enforceable in the UK,” it notes.  The consultation includes a draft statutory instrument (SI) that for example would include a stepwise approach with civil sanctions first, followed by criminal sanctions in serious cases – something that the MHRA is seeking specific feedback on.

Other questions proposed in the consultation include whether the government’s proposal not to extend the scope of the safety features requirements or require a reimbursement number identifying the medicinal product is valid; whether manufacturers should be allowed to include information other than the unique identifier in the 2D data matrix code.

It also asks whether respondents agree with provisions requiring wholesalers to verify and decommission medicinal products bearing the safety features before supplying them to any Article 23 providers (i.e. dental practitioners, opticians, paramedics, nursing homes etc – but not community and hospital pharmacies). That’s one of the main areas of flexibility permitted under the safety feature delegated regulation.

You can find the document here: A Consultation on implementing ‘safety features’ under the Falsified Medicines Directive. Responses can be sent by email to:

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