Deadline looms for post-Brexit label changes for UK meds

The UK medicines regulator has reminded pharma companies that from 1st January next year, all medicines sold in the country will have to comply with new labelling measures resulting from the UK's exit from the EU.

The headline change is that all medicines sold into the UK market must have a label or sticker saying "UK Only" to show they should not be sold in EU markets.

The changes have come about as a result of the Windsor Framework, which returns overall responsibility for medicines across the whole of the UK to the Medicines and Healthcare products Regulatory Agency (MHRA) for the first time since Brexit.

Since then, MHRA has been limited to regulating medicines in Great Britain (England, Scotland, and Wales) only – with the EMA retaining jurisdiction in Northern Ireland – as a consequence of the Brexit deal between the UK and EU and an effort to avoid a land border within Ireland.

The Northern Ireland Protocol (NIP) that kept NI within the EU pharma regulatory system was widely derided for failing to resolve disparities between the EU and GB pharma regulatory environment, adding to the complexity of moving drugs to NI that increased costs for relabelling medicines and reportedly led to some supply problems.

The Windsor Framework agreement by the previous government restored MHRA jurisdiction and means that certain EU rules – for example, the need to apply the EU's format of unique identifiers on medicine packs using 2D barcodes – will no longer apply to medicines distributed in NI.

According to MHRA's interim executive director for healthcare quality and access, Julian Beach, companies responsible for around 90% of medicines sold in the UK market have already filed to update their packaging and labelling to meet the new mandate, so it is now issuing a final call to those who have yet to do so.

"We're now on the home stretch, with just over a month before the new medicines arrangements of the Windsor Framework are put into practice, providing a solution to the supply of medicines into Northern Ireland," said Beach.

"Any companies that still need to submit updated artwork should do so as soon as possible, and ahead of releasing products on the market in the new year. If you have any difficulty in doing so, we are available to help."

Under transition rules, medicines released to the market before 1st January will still be allowed to be supplied without the new labelling until they reach their expiry date.

Once the Windsor Framework is fully in place, the MHRA will also resume responsibility for approving medicines for use in NI.

If the system breaks down and UK medicines enter the EU market – for example, through parallel trade – the European Commission has said it will unilaterally suspend the Framework and introduce checks.

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