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Brexit: ‘Phased’ period agreed to implement medicines regulation in NI

ABPI: Having a phased process is “absolutely critical” for Northern Ireland
ABPI: Having a phased process is “absolutely critical” for Northern Ireland

The UK and EU have agreed a “phased process” for the implementation of medicines regulations in Northern Ireland, to give businesses time to adapt, the government has announced.

Following a meeting of the Ireland/Northern Ireland Specialised Committee last week (November 5), the Cabinet Office announced it has agreed with the European Commission to have a phased period “for implementing medicines regulation in Northern Ireland up to December 31, 2021”. 

The 12-month “phased process” following the end of the transition period will provide “additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive [FMD] requirements”, the Cabinet Office said.

The National Pharmacy Association said earlier this week (November 9) that it welcomed the announcement as “common sense”, after raising concerns last month about the lack of “robust” plans around medicines access in post-Brexit Northern Ireland.

Phased period “absolutely critical”

Speaking before the House of Commons’ Northern Ireland Affairs Committee yesterday (November 11) Dr Richard Greville, director of distribution and supply at the Association of the British Pharmaceutical Industry (ABPI), said having a phased process is “absolutely critical” for Northern Ireland.

“That flexibility of an additional 12 months for the whole of 2021 should provide sufficient time to ensure that all stakeholders can make the changes that will be required during that time”, he said.

The “devil is in the detail” but “we remain optimistic that it does give us the appropriate and sufficient time to arrange our supply chains because those supply chains will need to be changed significantly”, Dr Greville told the committee.  

Under the terms of the Northern Ireland protocol of the EU Withdrawal Agreement, pharmacies in Northern Ireland will still be required to comply with FMD after December 31 as the directive will continue to apply in the country, unlike in England, Scotland and Wales.

The FMD packaging requirements require medicine packs to bear two safety features: an anti-tampering device and a unique identifier (UI) in the form of a barcode that is registered on the European Medicines Verification System database.

Importing drugs in post-Brexit Northern Ireland

It is likely that Northern Ireland will in the future stop sourcing medicines from Great Britain and import them directly from European countries, Dr Greville said.

Medicines sourced from Great Britain may not have a UI or may have had their UI deactivated, which means they would have to be relabelled before being issued to Northern Ireland, he explained. 

But reactivating packs before transportation to Northern Ireland is a “significant extra step”, for which there is no “infrastructure currently”, Dr Greville said.

“It is perhaps more likely that in the future, Northern Ireland medicines will be shipped directly from Europe into Northern Ireland, avoiding Great Britain as a marketplace,” he added.

“In those cases, the initial medicine will not need to be decommissioned or made inactive, so when it lands in Northern Ireland it will remain active and be scannable by pharmacies to ensure verification and authenticity of that medicine,” Dr Greville said.

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