The responsibility for regulating medicines destined for Northern Ireland passed from the EU to the UK yesterday (1 January).
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) will take full ownership for licensing and approving human medicines in both Great Britain and Northern Ireland, the BBC reports.
The shift was made possible under the post-Brexit Windsor Framework, which was agreed to in 2023 and succeeded the Northern Ireland Protocol. Both arrangements effectively keep Northern Ireland within the EU’s single market, while also avoiding the introduction of border measures between Great Britain and Northern Ireland.
New measures
In order to be eligible for sale in Northern Ireland with reduced compliance measures, medicines produced for the Northern Irish market must include a “UK only” label, mirroring the recently dropped plans to introduce “Not for EU” labelling on Northern Irish-bound food.
Medicines produced for UK markets must only be sold in the UK and cannot be made available in Ireland or elsewhere in the EU.
With these requirements met, medicines will no longer require features specified under the EU Falsified Medicines Directive (FMD), including 2D barcodes and serialisation numbers compliant with the EU FMD Directive.
Labelling
Labelling issues have been raised repeatedly since the Windsor Framework’s implementation, with both food producers and consumers voicing concerns about the “Not for EU” labelling plans prior to their cancellation.
Many shoppers perceived the “Not for EU” labels to reflect lower UK food standards, while manufacturers expressed concerns about the additional resource required to add the new label to only their NI-bound products.
Similar concerns were raised by the British Generic Manufacturers Association (BGMA) last year, which warned that not all medicine manufacturers would be prepared to add labels from 1 January.
Speaking to the BBC in October, BGMA chief executive Mark Samuels said the rollout required manufacturers to “change packaging across all their lines in a very short space of time”.
“Many generic companies have hundreds if not thousands of lines and the regulatory adjustment to manufacturing runs at scale is long and is a time-intensive process, typically taking six months.”
Fluorinated gas declarations
In another change to Northern Irish customs requirements, HMRC’S Joint Customs Advisory Committee (JCCC) published a notice to British exporters moving products containing fluorinated gas to Northern Ireland.
The notice highlights EU advice on changes to fluorinated gas measures in the Northern Ireland Tariff which came into force yesterday (1 January).
The gas, which contributes to global warming, is often used in refrigeration and air conditioning equipment, as well as in solvents used for cleaning in specialist industries, such as electronics. The UK government has set targets to reduce the use of hydrofluorocarbons (HFCs) by 79% by 2030.
As of 1 January, British exporters must now include new document codes in Northern Ireland declarations for products that contain fluorinated gas or that could potentially contain it. The notice adds:
“Some products that do not contain fluorinated gas may be impacted as they may be expected to complete a document code as a positive declaration that they do not contain fluorinated gas.”
Pre-lodged declarations with the new codes for goods moving after 1 January will need to be amended before the goods arrive.