MHRA’s authority restored following Northern Ireland Brexit deal
The Medicines and Healthcare products Regulatory Agency (MHRA) has been limited to approving medicines in Great Britain (England, Scotland and Wales) in the wake of Brexit, with the EMA still responsible for Northern Ireland. However, it is looking likely that a new deal with the EU will restore the agency’s authority over the whole of the United Kingdom.
In the pharma sphere, the issues surrounding the Northern Ireland Protocol have led to supply issues, with Northern Ireland under a different regulatory jurisdiction from the rest of the UK. The EU last year attempted to solve this issue with legislation to maintain an uninterrupted supply of medicine between Northern Ireland and Great Britain, but this was unable to solve all of the related issues.
The new deal means the MHRA will regain control of medicine authorisation in
Northern Ireland, so EU rules will no longer apply to medicines in Northern Ireland, for example the need to apply the EU’s format of unique identifiers on medicine packets using 2D barcodes.
The Association of the British Pharmaceutical Industry (ABPI) has cautiously welcomed this deal, with the trade organisation’s chief executive, Richard Torbett, commenting: “While we wait to see all the details, today’s agreement appears to bring a return to a single UK market for medicines, providing the permanent solution that our members have been calling for.”
Torbett warned that the industry needs an adjustment period to make these changes, and that the ABPI will need to “carefully consider the transition period for making these changes and to ensure any new guidance is clear and provided as soon as possible.”