MHRA reiterates clinical trial and medicines guidance in event of no deal Brexit
The MHRA has reiterated guidance that it has previously given regarding the regulations of medicines if the UK leaves the European Union without a deal.
The UK is due to withdraw from the bloc on 31st October unless a further extension is passed by Parliament and granted by the EU.
The agency has stated that transitional legislation will ensure that all currently granted Centrally Authorised Products (CAPs) will automatically become UK marketing authorisations (MAs) when Brexit takes place.
It’s expected the UK will align with the EU’s new clinical trial regulations when it takes place, but plans to have its own public database to provide UK patients and researchers a single reference point for UK-based trials.
There may be cases when companies have to provide more information to the MHRA for their products to stay on the market in the UK.
In August, the MHRA published its updated guidance on substantial amendments to a clinical trial in the event of no deal.
The guidance reads: “No amendment is required where the sponsor or legal representative for an ongoing trial is established in the EU/EEA as the UK will continue to accept this.
“No amendment will need to be submitted in the UK if the sponsor retains the UK legal representative for the UK study. Similarly, no amendment will need to be submitted in the UK if a sponsor remains in the UK and a legal representative is added to cover EU/EEA sites.”
You can read the full MHRA guidance, here.