There are now several routes to obtaining a Marketing Authorisation (MA) in the UK, Great Britain (GB – England, Scotland and Wales) or Northern Ireland (NI), which fall into 2 main camps – National and International:
What are the National routes?
Innovative Licensing and Access Procedure (ILAP) – this aims to accelerate the time to market and facilitate patient access for innovative medicines.
National Procedure (150-days) – accelerated procedure available for high-quality MAAs to market a medicine in the UK, GB or NI.
Rolling review – permits the submission of your application in module(s), to obtain a MA in the UK, GB and NI.
EC Decision Reliance Procedure (67-day procedure) – For products under evaluation or approved in the EU centralised procedure, GB may rely on decisions taken by the European Commission (EC) when considering the approval of new MAs.
MR/DC Reliance Procedure (67-day procedure) – MHRA may have regard to MAs approved through European decentralised procedures (DCPs) and mutual recognition procedures (MRPs), with a view to granting a MA in the UK or GB.
Unfettered Access from Northern Ireland (a 67-day procedure) – applicants may seek recognition in GB of a MA approved in NI under certain qualifying conditions.
What about International routes (collaborative procedures)?
The Access consortium – to market a medicine in two or more of the following: UK, Australia, Canada, Singapore and/or Switzerland.
Project Orbis – a programme involving the regulatory authorities of the USA, Australia, Canada, the UK, Singapore, Switzerland and Brazil to review and approve promising cancer treatments.
In addition to the above procedures, Northern Ireland may be included in DCP or MRP as a Concerned Member State (CMS) and MAs approved in the EU centralised procedure will automatically have effect in Northern Ireland.
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