Snapshot

The Unfettered Access Procedure (UAP) pathway has been developed by the of United Kingdom.

This pathway can be used where All medicinal products approved in Northern Ireland via European procedures (centralised, mutual recognition or decentralised procedures) or via the Northern Ireland National route are eligible..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from EU-EMA Europe Ireland

All applications will be assessed to ensure they comply with UK regulatory requirements, including those related to: Great Britain Reference Medicinal Products, product name, labelling, patient information legibility, supply status, controlled drug scheduling where necessary, paediatric and orphan medicine requirements, where relevant. The first round of assessment should be completed by Day 42. It is anticipated that the vast majority of Great Britain marketing authorisations (MAs) will be approved at this point. Any issues identified during assessment will be communicated and should be resolvable within the 67-day timetable without clock-stop.