What is the Unfettered Access Procedure (UAP)?
Applicants may seek recognition in Great Britain of a marketing authorisation (MA) approved in Northern Ireland.
The UAP is the route available for MAs approved in Northern Ireland via EU (centralised, mutual recognition or decentralised) procedures or through the national procedure, if the marketing authorisation holder is established in Northern Ireland and the product is distributed from Northern Ireland to Great Britain.
What should you include in your application for MAs granted in EU procedures?
For authorisations approved in EU procedures, applications should include the dossier as approved for marketing in Northern Ireland, accompanied by all iterations of the relevant Reference Member State (RMS) and Committee for Medicinal Products for Human Use (CHMP) assessment reports.
How long is the validation period?
The intention is that acceptable Marketing Authorisation Applications (MAAs) should be recognised by the MHRA for Great Britain (England, Scotland and Wales) within 67 days of MAA validation, unless Major Objections are identified.
How do you obtain a PL(GB) number?
Prior to submitting your application you can obtain a Product Licence (PL) (GB) number from the MHRA Portal or by emailing PLNumberAllocation@mhra.gov.uk
If you would like to discuss how Fusion Pharma can support you with Unfettered Access Procedure (UAP), please email us at firstname.lastname@example.org or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.