Rapid Approval of PI Products

Synopsis

In it’s drive to reduce assessment times for submissions, MHRA is requiring better quality submissions and reducing the opportunity to correct errors. From January 2024 Parallel Import licence variations were only allowed one RFI cycle and from summer 2024 new MA applications for Established Medicines were also limited to a single RFI cycle. It seems inevitable that applications for new PI licences will soon only be allowed one RFI cycle. 

This presentation will highlight less obvious aspects of the application which can cause problems and highlight probably the only up to date and comprehensive guide to the UK PI process.