Spring Intro 2023

16/02/2023

PIPs – A word about UK

• EU PIPs are not valid in UK as a result of Brexit

• A separate UK PIP submission required

• The same principles apply to both EU and UK PIPs

• The same timetable applies to both EU and UK PIPs

• UK has its own PIP templates…

• …so extensive cutting and pasting is required

The Organisation for Professionals in Regulatory Affairs

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PIPs – important things to remember

It’s not only about clinical aspects:

• Dosage form / formulation are very important • Studies in juvenile animals may also play an important role • Modelling and extrapolation are increasingly widely used

If the drug fails in children, you still collect the incentives

• Adhere to PIP • Propose appropriate SmPC text • Collect the incentives

Paediatric studies are ethically and practically difficult

Make appropriate use of waivers, deferrals, modelling and extrapolation

Your MA application will not be valid unless you have an agreed PIP (or full waiver) and are successful at PIP compliance check No PIP, no MA

The Organisation for Professionals in Regulatory Affairs

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