Module232025

07/05/2025

UK PIP similarities and differences

• Application form - UK template nearly identical to the old EU pdf form • Scientific document - UK template is nearly identical to the EU • Key Elements Form - UK template nearly identical to the old EU pdf form • Differences include that UK still requires a letter of intent (2 months notice needed) and cover letter - templates available on MHRA portal

The Organisation for Professionals in Regulatory Affairs

PIP Development

25

Mentimeter multiple choice question:

Have you ever used IRIS? • No • I have an EMA account but not used IRIS • Yes, but haven’t used it much • Yes, but I don’t feel confident using it • Yes, I’ve used it on multiple occasions

The Organisation for Professionals in Regulatory Affairs

PIP Development

26