Module232025

07/05/2025

Is a PIP or PIP waiver needed?

Yes

No

Does the company already hold an MA for the active substance?

Is it still protected by patent or SPC?

No

Yes

What is the legal basis for the future MAA?

Article 10, 10a, 13-16 or 16a-16i

No further action

Articles 8(3) or 10b

Yes

Is there an applicable class waiver?

No

Yes

Can a product-specific waiver be justified?

Prepare a product specific waiver

No

A PIP is required

The Organisation for Professionals in Regulatory Affairs

19

Article 16

Paediatric Investigation Plan

• EMA position on PIP submission timing: • Not justified to start a phase 3 trial in any population before submitting a PIP application • Not justified to start any clinical trial in children before submitting a PIP application • Very difficult to reconcile this with the legal text: • No reference to initiation of phase 3 trials in the law • No requirement to have an agreed PIP before studying children in the law • Submitting a PIP isn’t a recognised regulatory milestone anyway

The Organisation for Professionals in Regulatory Affairs

20