Hilary Gray Ms

Thank you for the clarification.

In completing the online form for Initial Protocol Assistance, one question is "Has a PIP/waiver decision been granted by EMA for this product in the same or similar condition?".

However, in the auto-generated application form, the question becomes "Has a PIP/waiver application been submitted to EMA/PDCO for this product in the same or a related condition?"

These are two different questions with two different answers.  Please could anyone advise on what the intent of the question is, and what information is needed?  Thank you.