Posted Fri, 16 Jul 2021 11:05:23 GMT by Hilary Gray Ms
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.
Posted Thu, 22 Jul 2021 07:43:18 GMT by Paolo Tomasi EMA
This is an error in the text of the generated application form. Please ignore it, the correct question to be answered is the one in the web form. 
 
Posted Fri, 23 Jul 2021 11:09:09 GMT by Hilary Gray Ms

Thank you for the clarification.

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