Posted Mon, 19 Oct 2020 15:05:34 GMT by Pauline Leslie Dr
I am completing a Scientific Advice request for a product which received a PIP waiver in July 202.

Under Procedural Information > Paediatric Investigation Plan information, after "yes" is answered, then when clicking the search button to look for the appropriate waiver, the box is empty with "There are no records to display".

Should this be linked to the RPI and therefore be available for all PIP opinions issued associated with the same RPI? How do we resolve for a current Scientific Advice request if the PIP opinion is not linked in this way in IRIS?
 
Posted Mon, 19 Oct 2020 15:51:56 GMT by Paolo Tomasi EMA
The search box for PIP opinions/decisions contains the complete list of all PIP opinions/decisions, as these is public information. In addition this allows to choose any PIP, even if granted to a different applicant, which is in relation with the Scientific Advice submission. You need to search for the correct PIP decision or opinion, by searching for the appropriate PIP number or EMA decision number - either is fine as in principle both are included in the list. 
Posted Tue, 20 Oct 2020 07:49:36 GMT by Pauline Leslie Dr
Thank you for the reply.

I think there is an issue with this functionality, because there are no search results returned when entering a PIP number or EMA decision number, even if I try with different numbers (related and unrelated to the current application).
Posted Wed, 21 Oct 2020 08:17:23 GMT by Paolo Tomasi EMA
Please raise a ticket with EMA Servicedesk, mentioning the PIP number you are trying to retrieve, and your draft submission number. Please attach screenshots displaying what you do. 

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