GCP Inspection fees/PO in IRIS

Isha Arora
Posted Tue, 10 May 2022 09:13:40 GMT by Isha Arora Dr.
Hi,
According to IRIS Guide of applicants, "Upon adoption of a GCP inspection, [...] you must update the submission with the necessary information (i.e. Purchase Order (PO) number and requested documents) within 10 working days of the inspection announcement".
  1. In regards to PO number, can it be the study sponsor PO number ?
  2. Can you confirm it does not have to be the MAH PO number ? (in which case it does not even make sense to ask for it)
I would appreciate your prompt reply please as it could significantly impact the way our internal organisation for fees payment is setup.
Best Regards,
Isha
Answer
Dunja Vukic
Posted Fri, 13 May 2022 15:11:51 GMT by Dunja Vukic
Dear Isha,<br> <br> The industry submissions for inspections are only accessible to Applicants/MAHs and fees are therefore charged only to Applicants/MAHs.<br> IRIS has not affected the way EMA works with fees for inspections and PO numbers.&nbsp;<br> <br> Kind regards,<br> Dunja

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