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October 18, 2022 at 10:32 am
#4766
Rebecca Siegl
Participant
Hello,
I would also classify it under Zone 06 and then under Non-IP Documentation. A Non-IP is per definition ‘a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial.’ So in my opinion this section is the closest we can get to a suitable place for AxMP in the TMF.