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Multi-product APS

Scheduled Pinned Locked Moved PAAB Code
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  • G Offline
    G Offline
    GMC
    wrote on last edited by
    #1

    Rather than having a PSP enrolment form for each product, can we combine multiple products into the same enrolment form given that it is the same PSP vendor that manages the program?

    Jennifer CarrollJ 1 Reply Last reply
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    • G GMC

      Rather than having a PSP enrolment form for each product, can we combine multiple products into the same enrolment form given that it is the same PSP vendor that manages the program?

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hey @tmcm

      This would be a review specific question. There are examples where this could be done (e.g. unbranded patient support program) and examples where this could not (e.g. brand specific support programs which directly/indirectly allude to therapeutic use (e.g. require selection of patient characteristics which could identify the therapeutic use and suggest off-label use for other products in the program which do not possess the same indication; linking therapeutic use to products which a patient has not been prescribed also contravenes DTCA regulations [Section C.01.044 of the Food and Drugs Act and Regulations]). It would be best to submit for an opinion or full review.

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