Navigation

    Forum

    • Register
    • Login
    • Search
    • Categories
    • Recent
    • Popular
    • Users
    • Groups

    Multi-product APS

    PAAB Code
    2
    2
    109
    Loading More Posts
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes
    Reply
    • Reply as topic
    Log in to reply
    This topic has been deleted. Only users with topic management privileges can see it.
    • G
      GMC last edited by

      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 Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @GMC last edited by

        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.

        1 Reply Last reply Reply Quote 0
        • First post
          Last post