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  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. PSP Enrolment Form Review Requirements
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PSP Enrolment Form Review Requirements

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • M Offline
    M Offline
    MedWriter
    wrote on last edited by
    #1

    We’re hoping to clarify whether PSP enrolment forms always require PAAB review. Is there any situation where these forms wouldn’t require review?

    Since enrolment forms typically don’t include claims, we’re wondering if the content could be simplified or limited in a way that might exempt them from review.

    We’d greatly appreciate your guidance to ensure we’re approaching this correctly.

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

      Hello @medwriter

      Exemption criteria can be found in PAAB Code section 1.5. There are many factors that can render a PSP enrolment form subject to advertising regulations. Some examples include specific copy on the enrolment form, mention of therapeutic use, distribution, linked content (all forms of linkage), PSP program name, imagery, etc. This is not an exhaustive list.

      In general, if it is going to a patient through an HCP and it is a company created/sponsored PSP, it is subject to review. The activity is promoting enrolment in a company sponsored program for which they have a vested interest. See Code Section 7.4. The review process ensures no unintentional promotions or messaging outside the regulations.

      M 1 Reply Last reply
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      • Jennifer CarrollJ Jennifer Carroll

        Hello @medwriter

        Exemption criteria can be found in PAAB Code section 1.5. There are many factors that can render a PSP enrolment form subject to advertising regulations. Some examples include specific copy on the enrolment form, mention of therapeutic use, distribution, linked content (all forms of linkage), PSP program name, imagery, etc. This is not an exhaustive list.

        In general, if it is going to a patient through an HCP and it is a company created/sponsored PSP, it is subject to review. The activity is promoting enrolment in a company sponsored program for which they have a vested interest. See Code Section 7.4. The review process ensures no unintentional promotions or messaging outside the regulations.

        M Offline
        M Offline
        MedWriter
        wrote on last edited by
        #3

        @jennifer-carroll Thank you kindly for the clarification - this is helpful.

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