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  4. Treatment Options within an Unbranded asset
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Treatment Options within an Unbranded asset

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • A Offline
    A Offline
    AP
    wrote on last edited by
    #1

    Within an unbranded asset, if we are mentioning different treatment options/replacement therapies not by drug name but by outlining different treatment formulations and each formulation happens to have only one product out in the market, would this be allowed.
    Also, if we talk about the treatment formulations, can the Product Monograph be used as a reference?

    Jennifer CarrollJ 1 Reply Last reply
    0
    • A AP

      Within an unbranded asset, if we are mentioning different treatment options/replacement therapies not by drug name but by outlining different treatment formulations and each formulation happens to have only one product out in the market, would this be allowed.
      Also, if we talk about the treatment formulations, can the Product Monograph be used as a reference?

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

      Hey @ap

      An unbranded piece that speaks to products which the patient is not on, would be considered consumer advertising. The activity above appears to fall under “Medical condition and treatment awareness material” (formerly consumer brochure) and as such would have to meet the requirements outlined in the Distinction Between Advertising and Other Activities document under section “Medical condition and treatment awareness materials”. This outlines that all options must be included (pharmacological and non-pharmacological).

      The Product Monograph can be used as a reference for treatment formulation but would not support direct or implied comparative claims. The reference should not be listed in the piece as this would create a link between the brand and therapeutic use which is in violation of the Food and Drug Regulations.

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