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  4. There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?
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There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?

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  • J Offline
    J Offline
    Jeff Kent
    wrote on last edited by
    #1

    Currently most Cannabis companies do not have the clinical results to support making product claims. Assuming that some of the hundreds of clinical programs are successful and Cannabis companies start making claims, will they be required to submit their APS's to PAAB?

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

      Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids).

      However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance.

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      • J Offline
        J Offline
        Jeff Kent
        wrote on last edited by
        #3

        @Jennifer-Carroll said in There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?:

        Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids).
        However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance.

        Thanks Jennifer - this is very informative. We will share this with our customers.

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