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  • 1.  Special Access Programs in Canada

    This message was posted by a user wishing to remain anonymous
    Posted 08-Aug-2018 09:56
    This message was posted by a user wishing to remain anonymous

    ​​Hi all,

    Does anyone have experience working with Special Access Programs in Canada?

    I have a lot of questions regarding logistics from the manufacturer's perspective (e.g. importation, labeling requirements, including restrictions for use such as specialized training). It seems like the only way to get answers from Health Canada is after a healthcare provider submits a SAP request.

    I sincerely appreciate your help!


  • 2.  RE: Special Access Programs in Canada

    Posted 09-Aug-2018 08:43
    I have found the guidance document to be pretty comprehensive and workable without prior instruction from HC.  Once HC approves the SAR, shipping the product to the practitioner is straightforward and I have not experienced any problems.  Labeling is the same as you would for a clinical study.

    Guidance Document for Industry and Practitioners - Special Access Programme for Drugs - Canada.ca
    Canada remove preview
    Guidance Document for Industry and Practitioners - Special Access Programme for Drugs - Canada.ca
    2008 Health Canada document which provides guidance on access to unauthorized drugs through the SAP (Special Access Programme) and clarifies the mandate, intent and scope of the Programme.
    View this on Canada >


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    Glen Park
    Jersey City NJ
    United States
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    Original Message


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