Schedule 2 products, DTC, and linkage oh my!
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Hi, I have a question regarding schedule 2 (nonprescription, but regulated by Heath Canada) products, specifically a biologic. Is it permissible to link from a DTC site (ungated) to the complete, unedited product monograph? Also, does the 2023 Guidance on the distinction between advertising and other activity, which now specifically mentions biologics, affect the review of this type of product?
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Hi, I have a question regarding schedule 2 (nonprescription, but regulated by Heath Canada) products, specifically a biologic. Is it permissible to link from a DTC site (ungated) to the complete, unedited product monograph? Also, does the 2023 Guidance on the distinction between advertising and other activity, which now specifically mentions biologics, affect the review of this type of product?
Hello. As the example does not specify the product, we are unable to answer the question directly. The product, therapeutic area and Health Canada product schedule will determine which regulations apply in the DTC space. We direct you to the Food and Drugs regulations and the document Guidance Document: Schedule A and Section 3 to the Food and Drugs Act. It will provide clarification on advertising restrictions to the general public. Please note section 3 and 2.3 of the document regarding Schedule A diseases in advertising. Linking a DTC website even to an unedited PM may be a violation of the regulations depending on the therapeutic area. We suggest contacting PAAB for a general question call should you need further clarification. Please also note that the DTC site is considered promotional advertising so the Distinction document does not apply in this scenario.
