PAAB CODE
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References cited in the APS must be available to health professionals on request, in English and/or French, either in their original form or translated.
Data on file must be made available to the Commissioner and may be classified as ‘Confidential’ by the advertiser or the author (pending publication).
A copy of the summary of the Data on File must be provided to health professionals upon request.
Copies of all reference sources cited in an APS must be provided to the PAAB Commissioner for verification of claims and/or quotes.
Reference lists and study parameters may be moved to a web link destination. Click here for examples.
A prominent statement within the main advertising message must identify that this content can be accessed at the web link destination. The linkage mechanism may be a URL (for example in a print tool) or an electronic link. The URL may be supplemented, but not replaced, by an electronic coding system (e.g. a QR code or a bar code).
The reference list and study parameters are assessed by PAAB during review of the corresponding APS. A separate review of the link destination webpage is not required where the contents of that page are limited to the following:
Web link destination pages having additional content (whether text or images) are required to be submitted for PAAB review as a separate APS.
Where mandated by the consumer advertising regulations, the web link destination must either be gated or de-indexed from search engines. If the site is gated, the URL or electronic link promoted in the APS must bypass the gate such that password entry is not required to access these disclosure documents. The URL and electronic link must therefore be promoted only to HCPs.
Reference citation format should be clear and complete. PAAB may require changes where there is an off label or misleading claim in the title.
When relegated to link destinations, the APS reference list and study parameters must take one of the following forms:
Different link destinations for each APS:
Single link destination common to each of this product’s APS:
The content on the destination site must be in the same official language as the APS.
The Market Authorization Holder is required to ensure that the link and the destination are maintained for the duration of the period for which traffic is sent to that link/destination or for the period of use of the “originating piece”.
Disclosure of study parameters. The claim should be accompanied by or linked to disclosure of relevant study parameters that would aid the reader in interpreting the data such as patient numbers and p-value and/ or confidence intervals (CI). This information should be in prominent type size (a minimum of 8 point on 9 point). In no circumstances would extrapolation of the claim beyond the actual conditions of the supporting studies be acceptable. Information such as study methodology, description of patient type and number, disease severity, dosage range, study sites, etc. may appear with the product information.