Hi @ramy

The original question was for an exempt APS and if there was an issuing linking to the PM. If it was linked to the PM, the ad is no longer considered exempt. As a PAAB reviewable APS, we likely would not object. The answer remains the same when applied to the scenario presented, i.e. the exempt APS is no longer exempt when it links to post gate PAAB approved content. However, as a PAAB reviewable APS, we may not object to this linkage if the content is acceptable.

Hello @danielle

Firstly, I apologize for the delay in response as I was on vacation. We’ll look to modify internal processes for the future.

An HCP reminder ad in a gated space, limited to the indication, brand colors and logo with no creative/visuals, would prompt the inclusion of the lowest level fair balance regardless of the black box warning. There are no additional requirements for lowest level fair balance for products with black box warnings.

Be careful, as the question above is about DTC. As noted in the response, “reminder ads” in the DTC space are limited to “name, price, quantity” (no reminder ads are permitted for controlled products). If the ad is going to appear in an ungated space, it should not contain the indication or allude to therapeutic use.

@lags

The “no objection” number has an expiry date because product monographs may change, new products come to market and some Health Canada regulations are in a state of transition. What may be in line with regulations today may not be necessarily true in the future. The renewal/re-submission process helps ensure that previously reviewed ads continue to meet regulations.

Hello @jd

Yes, it is acceptable to inform HCPs of a DTCI campaign. The communication would be subject to the PAAB code and should be clear that it is consumer information or advertising. The inclusion of the manufacturers name would be required. The communication of the DTCI campaign does not automatically render the DTCI campaign subject to review by PAAB, though the content should be submitted with the review of the HCP communications so that PAAB may ensure that the totality of the message is acceptable. As one example, it would not be acceptable to tie a brand to the DTCI campaign for the HCP if the content within the DTCI campaign went beyond what would be allowable for the brand.

Good morning @georgian21

As per the Services page on the PAAB website, PAAB’s goal is to provide a first response for all DTC pieces within 4-days. If the piece has a secondary audience of patients or HCPs, it will be subject to the 10-day turn around.

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Hey @username

An image of the device may still suggest its route of administration and therefore may not be acceptable. The proposed home setting would also have to be assessed to determine if it fully aligns with the complete administration instructions from the TMA. Based on the nuances of the image and variables needed for proper assessment, it may be beneficial to submit for an opinion prior to creating the full campaign.

@kshulist
Yes, two brands can share a landing page. It does not matter regarding the indications as they should not appear on the pre-gate portion of the website as per the Food and Drugs regulations, C01.044. The regulation does not permit advertising of prescription medications to the general public beyond name, price and quantity. The content on the page should also meet this regulation.

Happy Friday @tmcd

Health Canada recognizes both ASC and PAAB as bodies who can provide advisory opinions on information directed to consumers (DTC) on educational material discussing a medical condition/disease (see HC link).

Should the context of the piece change through distribution or additional linkages, the audience may no longer be restricted to just consumers. If this is the case, we must assess the new context and audience. As an example, pieces which will be provided to HCPs (e.g., for distribution to their patients), now requires review for adherence to the standards of the PAAB code as per section 1.3 (The scope of the Code of Advertising Acceptance applies to all Advertising/Promotion Systems in both official languages of Canada (English and French) distributed via all media to healthcare professionals and patients) even if they have been reviewed by another preclearance agency.

When HCPs are simply informed of DTC campaigns, the PAAB asks to see (not review) the DTC piece to ensure the linkage between the two assets (e.g. DTC and APS) is permissible.

Hello @Username

If the piece is truly DTCi, than yes, it would be acceptable to have mention of controlled substances. As the risks are higher with controlled substances, it is highly important to ensure that the piece truly meets the DTCi regulations and is not advertising.