@jennifer-carroll said in 716 - Hello, I'm looking for where to find guidance regarding regulations for executing a 'help seeking' DTC campaign for vaccines at the same time as a branded DTC vaccine campaign. Given the DTC nature, pre-clearance would likely be through ASC. I've reviewed the guidance from Health Canada at length and am well aware of the criteria for help seeking. My understanding is that the help seeking and branded campaigns must be different (ie: in colour, tag lines etc) and not linked in any way, but I'm unable to find specific direction. I'd like to be more clear on how the campaigns must be different, assuming they are not linked in anyway (visually or otherwise), and if/how they may be executed concurrently. ie: can a vaccine help seeking TV ad be on during the same time a vaccines DTC branded banner ad or social media campaign is running (again, assuming not linked in any way). Thank you in advance for your assistance.: he same statement in DTCI, used in the DTCA may be considered a link depending on the balance of the APS, e.g. It is the only statement in the APS + p Thanks so much for the clarification, Jennifer!

@jennifer-carroll Thank you for your help!

Hello @llmktg Acceptability would be assessed during the review process. Linking to the homepage/cover page of the complete guidelines, is likely permissible with the understanding that they are recognized Canadian consensus guidelines. For unbranded ads, the linkage should not contravene the principles outlined in Code section 7.5. There are some scenarios where it could be challenged. As an example, if the unbranded piece speaks to a drug class for which the use is off-label in the guidelines.

Hello @andrewleeson The added clarification copy “however, linking a name-only banner ad to the TMA renders it non-exempt from preclearance as this constitutes a link to therapeutic messages” was added so as to help avoid the misinterpretation that just because there “should not be an issue linking such banner” meant that the banner remained exempt. The activity of linking the banner to a therapeutic message renders it no longer exempt. We did not believe that was clear with the initial response. We will remove 517 to help reduce confusion. Please consider the response in 330 to be accurate: “A piece containing only the message "Drug X is coming soon" with absolutely no other message (implied or stated) within the piece AND absolutely no link to therapeutic or promotional messages is exempt. Note that the manufacturer is responsible for ensuring that this message is employed only AFTER the product has been approved by Health Canada. It is prohibited to advertise a drug product prior to Health Canada approval.”

Great question @gbrl88 Question 654 is a great primer for this question. The same response applies to a HCP audience. All links must be assessed for acceptability within the context of the brand. Note that a key point for considering the link, is that the site is an authoritative independent third party site. A direct link to off-label content would not be acceptable even in the presence of a second gating mechanism.