I’m looking to clarify the requirements around the attestation letter for a submission. Specifically:
Does the attestation letter need to be signed by the manufacturer, or can it be signed by the company responsible for the promotion of the product?
Does the signatory need to be from the Canadian office, or can it be signed by the global team?
Thank you!
Hello! Would a brochure holder that only contains the brand logo and PSP logo be exempt from PAAB review? No claims or other content will be included. The brochure holder will hold the brands patients brochure that was approved by PAAB.
If an APS only contains the drug logo (or brand name) and the general therapeutic area (not the indication), would this necessitate the indication statement and lowest level fair balance?
For example, if a drug was indicated for psoriasis, could we have an APS with ONLY the drug's logo and a callout saying "For additional info, contact dermatology@support .ca"?
Also, per PAAB code s1.5, can you clarify that this would be exempt to PAAB review?
We are creating separate HCP and patient branded co-pay announcement APS. The content on the HCP co-pay APS is:
The content in the patient co-pay APS is:
Are the above 2 APS scenarios considered PAAB-exempt if we do not include the indication for [brand name]? If not, can you clarify what about this content subjects these APS to PAAB review?
We have an unbranded, PAAB-exempt email that contains links only to other unbranded, PAAB-exempt digital tools. Would it be permissible to include a link within this email to an unbranded, PAAB-approved tool, given that there is no way for users to navigate from the PAAB-approved tool back to the email? I understand that in the reverse scenario (a PAAB-approved email linking to a PAAB-exempt tool), the tool would be subject to PAAB review. Could you please confirm if the same applies in this case?
We are looking at purchasing digital ad space on The Canadian Journal of Psychiatry. The journal can only be accessed behind a paywall and is clearly stated as intended for HCPs. Is this a sufficient gating mechanism to have our ad reviewed as an HCP APS?
@jennifer-carroll Thanks for the clarification. How recent should the market share data be when submitting an APS to PAAB that contains a #1 dispensed claim? For example, if a #1 claim was approved on numerous pieces with expiry dates throughout the year, as each was coming up to expiry and being renewed through PAAB would we need new data for each renewal or would data from within the last 6 months be sufficient?
What are the requirements for making a #1 dispensed claim? I understand the guidance here: https://www.paab.ca/resources/paab-guidance-documents-for-market-share-claims-in-advertising-/ for making the claim but when does the product lose the ability to say they are #1? If they are not #1 for 1 month but then regain the leader position the following month what does that mean for making the claim if they remained as the leader for the last 12 months?
Also, when a product loses the #1 position, what happens to all the marketing material currently in circulation? Do they have to be pulled from the field?
What are the guidelines around saying method of admin with the brand name in a subject line/preview text of an email. For example, I understand that if we say "injection" with the brand name in the SL/PT that we need to include balance which we can't but how come for brands where their official brand name is "[brand name] I.V" that we can use that in a SL/PT without needing balance?
In what scenarios can the indications be left out of an APS?
If the only content is the drug name + branch of medicine (ex. Hematology), can indications (and balance) be omitted?
What evidence is required to say something similar to "Drug X: trusted by HCPs"?
Is a reference demonstrating that the drug is the top prescribed among the drug class enough?
