@lora_nolan

There may be opportunity to include the final analysis providing it meets all the requirements set forth in our Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising. As we do not have the actual TMA and published paper for review, we are unable to provide a definitive answer. We suggest submitting an opinion if you remain unclear after consulting the guidance document.

@jennifer-carroll
Okay I understand now, so saying "#1 dispensed ProteinX inhibitor for DiseaseA" would be misleading if 90% of those dispensings were really for the off-label treatment of DiseaseB? Yep, that makes sense, thank you!

@healthymind

The Health Canada Distinction between advertising and other activities document is separate from the PAAB code which is for advertising directed to health care professionals and patients as per Code Section 1.3B. Code section 7.5 provides guidance for editorial advertising/promotion systems (APS) and states that it should be clearly identified as advertising to distinguish from other editorial presentations; hence, this requires that the manufacturer’s name be included in unbranded editorial APS. Note that code section 1.4K.A. also provides direction for digital media for various content including unbranded information and indicates that the pharmaceutical company sponsor should be clearly stated in the advertising.

@jennifer-carroll Thank you for the clarification, Jennifer!

Hi @amyl

We missed this question and sincerely apologize for the delay in responding!

Yes, they may be submitted as a series. Series files are usually submitted together on the same day. Please see our submission guidance document for series submissions.

Hi @gmc

We have reviewed such sites. In general, the URL for the website (brand.ca) is to the homepage where gating can be started with the DIN number for the patient to enter. Once the patient is in the site, part 3 of the Product Monograph will dictate whether patients can see other therapeutic areas/ indications, i.e. is there only one part 3 for all indications or separate part 3s for separate indications? (we refer you to Section 1.1b of the Guidance on Branded Patient Information). If they are separate part 3's, then one suggestion is for the site to offer an option for the patient to enter their indication in order to enter the appropriate section.

@jennifer-carroll Thanks so much!!

@carbonad

We are unable to provide reviews for acceptability on proposed claims or APS on PAAB Forum as this is for general queries. The formal review process will assess the indication and respective formularies to determine acceptability of a claim, i.e. alignment of potential criteria with the indication. For your consideration, there is an option to submit an opinion request with all the relevant PM and formulary support if that is preferred over a complete preclearance review.

For the claim noted, in general, inclusion of the indication and a coverage claim would require inclusion of appropriate fair balance, disclosure of the provinces that are providing coverage and if special authorization or criteria are required. Please note that RAMQ has specific requirements for provincial coverage claims. For referencing requirements, the latter format is acceptable.

As space is a noted concern, if geo-targeting is an option, the message could be limited only to “Now on provincial formulary (special authorization may apply)” and be only served on browsers known to be in one of the covered provinces. Please see the following resource for formulary claims including RAMQ requirements, PAAB : Resources : Advisory - Provincial Formulary Coverage Statements.

@stet

An unbranded APS may be created for physiology or pathophysiology of the signaling pathway. However, the APS may not make reference to potential treatment or exogenous intervention at the target site as that would brand the APS if there are no other agents that work at that target.

Hello @username

Please see Q&A 647 .

Hey @username

The brochure should be submitted as a reference for PAAB to assess. If there is content within the brochure which would not be acceptable in the context of linkage to the brand, the link will not be allowed. At that time, you’ll have the option to submit it for full review/revision to be an acceptable link or remove the link.

Hello @username

Let’s begin by setting a common understanding of what is market research (and what isn’t market research).

Market research has the sole purpose of pointing out and defining marketing opportunities and issues; generating, refining, and evaluating marketing programs; monitoring marketing performance; identifying patient and prescriber needs and improving understanding of the marketing process. The planning, implementation, evaluation, and utilization of market research should reflect that sole purpose. The activity is not considered market research if the purpose includes promotion of a health product (or the features/properties of that product). The content, its context and tone should reflect these facts as should the type and number of participants (and the nature of the agreement/contract where applicable). We invite you to refer to the “General Principles” section of the Distinction Document to determine whether the activity is potentially subject to advertising regulations (and consequently subject to PAAB preclearance if targeting HCPs). The IMC Code of Ethical Practices is an additional resource for standards/factors pertaining broadly to market research and for some specific examples of market research.

True market research is generally not considered subject to advertising regulations. And consequently, the PAAB Code standards and preclearance are not applicable. However, please note that some activities that are believed to be market research are actually promotional in nature. If there is any doubt, you are welcome to use the PAAB advisory opinion service to confirm whether any particular activity is indeed exempt from advertising regulations (see our fee schedule for more information).

Please note that communication of market research findings in advertising is subject to preclearance.