Good Afternoon @aboucouvalas

It’s important to note that the naming convention mentioned above is to allow for pieces to be attached to a standardized email template and therefore will not have the indication and appropriate level of fair balance associated with it. If you wish to send an email with three different patient information tools for one brand across three indications, it may be worth considering a branded email. At this point, the email could contain the appropriate level of fair balance and allow for the identification of the therapeutic area within the naming convention. Note that should you take this route, the name of all attached tools should be included in the email submission.

Hello @healthymind

By October 1, 2021, the vast majority of APS in the market place will bear the new logo. Although this date will mark the end of our 1-year transition period, it is understood that straight renewals (pieces with absolutely no changes) bearing the old logo will continue to be disseminated / distributed until stock is depleted. Our expectation is that, upon reprinting, the logo change will be implemented. With the understanding that the updated logo will adhere to our style guide, this change does not trigger a need for resubmission. To be clear, at no point are manufacturers expected to destroy old stock on account of the logo change.

Hey @afpjjim

The principle to consider is in the “Dissemination” section of the document referenced. The copy reads “If the intent is for the email template to be used across many brands (and therefore not contain fair balance), the document naming convention should not trigger the addition of fair balance. This means that it should not contain claims or copy that links the brand to therapeutic use.” If the brand name appears in the piece and there is a study name, this would create that link (see Attachment of clinical reprints in an RTE). During the submission process, you would define the naming convention as “Study acronym_study_safety_data” and convey that studies across multiple brands could be attached in the same email. The reviewer would assess if indication and fair balance are required.

@Jennifer-Carroll I've solicited feedback from ANTIBODY's Creative Director, Melisa Barrilli, who had the following thoughts to offer on the bilingual logo:

Although we rarely use bilingual logos, they do come in handy. Glad a version was created! The bilingual logo seems to have optimized the space and flows well. Legibility seems excellent for the PAAB/CCPP words. It will be interesting to see how all versions look when applied at their minimum recommended size—there's considerable size variation with the smaller type, so "Reviewed by" may become illegible if used too small.

Hope this is useful!

Hi @alee

The full TMA of both Drugs A and B along with original study would be required to assess the extension study. As an example, PAAB would need to assess the TMA of drug B to determine the parameters for the 1 year restriction—Does the 1 year restriction also relate to safety or is it only that the clinical trials were one year in length? Etc. The consideration for acceptability of the extension is dependent on the pertinent information. Given the nature of the required assessment, it would be advisable to consider the PAAB’s written opinion service (refer to the fee schedule on the PAAB website).

Hey @laraholmes

It’s unclear what “in this respect” is referring to. “Open text fields” are “blank” by definition as the rep determines the copy. The restrictions for open-text fields are that the manufacturer has confirmed the reps are trained to limit open-text to transactional element with no therapeutic, product or service/tool being mentioned (see full advisory above). It may be beneficial to set up a clarification call so that we can better understand your question. Please reach out to admin to set up a call with me.

@rebeccaallen great question. The requirements behind the logo size are to ensure that aspects of the logo remain legible in use. We set minimums for smaller tools to help facilitate this practice. For larger tools such as websites, the 85px size applies as a minimum with the preference being that the logo would be scaled up appropriately for larger tools. This means that a mobile webpage would likely still be appropriately 85px however a desktop could be increased to improve legibility and promote the sponsors willingness to participate in the independent review process.

@jennifer-carroll I will do that. Thank you for your help!

@jennifer-carroll that makes sense, thank you for clarifying!

Hey @kshulist

An image that supports the evidence presented in the piece from an RCT, would be considered acceptable even if it was from a patient in an RWE trial. PAAB does not request confirmation that it is from a patient in the trial being presented who had the average response. The visual simply needs to reflect what would commonly be seen as “consistent with” the magnitude of effect demonstrated in the RCT.

If the evidentiary basis of support is the RWE, use of the images would not be acceptable.

Hey @justineeve

Please see code section 1.5E.

Good morning @la_01

No. You cannot link branded to unbranded in any manner. This is not limited to just the look and feel of the piece. Connecting through clicks is still a link and is not acceptable. All spaces would have to be reviewed in the context of the brand. This means, that while they may not have brand mention, the link requires the content on them to not exceed what is allowable in the context of the brand.

@abyscat

“The formulary status for Drug XYA has been updated” may potentially be exempt depending on the context in which it is presented. Our PAAB opinion service is available for exempt opinions.

Hey @taylor-murphy

Please note that the guidance you are referring to states “Launch materials for products approved via Health Canada’s “Interim Order” or their “Accelerated/Priority Review” not “in priority review”. The submission guidance is for approved products. This means Health Canada has granted market authorization with a finalized TMA. Pre-NOC is based on a draft document. The eFile system does not programmatically screen the APS types. This is why the form lists the APS types that are applicable to ARO (i.e., to minimize delays that occur when our admin team needs to return submissions for adjustments).

Furthermore, please note that the first sentence of the previously referenced document clearly outlines PAABs mandate: “The PAAB mandate is to review advertising and promotional systems (APS) for approved pharmaceutical products.”. It also goes on to state “However, PAAB recognizes the importance of product launch timelines, and in this guideline, clarifies procedures for advertising review before Notice of Compliance (NOC) has been granted.” and “PAAB will accommodate pre-NOC submissions at the discretion of the PAAB Commissioner with respect to workload at the time of submission, and will not be subject to the standard turnaround time”.

The pre-NOC policy and the ARO pilot are both manifestations of our commitment to ensuring HCPs and patients receive timely information about therapies. It is important to avoid expediting reviews for materials that cannot be used in the marketplace (as the product is unapproved) at the cost of delaying the review of materials that could be immediately used in the marketplace.

Hello @dmauri

PAAB practice has been to accept communications from formulary bodies to the manufacturer which confirm listing and criteria in the absence of published coverage criteria. In the absence of these letters, we have accepted an attestation from the sponsor that confirms the EAP listing and that the government/ministry has no objection to the marketing of this criteria. The client can proceed with submitting pieces which communicate the listing and criteria.

@jennifer-carroll Thank you for the quick response!

@jennifer-carroll Thank you for clarifying these points. Highly appreciated.

Good morning @mef

Only those parts of the website which are restricted to registrants of the conference could be considered part of the “confines”. This is not a blanket “yes”. If content is added to the site post the conference, or users are pushed to the content through other channels, it may not be considered part of the conference. It may be beneficial to submit for an opinion so that you can provide more details.

Hey @constance

Always happy to have more examples to discuss. If you’d like to send examples for the group to discuss, please email them to me at jenniferc@paab.ca.

What we would require is:
• Confirmation from the sponsor that the content can be discussed and shared with the committee
• Confirmation from the sponsor that all content discussed can be shared externally as part of training documents
• Any information you can share about the campaign such as “what are the primary and secondary messages the campaign hopes to convey”
• If the creative went through iterations, provide the iterations (iterations with PAAB or outside of PAAB such as through the internal Canadianization process or within the agency).
• If you have internally developed creative that was not part of a sponsor project that you think would make for good discussions, we can look at those as well

The committee will not be evaluating the merits of any past decisions or evidence and in most cases the discussions will be brand agnostic so that the discussion stays focused on assessing creative elements.

As the committee is meeting in early January, we'd encourage sending content before then. 🙂

Hello @Manufacturer and @Agency .

Please find uploaded the completed Tag report and CEI report for Q4 of 2023. Please let us know if you have any questions.

Have a great week.