Hi @jennifer-thomson

Linking a message to an email signature used by Brand Managers has the potential to have implications for the product/brand, so it would depend on what the actual “commitment message” is. The following are just general principles to consider for different target audiences:

When directed at a non-HCP audience, Brand Manager sign-offs should meet the applicable DTCA regulations (e.g., name/price/quantity for Rx and no mention if narcotic or controlled substance, for the totality of the message in the communication).

With respect to HCP communications, the PAAB Code should be considered. Code section 1.5E states that to be considered an exempt corporate message there should be no product mention. In addition to product mention, “commitment message” is vague and could easily become problematic. This type of addition to signatures would likely render the piece reviewable. Additionally, note that a 1:1 communication is exempt on the predication that the user has requested the information in an unsolicited manner and that the information being provided is done to address the specific request, not to provide additional unsolicited content (e.g. “commitment message”)

We would also question brand managers messaging patients and note that patient information cannot be promotional in nature.

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.

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.

Hi @nhem

The entirety of 7.4 states:

Corporate Advertising / Promotion Systems (APS) These are designed to create and maintain a favorable image of a company, its products and its services. See Section 1.5: Materials Not Subject to PAAB Review. These systems may be used at any time at the discretion of the advertiser but must be submitted for PAAB preclearance prior to publication. They must not contain therapeutic or other claims of product merit or status. They may contain:

1. A general statement about the pharmaceutical company, its products and its service(s) and policies.

2. A partial or complete list or illustration of products manufactured and/ or distributed by the company, along with their respective therapeutic or pharmacologic classifications

3. Product information does not have to accompany corporate advertising.

This therefore conveys that corporate messages which do not contain product information or product lists (direct or indirect) are exempt per 1.5. The remaining scope of corporate advertising is subject to review per 7.4. As an example:

“Company X employs 2000 Canadians” is a corporate message that does not speak to products or product lists. This message (as a stand-alone message), would be considered exempt.

“Company X is the proud manufacture of Product Y” is a corporate message that contains product information. This APS would be subject to review.

“Company X is dedicated to research in the treatment of condition Y” would be subject to preclearance as it alludes to products when it states “treatment”.

The copy “Product information does not have to accompany corporate advertising” refers to the fact that corporate messages may make mention of products, but do not require the fair balance or TMA link if they meet the spirit of a corporate message and are not brand promotions.

@cchristopoulos

In general, PAAB should be informed of all changes to an APS post approval, including re-directs for a QR code as it would deviate from what was approved. While the re-direct would be a PAAB approved branded APS, the context of the original message in relation to the new APS is a consideration. It can be forwarded to PAAB as an FYI initially and we can determine whether that is sufficient or if an update would be required.

@palanski @Jennifer-Carroll Thank you!

Hey @ey

Please see Q&A 650.

Hey @charlton

Please send the requested revision in as an FYI and we will assess if it meets the spirit of an FYI request.

@eyim

The types of messages listed in section D are exhaustive. However, it is not exhaustive of how the principles might be demonstrated in a specific APS. We offer our opinion services if a company is unsure if an APS meets exemption criteria.

Please reach our to our admin team at review@paab.ca should you require assistance with this service.

Hello @jd

Given the scenario above, the reprint carrier would be subject to PAAB review as distribution of a reprint carrier qualifies as an advertising/promotions system (APS). The tool is likely subject to lowest level fair balance requirements.

HI @keoca

This would be considered a service-oriented vehicle and would be subject to review as it is part of the HCP-patient interaction in the context of the brand. It could likely be submitted as one file.

Hey @stanley, sorry for the late response, this one must have slipped through the cracks.

S.1.5 is not considered to be an exhaustive list. The copy “X is back in stock” would be viewed as a commercial availability message. If it was not linked to any other messaging, it could be considered exempt.

You are correct, the addition of the indication statement would create a link to the therapeutic use and prompt at least lowest level fair balance and PAAB review.

Hello @username

It is likely that this would be considered advertising and not subject to the exemption criteria outlined in Section 1.5D of the code which state “Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages”. The promotions of advertising tools would be considered a link to promotional messages. When we link advertising to non-advertising, everything becomes advertising.

@jennifer-carroll Thanks Jennifer, no further questions at this time.

Hey @akar

The Distinction Between Advertising and Other Activities, the Health Canada document which outlines what constitutes advertising, asks a series of questions to determine the nature of the activity. The author and distributor being a medical director in and of itself, does not, in and of itself, necessarily render a piece exempt from Federal advertising regulations, the PAAB Code, or PAAB preclearance. Please see PAAB Q&A 403. While this question asks about “slides”, the same would apply to letters, emails, etc.

PAAB Q&A 750 also walks through a similar set of questions to ask about the activity.

A letter stating only that the sponsor’s product is available would be exempt from preclearance regardless of the source within the company. But it should be noted that certain industry association Codes do not permit such promotional materials to be signed by Medical/Scientific personnel.

Similarly, a letter only indicating that the sponsor’s product is not available would also be exempt. However, in my experience, when such a letter is signed-off by medical/scientific personnel, it’s because the letter goes beyond that simple message (e.g., why the shortage exists, when the shortage is expected to be resolved, what is being done to mitigate the shortage, what prescribers can consider in the meantime, or so on). Anything on this matter beyond the fact that the product is available or unavailable would require preclearance.

If you are unsure if the activity would be considered advertising, and if that advertising requires review, please submit a request for a written opinion (see fee schedule on the PAAB website).

@Jennifer-Carroll said in Linking out to RAMQ website:

A link to the formulary site for any province would render the piece subject to review. While a message of “now on formulary” may be considered exempt and the formulary alone is not within the scope of the PAAB code, the linking of the two pieces renders the content subject to the advertising provisions as it creates a link between the brand and a therapeutic message. As per PAAB Q&A 565, the link to RAMQ coverage would be considered a therapeutic link. Hope that helps.

Thank you for clarifying Jennifer!

Good Morning @rcolbear

As per “Chapter 4. Post Approval” in the document “Guidance on Submission Process”, a request for extension can be submitted for assessment. An annotated copy of the product monograph with all changes since the previous TMA should be uploaded. The PAAB will make an assessment to see if the changes to the product monograph impact the piece. It is possible for changes deemed to be “minimal” by the sponsor, to still have a meaningful impact on the piece. Upon PAAB assessment, if the piece is still deemed to meet the requirements of the Code, a maximum 2 month extension can be granted.

Note that it is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods.

Thank you for the question.