Hello @shotk7

PAAB exemption criteria can be found in section 1.5 of the Code. At the root of this question is if this piece is advertising or not. The Health Canada policy document "The Distinction Between Advertising and Other Activities" is a valuable tool in determining whether materials are subject to the advertising regulations. The document poses questions and factors to consider (e.g. content/context, content creation, distribution, etc.) when determining if a message falls within the definition of advertising, including “Who sponsors the message and how?”. Whether the HCP piece would require PAAB preclearance also depends on the type of entity which is creating the piece and the relationship between the sponsor and that entity. In general, no single factor will determine if a particular message is promotional (e.g. third-party does not confirm that it is not advertising). Lack of mention of a specific product also does not render something “non-advertising”. Various possible scenarios and the corresponding answers are covered in the following document: Guidance on which HCP materials require PAAB review. Submit an opinion request if you have remaining questions about a particular tool or process (see the fee schedule on our website www.paab.ca)

Hey @tk2022

Q&A #763 refers to just one scenario which could render a piece exempt. The tool outlines other factors/scenarios that may or may not render a piece exempt from PAAB pre-clearance.

Can you please provide us with the flow you followed through the tool and the nature of the piece you’re thinking of (unbranded/branded, treatment/no treatment, company generated/independently generated, distribution, etc.)? This will help us better assess the question. (Note 6.6. in the document will be updated to 1.5D per the current code.)

Hey @gmc

Food and Drug Regulations – C.01.007

@jennifer-carroll Thank you !!

Hello @arat101

Q&A 577 and Q&A 516 should answer both your questions respectively.

Happy Friday @vincent

The nature of this question is complex and there is more information that would be required to answer it. We would suggest submitting an opinion where all the details required to make the assessment can be provided.

Hi @jennifer-carroll,

That answers any lingering questions I had, thank you so much for taking the time to explain!

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.

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.