Hello @reed-wigs Theoretically it is possible, however there are several considerations. For example, if the PSP is therapeutic area specific, it would create a link to the other brand for which patients only on one product are not on and would not be acceptable. If the PSP is not therapeutic area specific, it would require verification that the patient was on both products and within the PSP, the content would need to have been reviewed and approved in the context of both products. If it was therapeutic area specific, the content would still require review in the context of both brands. If the products are in different therapeutic areas and the content is different based on the product, there would need to be clear delineation between therapeutic content. These are just some considerations. We would suggest that you submit for an opinion so that we may assess and provide direction in the context of the specific program and application.

@gmc In PAAB’s view, Canadian medical/regulatory review of international conference materials is an appropriate mechanism for determining whether the sort of disclosure statement outlined in the fourth bullet of the Distinction document’s section on international conferences is required to be affixed to the ad. However, tailoring the ad for Canadian HCPs (beyond simply affixing the aforementioned sticker) would likely render it subject to all applicable Canadian Federal advertising regulations, regardless of whether the revisions are implemented by the parent company or the Canadian subsidiary. Given that the ad was generated from a non-Canadian label, its deviations from the Canadian regulations likely go beyond the product’s local naming/branding conventions and risk disclosures. The course proposed in the question would therefore appear to render ad subject to Canadian advertising regulations while falling short of achieving full adherence with those regulations. The resulting ad would likely also deviate from the regulations that are applicable in the jurisdiction from which it originates. In our opinion, based on the limited information provided, it would be best to EITHER: • Make no modifications to the ad itself, and instead affix a sticker conveying that the product is not authorized for sale in Canada or that the product is authorized under a different name for different indications in Canada (if applicable). Canadian HCPs should be invited to refer to the Canadian monograph. • Revise the ad so as to fully bring it into adherence with all applicable Canadian regulations (and confirm this through the PAAB preclearance mechanism).

Thank you for the information!

Hello @au3010 Controlled distribution of an access code (e.g., the QR code) through the package labelling would allow the sponsor to take the patient behind the gate to a PAAB approved patient site. As a reminder, package labeling should be reviewed by Health Canada.

Hi @chagali-toney-0 Co-promotion of a brand and a separate disease state would be difficult to do in a single email as the nature of the communication inherently links the two features regardless of the look or disclosures. We would recommend two separate communications. Remember that when you link branded and unbranded, everything becomes branded. Q&A 356 provides greater detail around proximity.

Hello @colin This sounds like it might be possible in an APS that is both product and disease agnostic but it is difficult to say with confidence without knowing the emerging technology, it’s approved applications, the discussions within the piece and their implications to current or future therapeutic areas etc. If the specific example cannot be provided in a public forum, an opinion may be a better option.

Hello @donna We suggest checking with the respective trade associations for acceptability of sample activities. For advertising, unsolicited communications sent to HCPs to promote availability of samples that go beyond a simple “request form” could be considered advertising and subject to the PAAB code. Please see PAAB Q&A 47, 58, 494 ,and Sampling Announcements

@jennifer-carroll Thank you for the clarification.

@gmc Yes, unbranded patient and HCP websites can link to corporate PP and TOU pages post gate.

@jennifer-carroll Thank you so much Jennifer

Hi @keoca Yes. Messaging should be clear that you are directing them to the website to see content intended for patients.

Hello @joao-borges In general, the letter should be signed by someone from medical or regulatory within the sponsor’s company. There may be situations where a different signature is required. This would be addressed during the review process.

Hi @lags Thank you for your question. There are many factors that will affect the direction and use of both product logos in APS. This forum is not intended to address the specific and complex scenario that has been described. We suggest a consult meeting be arranged with PAAB to fully disclose the nature of the promotion and the content in the respective product monographs. We are unable to provide guidance without further information. Consult meetings may be arranged through our administrative team at review@paab.ca

Hey @tmcm The inclusion of the indication would prompt, at minimum, lowest level fair balance and would not be considered exempt. If exemption is the goal, we suggest submitting for an exemption opinion (see Exemption Request Policy and Procedure). This will allow the reviewer to assess the content and determine if the piece is exempt, or advise on changes to make the piece exempt. The exemption criteria require that there is no therapeutic mention or promotional marketing message about the product. It’s possible to still have promotional marketing messages even if they are not therapeutic messages (i.e. labeled blisters to help track dosage).

Hello @kshulist When the piece speaks to what the drug is for (beyond what is consistent with the Part I indication), how it works, and/or its various features, the piece should contain safety information. The principle is that patient pieces should be balanced and complete. They should not be about overly selective presentations from part III of the PM.

Hey @justineeve Please see code section 1.5E.

@jennifer-carroll Thank you very much!

Happy Monday @tmcm Anything that implies that something is “new” would be bound to the one year time frame. As "news" can be defined as “a report of recent events”, this copy does tend to imply that the announcement is in regards to something new.

Hi @dj, In general, there is no distinction between what manufacturer employees post on a company account and what they post on their own personal account for company unbranded campaigns. A post that contravenes the Federal regulations on a company account likely contravenes those same regulations on an employee’s personal account. Additionally, even when a post is aligned with applicable Federal regulations on a company account, it may be a contravention on a personal account as the context may differ substantially. Ultimately, the company has not curated the content on the employee’s a personal account to ensure the overall context and linkages are appropriate. Posting (branded or unbranded) campaign content blurs the line between corporate and personal accounts. We encourage manufacturers to set internal social media guidelines that convey expectations vis-à-vis social media activity of their employees (and their agents).

@Kiki Thanks @palanski for the thorough answer. Your response is accurate and complete.