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Advertising is required to be consistent with the Terms of Market Authorization (TMA) per Food and Drugs Act section 9.1 and PAAB code section 3.1. If the TMA changes such that the advertisment is no longer consistent with it, then the manufacturer must update the advertisment promptly. It is possible for the provided preclearance period to be rendered invalid by factors including TMA updates and market place changes. Please call the PAAB office if you want to discuss your specific situation.
The data appearing in a product monograph is based on a pivotal trial. The same study also discusses 'off-label' endpoints. Can reps distribute the reprint of the study to support data that is in the PM?
Before reading this answer, please read Q&A #175 and #45 as they provide important background reference to the Health Canada policy document "The Distinction Between Advertising and Other Activities" and the PAAB code. Distribution of materials through a sales representative is likely to be (or eventually become) a promotional activity. Off-label promotion would contravene section 9.1 of the Food and Drugs Act.
The scenario in the current question differs slightly from that identified in question 45; however, in that the study is a pivotal trial which presumably has data presented in the clinical trial section of the product monograph. Given this nuance, it is PAAB's interpretation that it is possible to distribute this reference through the sales rep. BUT, you'd want to ensure that the reps are trained not to discuss any off-label (i.e. non-PM) content. You also want to ensure that the reprint is the complete and unedited published and peer-reviewed pivotal trial. Also consult the Rx&D code.
For all sections you've listed, the content must emanate from part III of the product monograph. Where there are multiple distinct part III sections (e.g. for different conditions or formats) an entirely different document for distribution must be created. The tonality in the document must be non-promotional. Make sure you read PAAB code section 6.4.3 at the onset of your project.
Yes, if you discuss the proposed content from part III of the PM, you should also provide safety information. This safety information should be derived from part III of the PM, not be the healthcare professional advertising safety information. As the product has already been selected, you can focus on boxed & bolded content from part III of the PM in addition to content describing what can go wrong on the medication and what to do about it (e.g. when it is sufficient to set-up a doctor's appointment versus when you need to go to the ER etc.)
A product is not yet approved in Canada but approved in the US and Europe. In an international conference held in Canada, can we invite Canadian healthcare professionals to attend an company-sponsored talk within the conference auspices...and the presentation includes the unapproved product?
No. Targeting Canadian HCPs and inviting them specifically to this segment of the event appears to render the segment subject to Canadian advertising regulations. Advertising activities targeted to Canadian healthcare professionals (HCPs) are required to be consistent with the Health Canada approved Terms of Market Authorization per PAAB code s3.1. The proposed activity would appear to contravene section 9.1 of the Food and Drugs Act and section C.08.002 of the Food and Drug Regulations. Our position is also based on the Health Canada policy document "The Distinction Between Advertising and Other Activities" which provides a list of 7 questions which help differentiate between promotional and non - promotional activities and 4 additional provisions relating specifically to international conferences.
In addition to considering the aforementioned codes, regulations, and policies, its generally a good idea to reflect on the optics of potential marketing activities. Although it may not actually be your intent, it may appear that your intent is to promote to Canadian HCPs drugs and uses which are not approved in Canada (i.e. off-label).
A consideration may be for the Global headquarters (not the Canadian subsidiary) to promote the international conference itself (rather than this specific segment) to HCPs from multiple areas across the globe where this is permitted (i.e. including Canadian HCPs but not targeting them specifically). Make sure you refer to the relevant provisions in the Rx&D code and follow the advice of your legal department.
I assume (perhaps incorrectly) that you are referring help seeking announcements. I.e. A piece asking consumers who have a particular medical disorder to consult a physician for discussion of treatment, or call a 1-800 number or visit a website. If so, I direct you to the following link.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php
Such piece should not identify specific drugs. The drug manufacturer may not be identified either. Visit the link for the rest of the requirements relating to this sort of piece.
Claims of bioequivalence are pharmacokinetic in nature. A piece containing only such claims (with the indication) would require middle level fair balance.
I am unsure whether the question refers to HCP branded content or patient branded content. I am also unclear what type of symptom data is presented and in which context. For example, are we talking about which symptoms are addressed through certain non-pharm tips, are we talking about differential diagnosis, or are we talking about symptoms of the condition in general?
I'll therefore respond in broad terms highlighting what, in my experience, clients tend to be most surprised about when dealing with disease information. This is not meant to be a comprehensive list of all potential pitfalls. The provisions discussed relate to PAAB code s3.1.
All information in a branded APS is required to fall within the limitations of the TMA. Clients are sometimes surprised to learn that disease content is restricted by the featured product's authorized indication. Also, note that specific symptoms which are called out in APS should generally be identified in the TMA. For HCP
adverting, clients are sometimes surprised to learn that some disease information presentations trigger the need for quantification of the drug's effect on the highlighted disease issue. For example, the message "72% of patients with allergic rhinitis say that their symptoms are affecting their quality of life" would require inclusion of clinical trial data (meeting all relevant PAAB code requirements) which communicates the extent to which the promoted brand improves QOL vs the active or inactive comparator.
Does "coming soon" on an approved product require PAAB approval?
A piece containing only the message "Drug X is coming soon" with absolutely no other message (implied or stated) within the piece AND absolutely no link to therapeutic or promotional messages is exempt. Note that the manufacturer is responsible for ensuring that this message is employed only AFTER the product has been approved by Health Canada. It is prohibited to advertise a drug product prior to Health Canada approval.
Let us know at the initial submission stage whether the reference list will appear within the patient information piece. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece. Either way, note that we require the reference list (and annotated references) for our review of the APS content. Footnotes which are approved as part of the copydeck must appear in the piece. In fact, all APS content must always appear exactly as approved.
Our client would like to have a website about the features of its medical device (a self-injection device). The website would not mention the name of the drug that goes in the device but it would mention the therapeutic area. The intended audience is patients who would be directed to the website by their HCPs. Am I correct that this website requires PAAB pre-clearance?
What if the website had content only about the features of the medical device and did not mention the drug product in any way and did not mention the therapeutic area, would it then be exempt from review since the PAAB doesn't review medical devices? Or would it require pre-clearance because it is sponsored content that patients are being directed to? Thanks in advance for your response.
Federal law requires you to promote the approved name of the product within the federal category in which it was approved. If it is approved as a drug then it requires PAAB approval. If it is a medical device (i.e. a category I, II, III, or IV medical device) no approval is required.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
