Hello. Please refer to Q&A 374.
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Hi PAAB. I would like to inquire about the requirements for PAAB material review relating to a company-sponsored symposia (non CME/CHE accredited) being held at an International congress occurring in Canada. The symposia is being developed by the sponsors Global team, with both speakers internal to the organization and some external. If there is no mention of any specific licensed product during the presentations, is PAAB material review required? In another scenario, if case-studies related to a licensed product(s) (vaccine) in Canada were included in the presentation material to provide practical examples and inform the clinical discussion, would the materials require PAAB review? Thanks very much
Hello. Please refer to Q&A 374.
Has the PAAB ever considered providing review comments as annotations on submission documents, rather than an itemized review letter? This would seem to save both PAAB and Clients time.
This was considered when we first created the eFile system for the very reason you suggested. On the surface, it appears to be a good idea, but it was deemed at the time not to be practical. Itemized correspondence letters appear to be a more efficient way (for clients and PAAB) to engage in the back-and-forth that frequently occurs during the review process. The copydeck would get quite crowded with the reasoning and counter-reasoning defending each party’s position. This would be true whether the comments appeared directly on the copydeck or as digital sticky notes. The lion’s share of the time use appears to be due to the back and forths. It might therefore be counter-productive to take a step which could impair either party’s ability to follow the flow of reasoning and counter-reasoning. Keep in mind that the reasoning or counter-reasoning in a single correspondence for a single comment can sometimes be multiple pages long. This was the thinking at the time. Years have passed and technology has evolved so feel free to reach out to me if you have ideas on how the system can be improved.
I have two questions as it relates to pre-NOC submissions. (1) What constitutes a 'final draft' PM? Typically a PM is not deemed 'final draft' by Health Canada until approximately 1 week prior to actual NOC. We would like to make pre-NOC submissions earlier than this. (2) Can we submit a full HCP Detail Aid as a pre-NOC opinion request, or are opinions limited to simple reviews, such as core creative?
“Final draft stage” means that the sponsor is not expecting any changes to the draft copy submitted. Prior to this point, you are limited to submitting an opinion. An opinion is not a full review, it entails the provision of a single set of comments from PAAB. Prior to final draft of the PM, an opinion will only be provided on the core creative using only the draft monograph as a reference. Other types of opinions are not provided prior to final draft (e.g. we would not provide an opinion on a study). Other types of opinions can be submitted after final draft but these would count toward the maximum of two APS for pre-NOC submission.
Once the PM is at final draft stage, then submitting the detail aid for a pre-NOC review would result in a detailed line-by-line review. Once all PAAB comments are addressed, approval for pre-NOC reviews is not granted until the product receives NOC from Health Canada. For more information, please refer to the guidance document “Administrative Guideline for the Review of Pre-NOC Advertising Submissions “ on the PAAB website.
We’re working on a new product launch and our client is looking to do a PAAB-exempt pull up banner (just product logo and legal text), however, this product has received an NOC/c approval. Are we required to put the NOC/c box on the banner, which disclaimer sea the indication statement?
Inclusion of the NOC/c box would disqualify the ad from being exempt. Exempt messaging restricted to product name and legal text, would not prompt the requirements for placement of the indication and NOC/c. As a caution, note that if the product logo suggests therapeutic use, this would prompt the requirements for the NOC/c box on the banner and would no longer be exempt from review. PAAB can provide an opinion (see the fee schedule on our website).
Hi there, We have some emails with only company information, no talks about therapeutic area, nothing about brand. We plan to send it through PTM targeting HCPs. Does this need PAAB approval? Thanks
There are cases where corporate messages are subject to the PAAB code. See PAAB code section 7.4 for messaging considered to be within the scope of a reviewable corporate message. If you are still uncertain, you could use the opinion service to ensure the piece is exempt (see the fee schedule on our website).
Is there any particular PAAB guidance around acceptability of a program names for patient support programs? Is the name something that requires PAAB review? Any further details you can provide would be appreciated.
Advertising pieces for patient support programs, including the name of the program, are subject to the PAAB code. Please see the PAAB Tips and Cases document “How to present support program names” under the resources tab on the PAAB website.
We're developing a branded slide deck for HCPs that will include mention of adverse events as stated in the Product Monograph. It is our intent to provide HCPs with information on how to manage adverse events (e.g. educate patients on dietary measures, consider consulting a dietitian to modify patient diet if required, etc.). Is it correct to assume that the information on how to manage adverse events within this branded APS must be supported by a textbook or recognized third-party website/materials?
Yes, for such statements related to the non-pharmacological management of adverse events, we could consider sources such as medical textbooks and websites of authoritative bodies. Keep in mind that we would still assess consistency with the product monograph and additional information may be required.
Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!
If this was a “requirement” stated in the Qualifying Notice, then the request from Health Canada would be mandatory. Otherwise, note that preclearance is generally voluntary. Although preclearance is not required by law, compliance with Food and Drugs Act section 9.1 is mandatory. The essence of this act is that advertising must not be misleading. Little direction is provided in the Act on how not to mislead. This is what the PAAB code is for in HCP advertising. As PAAB adjudicates the PAAB code, PAAB preclearance is the most objective and effective mechanism to attain compliance with the code and, as a result, the Food and Drugs Act. In my mind, this is the most compelling argument in favour of preclearance. In the interest of promoting self-regulation, we report cases of willful non-compliance to Health Canada upon learning about them through our monitoring activities and the complaint system (i.e. the competitor’s monitoring activities). As a secondary point, some trade organizations require preclearance as a condition of membership.
Further guidance for NOC/c advertising requirements can be found on the PAAB website in the document “Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOCc)“.
Is it acceptable to advertise a statement that says something along the lines of: "Drug X is the only drug containing active ingredient Y that is approved from clinical tests?" assuming that this statement is true? Would that change if the statement is more specific, such as "Drug X is the only epidural drug containing active ingredient Y that is approved from clinical tests?"
I cannot answer this question as I am not sure what you mean by “approved from clinical tests”. This is not the forum for assessment of particular claims anyways so I suggest submitting your particular question as an opinion (see the fee schedule on our website).
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