No. The specific indication for each product must be the same. If the products are indicated in different subtypes, they are not considered to have the same indication and therefore should not be compared. See code section 5.1 and 5.2
Afin de soutenir la demande croissante, nous avons modifé la section Demandez au CCPP et l'avons rendu plus facile d'utilisation. Vous pouvez désormais sélectioner la catégorie qui vous interesse dans le menu déroulant et voir les questions qui ont déjà été posées et répondues. Vous pouvez également faire une recherche parmis les questions déjà soumises au CCPP depuis les débuts.
We would like to make non-clinical comparisons between products that are specifically indicated for different subtypes of a disease state (eg. phenotypes of COPD). Would this be acceptable, given the common umbrella disease state?
No. The specific indication for each product must be the same. If the products are indicated in different subtypes, they are not considered to have the same indication and therefore should not be compared. See code section 5.1 and 5.2
We have an ongoing pivotal study and would like to report the latest published data. While the data exceeds the duration of that mentioned in the TMA, it is directionally-consistent with respect to magnitude/significance, and no additional safety concerns were identified. Can we report this data in APS, if there is no emphasis placed on the duration?
No. PAAB review is based on the Health Canada approved terms of market authorization. Published studies must be consistent with and within the limitations of the TMA to be considered for inclusion in advertising. Consistency with the TMA is assessed based on a number of parameters, including the duration of the study. If an ongoing study goes beyond the duration of use within the TMA, this would be deemed to be outside of the limitations of the TMA. Copy indicating that Health Canada has reviewed and accepted the efficacy and safety of the product for the extended duration would be required prior to assessing the acceptability of the data in advertising. Please see response to Question #585 as well: No. The data from the later analysis can only be included in the piece once it is included in the TMA
For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient?
The document “Tips and checklist for creating and selecting fair balance” on the PAAB website provides a list of questions that can help you determine what level of fair balance is required based on the messaging within the piece. A presentation where the highest level of messaging is restricted to dosing and administration information such as “dosage form” and “dosing instructions” would fall under the category of “Non-pharmacologic claims” Lowest level fair balance is sufficient to balance non-pharmacologic type claims.
For an HCP targeted APS, are references required in the final layout of the piece after PAAB approval (i.e., a reference list at the end of the piece and superscripts throughout)? Or do references not need to be included in the layout once PAAB has approved the copy doc? Thanks!
For HCP targeted advertising, references are required in the final layout of the piece. Yes, as you said, this entails a reference list at the end of the piece and the corresponding superscripts throughout the piece. An alternative is to use the superscripts throughout the piece but include the corresponding reference list in a web location corresponding to a URL presented on the piece. See the PAAB code sections 4.4.3 to 4.4.7.
This is required for adherence to PAAB code section 3.3 (i.e. an HCP would need to know which reference to request from the manufacturer if he/she wanted additional info or wanted to test the evidentiary basis for a claim).
Hi; I have a questions regarding usage of the trade mark of the competitor in the promo materials. The owning promo material company wants to include the registered information from the competitor's PM. would it be acceptable to use the competitor's registered trademark in the piece? Thank you
It may or may not be acceptable to use content from a competitor’s PM so your question may be found to become moot (if in doubt, you may want to submit a written opinion before you go too far – see the fee schedule on our website). Nonetheless, in response to a more general question about competitor trademarks such as the trade name, yes we’ve approved their use in advertising. Make sure you acknowledge competitor’s trademarks per PAAB code section 5.17. This is not a legal opinion. If you have more specific questions regarding trademark use or if you are considering something out of the norm, I suggest you consult with your legal department.
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).
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de