Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists

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K

Linking mid-level FB to an attachment with high-level (in an email)
• kshulist

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K

@jennifer-carroll Thank you!
243 - If a product has multiple indications, but we are developing a promotional piece for just one of those indications, does the fair balance copy still have to contain all indications and balance copy for ALL the indications? Thank you.
• Jennifer Carroll

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Hey @matt-s17

If the warning and precaution is clearly limited to one indication which is not presented in the piece, then no, it would not be required in a piece which did not have mention of that indication.
97 - Is there a current practice to use a symbol "PR" to designate a prescription drug, like in trade-marks where the symbols "TM" or (R) are used ? And if so, what are the rules of use for such symbol?
• Jennifer Carroll

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Hey @gmc

Yes, inclusion in the logo qualifies. The answer above is based on an older version of the code. The current code section 2.2 states: In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible.

It can appear anywhere in the piece as long as it appears at least once.
J

Co-promotion agreement advertising responsibilities
• jesse.gibbings

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Hello @jesse-gibbings

If you have entered into a contractual agreement with the MAH to co-promote the products, you should ensure that all advertising meets the regulatory standards for both your products and the MAH products. See Code section 1.4.c.
U

NOC/c disclosure in HCP materials
• Username

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Good morning @Username, sorry for missing this question – let's see if we can still help you with this

It's important to not confuse the directions for patient pieces and HCP detail aids. The situation you are describing in paragraph two appears to be mixing the directions for patient and HCP. Patient material should be non-promotional information. In the situation where there is a combination of multiple NOC and/or NOC/c’s which cross the same therapeutic category, the copy should be clearly limited to the NOC population. If the copy is broad and could encompass the NOC/c to some degree, the NOC/c would be required to be presented in the piece.

For the question in paragraph three, “at first mention of the therapeutic category” refers to pieces where there may be NOC and NOC/c in different therapeutic categories. For example NOC for RA and NOC/c for UC. If the piece doesn’t mention UC until page 3, the NOC/c disclosure is not required until that page as that is first mention.

In a situation where you have one NOC and one NOC/c within the same therapeutic area and presented together upfront, the first presented option within the document Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc should be followed. For example, the complete boxed NOC/c copy from the cover should be presented.
758 - In the PAAB Fair Balance guidance, for lowest level FB, it states "messages which do not relate to the healthcare product (e.g. disease information)". Question is: If the message does not relate to the product and only disease info, why would we require any FB at all? it is not advertising. Or could you provide an example for this scenario?
• Jennifer Carroll

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736 - We're developing a pull-up banner and the amount of Fair Balance is not allowing for space for the message. Could we apply the principles allowed for journal ads? Specifically, have medium fair balance on the pull-up banner and direct the reader to a handout adjacent to the panel with the full fair balance?
• Jennifer Carroll

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679 - In the fair balance when we direct customers to a site for the Product Monograph, should we direct them to the Health Canada Drug Database page or to our corporate page with the monograph? We have concerns with directing them to the Health Canada page as they do not always post the most up to date version of the Product Monograph or sometimes the French version is not available.
• Jennifer Carroll

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669 - If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products?
• Jennifer Carroll

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664 - In the "other relevant warnings and precautions" section of the highest-level fair balance, is there a requirement to include warning/precautions about effects that were not systematically studied/evaluated and that are not class warnings. Here is an examples of what I suspect needs to be included: bullet point " seizures" if PM has "seizures" bolded followed by "xxx has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Seizures are a potential risk with antidepressant drugs. xxx should be prescribed with caution in patients with a seizure disorder." Here is an example of what I suspect does not need to included: bullet point "cognitive and motor disturbances" if PM has "cognitive and motor disturbances" bolded followed by "The effects of xxx on the ability to drive or to operate machinery were not systematically evaluated...
• Jennifer Carroll

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662 - Hi Patrick, I have the following question: When using the terms "proven efficacy" in a headline in the context of what the product is indicated for, why do we need high level fair balance? For example, "Product X has proven efficacy in the treatment of Arthritis." If the product has received an indication for the treatment of arthritis, it has been shown to be effective - otherwise it would not have received such an indication. So, this headline is simply a factual statement, as opposed to a clinical claim. Thanks in advance for your clarification.
• Jennifer Carroll

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661 - In an HTML email, does the layout need to include the full product monograph address i.e. www.Bestpharma.greatdrug.ca/productmonograph.English , or can it just read click here for Product Monograph. The word 'here' would be bolded and link directly to the unmodified PM. Please let me know.
• Jennifer Carroll

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655 - We would like to do a table comparing non-clinical aspects (indication, route of admin, dosing, monitoring, etc.) of various products indicated for a specific disease. There are more than 10 drugs with this indication, so it will contain a lot of information, all of which will be based on the respective product monographs. It is our intention to give each brand equal prominence (i.e., it will not be specifically branded to one drug). What are the balance requirements for a piece like this? Normally, we understand that dosing warrants high-level balance. However, we can't possibly fit high-level balance for all of the product that will be mentioned in this piece. What do you suggest? Thank you!
• Jennifer Carroll

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625 - For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient?
• Jennifer Carroll

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586 - If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read "brought to you by a leading pharmaceutical company" or does it have to specifically mention the name of the company that provided the necessary funding.
• Jennifer Carroll

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580 - Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?
• Jennifer Carroll

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533 - For a piece which speaks to the safe handling of a drug product for HCPs, is fair balance required.
• Jennifer Carroll

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519 - We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required?
• Jennifer Carroll

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505 - Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label.
• Jennifer Carroll

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495 - If the safety information for 2 products is almost identical (the molecule being the same in both products), can we merge the two fair balances and indicate which safety information is for both products and which safety information is for only one of the products?
• Jennifer Carroll

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Linking mid-level FB to an attachment with high-level (in an email) • kshulist

243 - If a product has multiple indications, but we are developing a promotional piece for just one of those indications, does the fair balance copy still have to contain all indications and balance copy for ALL the indications? Thank you. • Jennifer Carroll

97 - Is there a current practice to use a symbol "PR" to designate a prescription drug, like in trade-marks where the symbols "TM" or (R) are used ? And if so, what are the rules of use for such symbol? • Jennifer Carroll

Co-promotion agreement advertising responsibilities • jesse.gibbings

NOC/c disclosure in HCP materials • Username

669 - If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products? • Jennifer Carroll

625 - For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient? • Jennifer Carroll

533 - For a piece which speaks to the safe handling of a drug product for HCPs, is fair balance required. • Jennifer Carroll

519 - We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required? • Jennifer Carroll

505 - Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label. • Jennifer Carroll

495 - If the safety information for 2 products is almost identical (the molecule being the same in both products), can we merge the two fair balances and indicate which safety information is for both products and which safety information is for only one of the products? • Jennifer Carroll

Linking mid-level FB to an attachment with high-level (in an email)
• kshulist

243 - If a product has multiple indications, but we are developing a promotional piece for just one of those indications, does the fair balance copy still have to contain all indications and balance copy for ALL the indications? Thank you.
• Jennifer Carroll

97 - Is there a current practice to use a symbol "PR" to designate a prescription drug, like in trade-marks where the symbols "TM" or (R) are used ? And if so, what are the rules of use for such symbol?
• Jennifer Carroll

Co-promotion agreement advertising responsibilities
• jesse.gibbings

NOC/c disclosure in HCP materials
• Username

669 - If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products?
• Jennifer Carroll

625 - For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient?
• Jennifer Carroll

533 - For a piece which speaks to the safe handling of a drug product for HCPs, is fair balance required.
• Jennifer Carroll

519 - We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required?
• Jennifer Carroll

505 - Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label.
• Jennifer Carroll

495 - If the safety information for 2 products is almost identical (the molecule being the same in both products), can we merge the two fair balances and indicate which safety information is for both products and which safety information is for only one of the products?
• Jennifer Carroll