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    3. Terms of Market Authorization
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    • S

      Scope of Terms of Market Authorization - strictly limited to Product License?
      • spi555

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      Jennifer Carroll

      Good Morning @spierf

      The general principle to keep in mind is that therapeutic claims must be consistent with the product’s Health Canada approved “Terms of Market Authorization” (TMA). In the Natural Health Product (NHP) realm, monographs such as the Multi-Vitamin/Mineral Supplements Monograph are intended to serve as a guide to industry for the preparation of Product Licence Applications. Once the NNHPD completes its review of the PLA form, the approved components of the form are reflected on the Product Licence. As such, for NHPs, all claims in advertising should be consistent with the Health Canada approved Product Licence corresponding to the particular product in question (as this is the TMA for said product).

    • G

      Information about controlled substance advertising regulations
      • gbrl88

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      Jennifer Carroll

      Hello @gbrl88 ,
      We’ll begin by reiterating that promotion of these products to the public is strictly prohibited. Now onto your question. With regards to HCP advertising, the provisions of the PAAB Code apply to all healthcare products including narcotics and controlled drugs.

      The Food and Drugs Act, the Food and Drug Regulations, the Controlled Drugs and Substances Act, and the Narcotic Control Regulations outline Federal requirements pertaining to promotional materials and promotional activities (including sampling). Note that provinces may also impose additional local restrictions pertaining to sampling activities. The Innovative Medicines Canada Code of Ethical Practices also contains standards pertaining to the activity of sampling.
      You may have heard that Health Canada has recently amended healthcare product sampling laws. These amendments came into effect on July 1, 2020. But they do NOT impact sampling pertaining to controlled drugs.

      Importantly, for opioids (specifically those on Part B of the Opioids list), Health Canada has established Terms and Conditions that must be adhered. This was followed by additional restrictions on marketing of opioids.

      Does anyone in this community use additional resources pertaining to the question? If so, sharing is caring! Post them in this thread.

    • Jennifer Carroll

      707 - Hi, For the balance copy requiring a direct link to the Product Monograph - the guidelines state that a link to the Health Canada database along with DIN number would work in lieu of a corporate URL. If going this route, is it sufficient to say: "Search the Health Canada Drug Product Database and search DIN XXX for...." OR must the database URL be written out? It is quite long: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) Much thanks!
      • Jennifer Carroll

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    • Jennifer Carroll

      538 - What are the implications, if any, for a Product having "monotherapy" in the dosing section vs in the indication section of the PM? Does it matter that it's under "dosing considerations" as opposed to "indication" if it's still on the Product Monograph? How would PAAB limit advertising for this? Would the sponsor only be able to mention monotherapy, if at all, if: (1) they use the verbatim statement from the PM, (2) they don't put that statement with the indication statement and (3) they don't make monotherapy the main theme of the APS?
      • Jennifer Carroll

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    • Jennifer Carroll

      530 - What is PAAB's position on proactively providing storage/stability information to customers that is different than what is in the Product Monograph, but which is supported by clinical data? We sell a product that requires refrigeration between 2-8 degrees. Our Med Info department receives many, many calls inquiring about temperature excursions outside of the labelled storage conditions. We have data to support the excursions. We would like to be able to proactively provide temperature excursion data to customers to make it easier for them to know what to do if they experience an excursion...and so that they would not always need to call us. Is this permitted?
      • Jennifer Carroll

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    • Jennifer Carroll

      527 - What is the equivalent of product monographs for NHPs? Is it the Product Label , the Product Insert, or the Evidence Summary Report that we are submitting to Health Canada? For instance, if we want to include some precise figures in the promotional material for HCPs, do we need to include them in the Evidence Summary Report? Also, to obtain the right to have a graph or a table in the promotional material to HCPs, is the mention of the figures enough in the document that acts as an equivalent to the Product Monograph, or do we need to include also the graphs/tables?
      • Jennifer Carroll

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    • Jennifer Carroll

      406 - In an unbranded context, is it possible to use a guideline treatment algorithm that recommends drugs that are off label for the condition it pertains?
      • Jennifer Carroll

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    • Jennifer Carroll

      398 - In the current consultation by Health Canada on the Guidance Document: Product Monograph Release Part I: Health Professional Information and Part II: Scientific Information, Health Canada proposes to remove references, as per the response to question 309 , what impact would removal of references have on the utilization of the study by companies if not listed in the PM?
      • Jennifer Carroll

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    • Jennifer Carroll

      396 - Does PAAB let us place information in detail aids that is in a reference found in a PM but not in the PM text itself?
      • Jennifer Carroll

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    • Jennifer Carroll

      337 - When we have an update on our product monograph, do we need to revise the piece related to the product and resubmit to PAAB right away or we can wait for the PAAB renewal date?
      • Jennifer Carroll

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    • Jennifer Carroll

      327 - Hi There, Our client has just received NOC to a new product. They do not have a large Sales Force and therefore is not looking to develop comprehensive materials. They would like to take their approved Product Monograph and highlight key messages within it - not changing any copy/content - but just simple draw attention to specific sections, such as patient groups, efficacy and adverse events. We would submit the highlighted PM through PAAB for approval - but before we go into development I just wanted to confirm this would be something PAAB would allow.
      • Jennifer Carroll

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    • Jennifer Carroll

      326 - Can we create a comparative timeline of 2 products (1 ours and 1 a competitor) from the same therapeutic category and who have some of the same indications? The timelines would only show indications, which ones each product has and when they were received. Thank you.
      • Jennifer Carroll

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    • Jennifer Carroll

      322 - Dear PAAB, If data or statements exist in the product monograph but has no statistics associated with it, is it approvable?
      • Jennifer Carroll

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    • Jennifer Carroll

      309 - Is the definition of "TMA" equivalent to or broader than the Product monograph? Are in-vitro studies on the MOA of a drug or drug components submitted to and reviewed by Health Canada as part of the NDS acceptable for use as supporting reference to non-clinical claims in promotion materials (as data on file) even if the published reference is not in the actual bibliography of references in the PM?
      • Jennifer Carroll

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    • Jennifer Carroll

      275 - We have prepared a Patient Tear Off Sheet for Product X which provides information on the indication, dosing/administration, side effects, talk to your doctor immediately if you have x,y and z and interactions with drugs. My question is with respect to "Product X may interact with drugs to treat: Chest pain, angina (e.g. amyl nitrate "poppers") HIV infections (e.g. indinavir or itraconazole) Fungal infections...
      • Jennifer Carroll

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    • Jennifer Carroll

      203 - Hello, i am looking for an official definition of on-label as it relates to conversations that a pharma rep can have with a HCP. Although all material need to be PAAB-approved, verbal exchange in the office can touch on latest data publicly available, such as posters, conference reports, etc. If referring to approved dosage, patient population and condition, can the reps discuss this with physicians in an effort to have robust clinical and scientific discussions... best regards
      • Jennifer Carroll

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    • Jennifer Carroll

      202 - We would like to reference other clinical studies from independent researchers relating to our product. Purpose is to highlight other research results & findings on different groups of patients. Research has been submitted with the PLA to support other claims used on the packaging but this research claims additional benefits. Am I able to use this research to state the results from these studies without it being in conflict of the claims made on the packaging/PLA? Please advise.
      • Jennifer Carroll

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    • Jennifer Carroll

      156 - Could a competitor product monograph or clinical study be used by sales reps during a call to answer a request? The info would be 'on label' and it would be for an unsolicited request (used reactively).
      • Jennifer Carroll

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    • Jennifer Carroll

      150 - In 3.1 you state claims must be consistent with,and within the limitations of, the Health Canada Terms of Market Authorization. I assume "consistent with" means similar to or paraphrasing what is in the PM. What "limitations" of the TMA are you referring to?
      • Jennifer Carroll

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    • Jennifer Carroll

      146 - [empty]
      • Jennifer Carroll

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