Terms of Market Authorization
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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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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