If our company is displaying at a conference are we allowed to have unbranded tools that have information on the disease state while at the same time having branded information available (Ie dose cards etc) for delegates? When you link branded and unbranded, everything becomes branded. Having both a branded tool and an unbranded tool […]
Hi there. I submitted a question a few weeks ago regarding whether PAAB needed to review market authorization announcements that do not include any statement of the indication, however my question was not answered, so I am asking it again: Under the PAAB code, it is clear that under section 1.5(D) that a formulary announcement […]
We are currently waiting for approval for a new indication. Is there any way to disseminate unbranded disease information concerning this new indication before approval (ex: head office emails, medical emails, banner ads, etc.)? Please see PAAB document Pre-NOC Corporate/Editorial Communications for guidance.
Hello PAAB! I’m working on an unbranded piece that’s for HCPs. It discusses the impact that medication adherence can have on efficacy for a specific class of drugs. Being relatively recent, my brand’s drug is not discussed in most of the trials that evaluated the link between adherence and efficacy for this class of drug. […]
Hi, Is it possible to do pre-NOL PAAB submissions for a product already on the market? We know there is a new product monograph coming by the end of the year, but only minor changes to the product monograph are expected. The regulatory department from the company would do an attestation letter confirming this. Thank […]
We have a PAAB-approved print piece that we would like to use in a digital environment. None of the content of the print piece will change, but the layout will be different. Would it suffice to submit the new layout with the approved print-piece e-file number or will you need to re-review the content (i.e., […]
For a piece which speaks to the safe handling of a drug product for HCPs, is fair balance required. Yes. Lowest level FB.
Hi, I have a question about 3.1 specifically the section regarding claims consistent with the limitations of the Health Canada Terms of Marketing Authorization. There are some on our team that believe this means we are not able to use data that is not within the PM regardless. There are others that believe if a […]
On a company website, would we be able to show a picture of a drug along with name, price, quantity and product monograph? Would we be able to also link this drug page to a medical device that it is intended to be used with? Quite a bit of information is missing here. I'm going […]
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 […]
Re: Q#522 for use of Summary Basis Decision in advertising and you replied: “Yes. Provided the content referenced from it is not inconsistent with the product monograph”, if data from the SBD does not appear in the PM, can we use it? It would not be 'inconsistent'. If PAAB considers the SBD the same weight […]
Can the “Summary Basis of Decision” from Health Canada be used for advertising claims? Yes. Provided the content referenced from it is not inconsistent with the product monograph.
Hi PAAB. Do communications sent in the context of a patient assistance program need PAAB preclearance? here is the situation. we have a patient assistance program for which we would like the vendor to use a standardized and automated system to communicate information pertinent to patient's enrollment status, notifications regarding reimbursement investigations, reminders of missing […]
Can you please clearly define what is meant by a non-clinical claim? Non-clinical claims can include anything from IMS data (#1 prescribed claims), dosing, administration and quality of life. How do these fit under one umbrella? Sorry. I don’t quite follow your question. The listed claim types do not fall under one claim-type umbrella. Are […]
On an unbranded, consumer-facing, disease state website, it is permissible to discuss differential diagnosis? As in, could you “compare” the symptoms of the website condition with another, similar condition with overlapping symptoms? I’ll presume you are referring to a help-seeking message or consumer brochure meeting all applicable requirements of the Health Canada policy document “The […]
Good morning, Can we disclose the name of the company behind an unbranded website, when such is being asked in a specific tweet? Thanks in advance If any part of the campaign is help-seeking, the company may not be identified to the general public. If you receive a completely unsolicited request for disclosure of the […]
What is the status of advertising of Schedule II drugs (non-Pr but behind the counter) to the general public? Beyond name, price, quantity? It is the Federal Schedules (not the provincial schedules) that determine the advertising regulations. The restriction you referred to (i.e. name price quantity) applies specifically to products on the Federal schedule “Prescription”. […]
Can you please clarify why product MOA can only come from the TMA, and not published, peer-reviewed in vitro studies? MOA is frequently characterized post-NOC, particularly for products where ‘the exact mechanism of action is unknown’. The qualitative description of a product’s action in advertising must be consistent with its current Terms of Market Authorization […]
We currently have an APS submitted for PAAB review. We have experienced a delay in the project and we may not be able to respond to the last PAAB letter that we received for another 4-6 months. Is there an expiration on how long an unapproved e-file will stay open within our “Submissions” portal for […]
Section 3(1) of the Food/Drugs Act implies DTC-A is prohibited for products treating Schedule A diseases. Yet, there seems to be many approved DTC-A campaigns for STDs, Arthritis, etc. How is Section 3(1) being implemented in PAAB practice? PAAB DTCA reviews are a based on the Food & Drugs Act, the Food & Drug Regulations […]