With regard to fair balance requirement (section 2.4), would a Schedule 2 drug (behind the counter) be considered a ‘self-care’ product? For the purposes of the code, self-care products includes over the counter, natural health, and homeopathic products. Note that it does not include ethical drugs or schedule D drugs.
When constructing Fair Balance, under “Other relevant warnings & precautions,” are we required to include caution in use within certain patient populations where no/limited safety or efficacy data are available? In this situation, patients with certain medical conditions were excluded from the clinical trials, as is standard with other brands in the category. When it […]
A company is considering a patient support program. Before proceeding, they wish to conduct a pilot program that has been designed by an expert steering committee of specialists in the therapeutic area. Informed consent would be required from patients and the treating physician would give the information to the patient. During the course of treatment, […]
Is PAAB planning to have another general meeting in Montreal on e-filing procedure? I was not able to attend the Feb course. Please advise asap. Thank you. Unless we have at least 30 attendees it is not cost effective to conduct an open course outside the PAAB office. We are going to develop a webinar […]
Has the PAAB ever considered a “priority review” stream, whereby Clients could receive a shorter initial review (3-5 days vs 10) for a higher fee ($1000, $2000, etc)? There are occasions where guaranteed expedited timing is vital, and this option would serve the industry while generating additional revenue for the PAAB. To restrict use, Submission […]
I understand there is a PAAB webinar about recent changes on Thursday, 21 Feb 2013 at 10:00 AM. How can I participate? The link to the registration page is at the extreme bottom of the following webpage: http://www.paab.ca/events/#newpaab
The Code (in part) states: that patient information is exempt from PAAB review if the information is direct from and consistent with the product monograph. patient materials must be non-promotional. The questions, if by PAAB's interpretation, would the content of PART III of a product monograph be exempt if produced in a multipage brochure layout, […]
Are there restrictions on the use of the Australian flag in advertising? Assuming you are referring to Canadian drug advertising directed to HCPs, as in many situations, context would be important in determining the acceptability of the proposed image. Feel free to call the PAAB office to discuss your scenario. We are here to help.
I’m curious as to why the STI Innovicares program is allowed to advertise specific brand name drugs on a website without PAAB review; especially given two main pharmaceutical companies are behind a large promotion of their brands (AZ/Sanofi)? Isn’t this considered DTC advertising linked to brand name drugs? The website is at www.innovicares.ca and also […]
Is there a ratio needed between the graphic display (image) and the monograph font size? Please see answer #92.
Would a natural OTC Supplement (no DIN number) require PAAB approval for promotional materials targeted to HCPs? Would consumer advertising require PAAB and/or ASC? Per PAAB code section 11.3(a), APS promoting supplements purely for the maintenance of normal health do not require PAAB review. Note that APS directed to healthcare professionals (or patients through healthcare […]
I am seeking clarification on the recent PAAB advisory Jan 10 2013. If the “Now on Formulary” has codes which we include in the announcement is this still exempt? Secondly if we include codes and incluson criteria is this exempt. Thirdly if not exempt, do we then have to have full PI accompany the Ad. […]
Are there any guidelines (outside of color preference) for placement of the PAAB logo on an approved piece? Is there a size limitation of the logo or a desired location (front vs. back side) we should consider? The website is not loading the PAAB logosheet PDF unfortunately? Currently, the PAAB logo must appear in both […]
When PAAB approves a submitted piece, it provides an approval identification number. Can you advise me as to the configuration of that number? How many characters is it? Is it an alpha-numeric configuration? We are formatting a cloud-based internal review system and would like to capture our PAAB approvals accordingly. Thank you. Currently, our PAAB […]
If we were to develop an unbranded DTC help-seeking ad (in which the pharmaceutical sponsor WOULD NOT be disclosed) – can the ad link to a DTC, disease-state website, in which the pharmaceutical sponsor IS disclosed? The disease-state website has been previously approved by PAAB. A tool meeting all the requirements of a Help-seeking announcement […]
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. No. The piece need only contain the indications relating to the promoted uses. Note that some […]
Is there a preference as to which comes first after a claim: the symbol (e.g. *) or the footnote number (e.g. 1)? “My product was tested and found to work.”*1 or “My product was tested and found to work.1* Should these be superscripted or just keyed in in a regular font (e.g. *) Is there […]
It seems to be standard industry practice to post the Product Monographs for pharmaceutical drug products on the corporate websites. There are no ancillary messages provided with these, just the links to the full texts of the product monographs. In addition, these PMs are available through Health Canada’s Drug Product Database to anyone who searches, […]
Are unbranded printed materials focussing on disease area with no mention of drug treatments and that are presented to Health Care Professionals by Sales Representatives exempt from PAAB review? It is exempt if ALL of the following are true: there is no mention of healthcare products (by name, class, or category) no drug issues are […]