How much time does MAH have to update the existing PAAB approved APS that are still effective after a new version of Product Monograph has received NOC. Please see Q&A 377, 485 and Update of APS per new boxed warning in PM.
Can a Pharma company give t-shirts with product logo on it to their employees for their personal use? This would not fall under the scope of PAAB.
Question #497 – Patient video for product use on company website , has Health Canada provided a response? We have not received a response to date. We will pose the question to them again. Thank you for the follow-up.
Hi Patrick – I've read the 2019 Client Survey report on the PAAB website. Is there a plan to disseminate this more broadly, and what actions is the PAAB taking with regards to any of the specific survey results? Thank you. The 2019 Client Insight research has been posted to the PAAB website and is […]
Can you please confirm that use of a drug name along with its pharmacologic classification (eg. 'diuretic') is exempt from PAAB review? The therapeutic classification (eg. 'antihypertensive') would not be included, as this alludes to therapeutic use. Please see answer to Question #467.
Understanding that Help-Seeking messages can not include the sponsor, what if a message was broad enough not to allude to a single product? eg. “Ask your doctor about CV medications from Company-X”. This would still be considered a help-seeking message and create a link between a condition and the sponsor. It is not acceptable to […]
We are in the early stages of planning a website for use by healthcare professionals and patients (gated appropriate for each) to access disease and product information for multiple therapeutic areas. For convenience, we wish to create on the ungated home page a link to a portal (also gated) housing accredited CHE for healthcare professional […]
We have an HCP piece approved by PAAB to be used as a print Leave-Behind. We would like to use a part of the content (unchanged) for a digital advertisement. Does is require to be submitted to PAAB as a new file? Yes. PAAB reviews pieces in their entirety. Reproduction of part of a piece […]
Hi Patrick, I often find it easier to apply PAAB code when I understand the rationale behind it. But I have struggled to understand the blanket application of section 3.1. In many instances, the PAAB requirement that claims remain “within the limitations of the TMA” makes sense – specifically when “beyond the limitations” is also […]
For advertising a Rx or OTC drug to HCPs, could we add more safety information such as contraindication, warnings…beyond what is in the approved TMA? considering that it is for safety reason e.g. contraindicated in asthma patients (but not stated as such in the TMA). This would be based on a published study or guidelines. […]
What are the rules regarding using similar graphic symbols for branded PAAB approved promotional pieces addressed to HCPs and branded DTC materials for the same OTC product. Is it acceptable that they have the same graphic elements such as icons to illustrate the approved claims/indications? The link created by using the same visuals (including but […]
Can a patient survey be used to support claims of ease of use? Would it make a difference if the prescription product were administered through a Class-II medical device? A survey can be considered for use to support non-clinical product claims such as taste, smell or attitude regarding easy of administration if it is deemed […]