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Please call the PAAB office (905) 509-2275 and ask for Glenn Golaz. He will register you on eFiles. We register individuals on behalf of companies. Afterwards, our file coordinators can help you if you have technical questions about submitting the projects.
The claim "New indication" does not meet any of the PAAB exemption criteria listed in section 6.6 of the Code. The sticker would therefore require PAAB review. As part of our review, we would require to know which APS the sticker will be applied to (and where within those APS it will be applied). Please note that the PAAB would not accept addition of a sticker stating only "New indication" to APS which do not contain the new indication as this would be unclear. The pieces would be required to contain that indication. Additionally, it would need to be clear which of the indications are "new". For scenarios in which the approved APS does not already contain the new indication, we would require that the sticker itself contain the full indication. Advertising must be accurate, complete and clear as per section 2.1 of the PAAB code. If you have any further questions about this, please call the PAAB office.
Can you confirm for branded, paid search campaigns, if you're able to:
The keyword would trigger a branded text ad that would then link to a DIN-protected, branded site.
Answer 1: Section C.01.044 of the Food and Drugs Regulations prohibits Schedule F product promotion directly to consumers beyond name, price, and quantity. As such, linking product name and condition in this manner would appear to contravene the Food & Drugs Regulations.
Answer 2: The term "Corticosteroids treatment" would also exceed the name, price, and quantity restriction.
Ensure that the search results, the meta data descriptor, the site URL, and/or the content visible on the splash page (prior to entry of the password) do not exceed the name/price/quantity restriction. Please call the PAAB office if you require further information.
We would need more information to answer this. The answer would depend on the following:
If the promotional material is directed to HCPs, the PAAB reviews the content irrespective of the medication's Federal schedule (i.e. whether the product is a prescription, non-prescription, or a natural health product). If the material is directed to consumers in the waiting room, the PAAB would review the messaging for prescription drugs and schedule D drugs.
The PAAB would not review claims about the device itself if "the system" had been approved by Health Canada as a medical device. Please call the PAAB office if you have any questions or require further information for your specific case.
If all copy, relative positioning, and relative size are identical, we can review all sizes within a single eFile. For post-approval re-sizing, the ad should be provided to PAAB as an FYI ("For Your Information") such that we can have the various versions on record.
Advertising displayed in the waiting room would be considered direct to consumer advertising. Direct to consumer advertising of OTC and NHP products fall within the jurisdiction of Advertising Standards Canada (ASC). We suggest contacting ASC at 416-961-6311 (http://www.adstandards.com/en/). Note, however, that patient information for an OTC or NHP product involving the health care professional as an intermediary would require PAAB review under code section 6.4.3.
The PAAB provides advisory comments on vaccine and prescription direct-to-consumer advertising or information materials.
If a client was to state its indication along with a logo on an electronic web banners, does it needs to be approved by PAAB? As well, does it need to have a click through to PAAB?
The ad is required to be reviewed by the PAAB. The PAAB code section 6.6.d states that an ad containing only the drug name in a context not linked to a therapeutic message in any way is exempt. The indication would be considered a therapeutic message. I am unsure what you mean by "click through to PAAB". I will assume you had meant "click through to the prescribing information (PI)". Yes, a link to the PI would be required if the APS does not meet the reminder ad criteria listed in PAAB code 7.4. Also note that if the reminder ad criteria are not met, additional fair balance would be required to appear on the ad itself. If the "logo" contains a claim (whether text or visual) the ad will not meet reminder criteria. If I have misinterpreted your question, please do not hesitate to call me at the PAAB office.
We would like to develop a schedule table for a multi-dose regimen of a vaccine and provide it to customers in a fridge magnet format. No product name or branding will be included, but it will be labelled as being provided as an educational service by company X. The content would be submitted for PAAB review.
Is the fridge magnet format acceptable to PAAB?
The PAAB reviews drug advertising content. We do not rule on marketing practices. We have previously approved advertising messages on fridge magnets. Pease note that a product's dosing information is considered claim copy. It will be required to be consistent with that product's terms of marketing authorization (TMA) and it should be accompanied by the indication and balancing information.
Prior to considering providing items as a giveaway, we strongly urge you to check with the Rx&D Code of Ethical Practices s11. We have a link to Rx&D on our website (www.paab.ca/).
The Customer Experience Index surveys are sent by automated software in a random manner and are anonymous to PAAB personnel. For ease of administration they are sent to the admin staff who initiated the eFile. However, there is no reason why the firm receiving the survey cannot pass it on to whomever they deem it best to complete the survey. The PAAB requests an answer from the person or group of people who had the most experience on the particular file in question.
The PAAB code says that we cannot refer to Health Canada or the approval process for drugs in our advertising, and the reasons are obvious.
But why can't we say "for all approved indications" when a product has a number of different indications?
Health Canada has asked the PAAB to ensure that the approval process is not discussed in drug advertising. The PAAB therefore questions the claim "approved" whether it is used in conjunction with the product name or the indications. The underlying principle is to avoid implying an endorsement for the product or its individual indications. Also note that C.01.007 of the Food and Drug Regulations states that "no reference, direct or indirect, to the Act or to the Regulations shall be made Â… in any advertisement for a drug unless such reference is a specific requirement of the Act or Regulations".
Have you considered simply "for all indications" or "for all authorized indications" (i.e. given that they stem from the Terms of Marketing Authorization)? Please call the PAAB office if you desire more direction on your particular claim.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
