174 - Dear PAAB: Does inclusion of a product Name, and its associated DIN, adhere to name/price/quantity guidelines in c.01.044? Does package size (i.e. weekly, monthly and number of tablets) meet the regulations for quantity? Many thanks.
Jennifer Carroll last edited by
Including the DIN in a reminder ad for a prescription drug directed to consumers does not adhere to the letter and spirit of Section C.01.044 of the Food and Drug Regulations. As you may be aware, reminder ads are acceptable provided that there is no allusion or link to the therapeutic indication of the advertised product. However, as it is often the case with reminder ad campaigns, market authorization holders set up a branded prescription drug Web site where patients who have been prescribed the prescription drug can enter the DIN in order to get access to the full product information. This practice has been deemed acceptable by Health Canada as it acts as a mechanism to restrict access to patients, and not the entire general public. Therefore, in such a scenario, providing the DIN in a reminder ad would likely constitute a direct-to-consumer advertising in contravention of Section C.01.044. With respect to your question about package size, we would suggest that you restrict the quantity claim such that it relates to the number of units provided for the price, as this will provide accurate information as to the unit price. If your question is more related to product package representations, we invite you to consult the Health Canada policy entitled "Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers" available at: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/notice-avis_reminder-rappel-eng.php.