To be clear, with exception of advertising for Class B Opioids and a growing list of NOC/c products, preclearance is not mandated by Health Canada. Instead, Health Canada strongly recommends advertising preclearance by a recognized independent preclearance agency to ensure that advertising materials in all media comply with the Food and Drugs Act, Controlled Drugs and Substances Act, and respective regulations. It is important to note, however, that advertising preclearance is a requirement of the PAAB Code.

Per sections 1.3 and 1.4, the PAAB Code applies to all healthcare professional directed Advertising / Promotion Systems (APS) relating to the product types outlined in the definition for “healthcare products” within section 1.8 of the Code.  For any APS that falls within the scope of the Code, distribution or dissemination prior to preclearance contravenes the PAAB code unless those APS are expressly identified as exempt from preclearance in section 1.5 of the Code.  There are no exemptions based on media and no exemptions based on membership status with any trade association.

Some are surprised to learn that the PAAB Code requirement for preclearance even applies to unbranded APS.  With respect to editorial advertising, PAAB Code section 7.5 states "All such materials must be submitted for preclearance prior to distribution to health professionals". With respect to corporate advertising referring to a healthcare product, PAAB Code section 7.4 states that they "... must be submitted for PAAB preclearance prior to publication".

October 6, 2022