The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
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500 - Can you advise on PAAB's role/interpretation of 'drug delivery system' advertising? Examples wold be prescription drug inhalers, injectors, etc. Would advertisements focused solely on the delivery system/technology be exempt from PAAB (perhaps as a medical device), or seen as an extension of drug advertising (and reviewed in the same manner)?
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Class I, II, III, and IV medical devices are exempt from the provisions of the PAAB code (see sections 1 & 11 of the code). Claims in HCP advertising about drug delivery systems which are not classified as a medical device are subject to the PAAB code provisions (including the need for fair balance, evidence, clarity…etc.). Refer to the Medical Devices Active Licence Listing (MDALL) on the Health Canada website for Class II, III, and IV devices. You could also refer to the Medical Device Regulations (MDR) on the Government of Canada Justice Laws Website for provisions relating to the classification system.