520 - Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?
Jennifer Carroll last edited by
No. The Canadian advertising regulations (including the PAAB code) do not apply to materials presented at international conferences as long as ALL of the following provisions from the Health Canada policy document “The Distinction Between Advertising and Other Activities” are adhered to:
• the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions,
• the material must emanate from the parent company of the manufacturer,
• the material must only be for use within the confines of the conference, and
• the material is prominently identified as not being authorized for sale in Canada
Note, that the disclaimer must be modified in your case as the product is indeed authorized for sale in Canada. I elaborating a bit on the disclaimer you are proposing in your question. Specifically, I suggest prominently conveying that all the information comes from the US labelling/Marketing Authorization AND that this information is not consistent with the Canadian labelling/Market Authorization.