99 - Does PAAB have specific rules regarding Pre-NOC communications
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Are you allowed to send out a pre-NOC communication that focuses on the disease, patients current unmet need and that a new option for treatment is coming soon?
PAAB has had a guidance on pre-NOC review of communications since 2003. It is posted on the PAAB web-site www.paab.ca. This type of message usually falls into "editorial" advertising and you should refer to the second paragraph of 7.6.1. Federal law and PAAB code section 3.1 prohibits advertising of a health product prior to Health Canada approval for marketing. Therefore, you cannot point to a "new option" or any other wording that depicts a specific product. You can speak to the disease and to some degree "patient's unmet needs" but not if it is disparaging to current therapy or points at a specific alternative. For new projects, I suggest calling the PAAB office and ask for a verbal opinion at no charge regarding the need for PAAB review.