251 - The Code (in part) states: 1. that patient information is exempt from PAAB review if the information is direct from and consistent with the product monograph. 2. patient materials must be non-promotional. The questions, • if by PAAB's interpretation, would the content of PART III of a product monograph be exempt if produced in a multipage brochure layout, accompanied by product branding elements (colors, graphic design, brand logo, etc). • if a brochure layout is acceptable, then may the formatting be comparable, or are there restrictions or requirements related to formatting treatments for section titles, italics, bolded fonts, underlined text, etc.
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Distribution of part III of the PM would not require PAAB preclearance.
Modification (e.g. removal of content, insertion of text/visuals) made to the document for distribution to patients through HCPs would require PAAB even if the resulting document meets the PAAB code 6 requirements for consistency with part III & non-promotional content/tone. Indeed, PAAB pre-clearance is intended to ensure that these requirements are met. Call me at the PAAB office if you'd like to discuss your specific case.
