459 - I'm working in a branded patient-information brochure that includes disease information and dosing. All the content is consistent with part III of the TMA. Does this piece require fair balancing copy? If so, what information is required in the fair balance for patient pieces?
Jennifer Carroll last edited by
With regards to when risk information is required in a patient information piece, refer to page 3 of the following document: http://www.paab.ca/resources/pdfs/code-revision/External_Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf
With regards which information is required as general risk disclosure, any content emphasized in part III of the TMA (e.g. appearing boxed or bolded) and any content and an HCP (e.g. physician or pharmacist) would be particularly compelled to warn a patient about. It is a best practice to include part III of the TMA (or a link to it) with the piece.