Question 591

HI PAAB, when a drug goes from pre-NOC to NOC, is it possible to use the wording "Now Approved In Canada". Also, if this is marketed to general population, does it need PAAB approval? Thanks
Hi, I'm sending this request for clarification on the new PAAB code: section 3.1.6 of the new code states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. compared to the previous code which states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of the indications or dosage of a product must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. can you please clarifiy the implications or give examples on how the new point 3.1.6 differs from the old one? thank You!

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