NOC/c box without indication
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Hi, I understand that NOC/c product materials have to have the text "PRODUCT has been issued conditional marketing authorization pending the results of studies to verify its clinical benefit. Patients should be advised of this conditional marketing authorization."
My question is- does this text always have to be accompanied by the indication or can there be PAAB exempt pieces where only this text is there and no indication? Thanks! -
Hi, I understand that NOC/c product materials have to have the text "PRODUCT has been issued conditional marketing authorization pending the results of studies to verify its clinical benefit. Patients should be advised of this conditional marketing authorization."
My question is- does this text always have to be accompanied by the indication or can there be PAAB exempt pieces where only this text is there and no indication? Thanks!Hi @gbrl88
The NOC/C box should be accompanied by the full indication as per the respective product monograph. Please see our guidance document regarding NOC/C requirements in advertising, Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOC/c. Please also see PAAB Q&A 619 regarding potential exempt messages with an NOC/C product.
