Patient Images in HCP and Patient Materials

[Supraja]

Hello PAAB,

Are we allowed to use real patient images in patient and HCP materials, including images of patients from clinical trials (for newly approved products)? Do we need to include any disclaimers such as "Actual Product X patient" or "Not a real patient" depending on images used?

[Jennifer Carroll]

Hi @supraja

In general, actual patient images may be used in HCP materials. Please see the following PAAB Forum post Q&A for additional details. For patient materials, actual images may also be used with a disclaimer when consistent with part 3 of the product monograph but with a caveat. Patient materials may not contain promotional claims as per code section 6. Patient images will not be accepted if they are determined to be promotional.