Question 234

Can a company display disease state educational materials at a booth at a conference in which the company does not have any marketed compounds (i.e. a disease awareness booth)?
Once the product is approved, the manufacturer may continue to use the same visuals/colours from prior editorial pieces in branded APS ONLY if the pre-NOC content falls within the limitations of the approved product's Terms of Market Authorization (TMA). Otherwise, using the same visuals/colours would link the product to disease information which extends beyond the limitations of the TMA thus contravening PAAB code section 3.1 and possibly the Food and Drugs Act section 9.1. The PAAB urges pharma companies to approach the decision to use future branding elements in pre-NOC unbranded pieces with caution as the final TMA is not known with certainty prior to product approval. It is possible that you may not be able to use visuals post-NOC if they were used in pre-NOC pieces that contained disease information or content which extends beyond the limitations of the final/approved TMA (e.g. due to unforeseen revisions requested for the PM). If the pharmaceutical company is uncomfortable with this possibility, we would advise against using the planned future branding visuals within pre-NOC APS. Note that use of visuals/designs prior to NOC which already exist in other jurisdictions in association with the brand would appear to be an indirect promotion of an unapproved product. This would contravene section c.08.002 of the Food and Drug Regulations. See question & answer #102 for discussion on acceptable pre-NOC content and see Q&A #107 for discussion on acceptable references in pre-NOC pieces. Call the PAAB office if you have specific questions about pre-NOC APS.

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