370 - We have a question related to the placement of formulary messaging on sample boxes. Is it acceptable to place a formulary sticker on a sample box? If so what kind of approvals would be required to permit this action?

  • Affixing something onto a product's outer box is a labelling concern. PAAB does not review and approve labelling. Health Canada regulates labelling. I'd consult the manufacturer's internal regulatory department for guidance on this matter. The answer would be significantly different if it related to affixing a sticker to a previously PAAB approved sample holder (i.e. an APS). Let me know if this is what you meant.