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203 - Hello, i am looking for an official definition of on-label as it relates to conversations that a pharma rep can have with a HCP. Although all material need to be PAAB-approved, verbal exchange in the office can touch on latest data publicly available, such as posters, conference reports, etc. If referring to approved dosage, patient population and condition, can the reps discuss this with physicians in an effort to have robust clinical and scientific discussions... best regards
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"On-label" is equivalent to "consistent with the Terms of Marketing Authorization (label, product monograph, product license) that has been approved by Health Canada." See PAAB Code s3.1. Verbal discussions by sales reps are covered by the Food & Drugs Act and Regulations. Therefore, a representative can talk about new studies that are not part of the product monograph if the content is consistent with the indications, dosing, and degree of efficacy and safety stated in the Product Monograph. Rule of thumb - if the PAAB would not approve the information in a print piece, the rep should not be promoting that information verbally. Also see Innovative Medicines Canada Code of Ethical Practices
