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308 - HI there, Could you please elaborate on the exempt nature of personal correspondence (i.e. email between HCP and rep)? Under what conditions does that correspondence require PAAB review?
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Advertising to HCPs other than that covered in section 1.5 of the PAAB code requires PAAB approval. The PAAB code section 1.5 defines "personal correspondence as" single letters carrying a personal response or message. BUT it goes on to explain that this exemption does not apply to multiple personal letters initiated by the company. It is important to note that this code section only exempts a piece from the process of preclearance. Note that this section of the PAAB code only exempts a piece from PAAB preclearance, it does not necessarily exempt it from the advertising provisions in the Food and Drugs Act. For example, a drug rep sending an email to an HCP about off-label use of his/her product may be found to have contravened the Food and Drugs Act (even though it was only sent to a single person). Use the Health Canada policy document "The Distinction Between Advertising and Other Activities" to determine whether it falls under the advertising provisions. The section on "Unsolicited requests for information" will probably be particularly relevant to your question. Please do not hesitate to submit a written opinion to the PAAB if you'd like our thoughts on the specific activity you have in mind. Please refer to the fee schedule on our website wwww.paab.ca
