Navigation

    Forum

    • Register
    • Login
    • Search
    • Categories
    • Recent
    • Popular
    • Users
    • Groups

    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?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
    1
    1
    156
    Loading More Posts
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes
    Reply
    • Reply as topic
    Log in to reply
    This topic has been deleted. Only users with topic management privileges can see it.
    • Jennifer Carroll
      Jennifer Carroll last edited by

      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

      1 Reply Last reply Reply Quote 0
      • First post
        Last post