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  4. 347 - Is the message "Now Approved" acceptable in APS? It seemed that at one time, this was discouraged due to the perception of Health Canada endorsement

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347 - Is the message "Now Approved" acceptable in APS? It seemed that at one time, this was discouraged due to the perception of Health Canada endorsement

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    You are correct. It is generally not accepted as it suggests Health Canada endorsement. This is an application of section C.01.007 of the Food and Drug Regulations which was requested by Health Canada. I said "generally" because there are two exceptions which readily come to mind. On occasion, the wording "approved" appears within a product's Terms of Market Authorization (TMA). In those instances, we accept the message with the same context & emphasis as the TMA. "Approved" / "Approval" can also be considered when its context is limited to formulary coverage.

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    • M Offline
      M Offline
      Maryssa
      wrote on last edited by
      #2

      Hi PAAB team,

      I understand that "Now Approved" is not compliant. However, is "Now Authorized" an approvable alternative?

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      • D Offline
        D Offline
        dmauri
        wrote on last edited by
        #3

        @Jennifer-Carroll @Maryssa My understanding is that "authorized" is accepted, while "approved" is generally not accepted. This is based on PAAB forum topic 191 (PAAB Q&A 501)

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        • Jennifer CarrollJ Offline
          Jennifer CarrollJ Offline
          Jennifer Carroll
          wrote on last edited by
          #4

          Hello @Maryssa

          Q&A 501 is exactly the one we would have pointed to @dmauri 👍 . However, the copy "Now authorized" alone is incomplete (authorized how? for what?) it should be restricted to "Authorized for use in..." or "Authorized for sale in ...".

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