Skip to content
  • Categories
  • Recent
  • Tags
  • Popular
  • Users
  • Groups
Skins
  • Light
  • Cerulean
  • Cosmo
  • Flatly
  • Journal
  • Litera
  • Lumen
  • Lux
  • Materia
  • Minty
  • Morph
  • Pulse
  • Sandstone
  • Simplex
  • Sketchy
  • Spacelab
  • United
  • Yeti
  • Zephyr
  • Dark
  • Cyborg
  • Darkly
  • Quartz
  • Slate
  • Solar
  • Superhero
  • Vapor

  • Default (No Skin)
  • No Skin
Collapse
Brand Logo

Forum

  1. Home
  2. PAAB Q&A
  3. Terms of Market Authorization
  4. 106 - If the US indication is the same as the Canadian one, but the US Product Monograph is more comprehensive can it be cited instead?
PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

106 - If the US indication is the same as the Canadian one, but the US Product Monograph is more comprehensive can it be cited instead?

Scheduled Pinned Locked Moved Terms of Market Authorization
1 Posts 1 Posters 155 Views
  • 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 CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    PAAB Code section 3.1 states that all claims must be consistent with, and within the limitations of, the Health Canada approved Terms of Market Authorization (TMA) (e.g. product monograph). The US FDA approved Product Monograph would not meet that requirement even if the product's indication is similar in Canada. Question #56 may also be of interest as it is similar to this current question.

    1 Reply Last reply
    0
    Reply
    • Reply as topic
    Log in to reply
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes


    • Login

    • Don't have an account? Register

    • Login or register to search.
    • First post
      Last post
    0
    • Categories
    • Recent
    • Tags
    • Popular
    • Users
    • Groups