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. Miscellaneous
  4. 552 - In the indication for a product has been updated (ie. expanded), can you put a "New" sticker on the front page of the Product Monograph for distribution to HCPs?
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.

552 - In the indication for a product has been updated (ie. expanded), can you put a "New" sticker on the front page of the Product Monograph for distribution to HCPs?

Scheduled Pinned Locked Moved Miscellaneous
1 Posts 1 Posters 248 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

    The product monograph is the Terms of Market Authorization approved by Health Canada. The document itself should not be modified outside of the regulatory process described on the Health Canada website (regarding the processes for each level of change). What you can do is generate a promotional monograph. Promotional monographs should not be labeled as “Product Monograph”; they should be identified as advertising/ promotional systems (APS) with titles similar to “Promotional Monograph”, “Marketing Monograph”, or “Clinical Monograph” and reviewed to approval by the PAAB. Please see Guidance on Promotional Monographs document on the PAAB website (http://www.paab.ca/advisories-guidance.htm) for more information. Note that “new” is a broad and unclear statement. What is new? Is it the product? Is it an indication? Is it a dosage form? Etc… During the PAAB review process, PAAB will ensure your promotional monograph is aligned with the PAAB code.

    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