How to communicate transition to NOC from NOC/c
-
If a product was previously approved with NOC/c and is expected to receive NOC after Health Canada has reviewed the completed phase 3 trial, can the new status of NOC be used as a sort of marekting benefit claim. Something similar to 'Product X now has NOC after completion of their pivotal trial', followed by an informative section on the difference between NOC/C and NOC? Could this also be something that is created as a sticker to go on existing materials overtop of the NOC/c disclaimer, or elsewhere on the piece.
-
If a product was previously approved with NOC/c and is expected to receive NOC after Health Canada has reviewed the completed phase 3 trial, can the new status of NOC be used as a sort of marekting benefit claim. Something similar to 'Product X now has NOC after completion of their pivotal trial', followed by an informative section on the difference between NOC/C and NOC? Could this also be something that is created as a sticker to go on existing materials overtop of the NOC/c disclaimer, or elsewhere on the piece.
Hey @smurcar
We cannot provide a review over the forum. Claims around the approval process are generally restricted to factual statements about the current state of the approval. Note that it is not acceptable to promote the approval process in branded advertising per Food and Drug Regulations C.01.007. See this previous Q&A.
In reference to the sticker approach, we suggest submitting an opinion with the content you intend to use and the positioning on pieces (with examples) so that we may assess in the context of a complete picture. Given the outlined copy provided, it appears it may be appropriate to use a sticker to update pieces. The full review would cover the requirements for the copy on the sticker and the copy which would become covered on the revised pieces. We’d also need to assess if anything else changed in the TMA that may affect the piece beyond just the NOC status change.
