116 - We want to produce a sticker that will say : NEW INDICATION. This sticker will be distributed to representatives to be applied on several promotional items that have gone through the PAAB for approval. Does this sticker need to go through PAAB for approval?
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The claim "New indication" does not meet any of the PAAB exemption criteria listed in section 1.5 of the Code. The sticker would therefore require PAAB review. As part of our review, we would require to know which APS the sticker will be applied to (and where within those APS it will be applied). Please note that the PAAB would not accept addition of a sticker stating only "New indication" to APS which do not contain the new indication as this would be unclear. The pieces would be required to contain that indication. Additionally, it would need to be clear which of the indications are "new". For scenarios in which the approved APS does not already contain the new indication, we would require that the sticker itself contain the full indication. Advertising must be accurate, complete and clear as per section 2.1 of the PAAB code. If you have any further questions about this, please call the PAAB office.
