629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks
Jennifer Carroll last edited by
The following guidance is provided under the assumption that this is the entire content of the piece. The Food and Drug Regulations prohibit discussion of the approval process within advertising. If we were to reframe the question to a message of “Now available in Canada”, while the message itself would be considered exempt from PAAB review, it is still advertising and subject to the standards of the PAAB code. Messages of “new” are restricted to one year post marketing. Stating that the product is “now available” without limiting the claim to the new 2nd indication, would be misleading. The 2nd indication would need to be included to accurately limit the ”new” claim and this would render the piece non-exempt. See code section 1.5D for a list of exempt messages.