317 - There seem to be some inconsistencies within the answers provided in this forum. In Question 313, PAAB replied that the indication does not constitute a 'claim' while in Question 303, PAAB stated that the indication is indeed a 'claim'. Could you please clarify your position. I'd argue that the indication is a claim as it refers to a therapeutic/ clinical effect.
Jennifer Carroll last edited by
An indication statement is a claim. BUT it does not (in and of itself) impact whether the highest, middle, or lowest level of fair balance is required. A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".