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659 - As per the PAAB Code section 1.8 Definitions, the New Healthcare Product is defined as follow: "Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years". It is our understanding that for any APS we are limited to one year of usage of the word "New" from initial marketing. However, please clarify, what is the less than two years period in the above statement for the “New Healthcare Product" is referring to?
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Please note that the complete definition for New Healthcare Products reads "Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years. Use of the word "new" or statements implying "new"; in advertising should be restricted to 1 year after initial marketing"; The portion relating to 2 years relates to a category threshold used by Health Canada for administrative purposes. It has no bearing on drug advertising. The 1 year provision comes from case law and is reflected in several codes and guidances within this industry and others.
