233 - Cosmetics are not in the scope of the PAAB code unless they are medicated or hypoallergenic. I assume that any medicated have a DIN or NPN. Is this also true of products with a hypoallergenic claim? We have a Cosmetic (no DIN, no NPN)in our portfolio that the company wants to detail to HCP. As such, HCP specifc promotional material is being created. Despite the fact that cosmetics without a DIN or NHP are outside the scope of PAAB, does the fact that the promotional material is directed to HCP mean it should be reviewed by PAAB or would this still fall under ASC? Thank you for your assistance.
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For the purpose of the PAAB Code, cosmetics (as defined in the Food and Drugs Act and Regulations) are excluded from the definition of "Healthcare Product" and therefore do not fall within the scope of PAAB preclearance. Therapeutic claims cannot be made for such cosmetics AND all cosmetic claims should be aligned with the Health Canada guidance document " Guidelines for Cosmetic Advertising and Labelling Claims".Note that therapeutic cosmetics, e.g. medicated and hypoallergenic preparations, are classed as pharmaceutical products. Advertising/Promotion Systems (APS) for such products must be submitted for PAAB review and clearance.
