Pharmaceutics (ICS 11.120)
Notice of Proposal to expand lists of certain products for distribution as samples and a list of certain non-prescription drugs for which testing requirements do not apply (8 pages, available in English and French)
Health Canada intends to amend the lists for non-prescription drugs set out in the Canada-United States-Mexico Agreement (CUSMA) that meets the identified criteria, i.e., for topical use, localized and non-systemic effect, and meets the definition of a cosmetic.
The product categories that meet these criteria include: toothpastes, mouthwashes, anti-septic skin cleansers, sunscreens, anti-dandruff products, diaper-rash products, medicated skin care products, acne therapy products and antiperspirants, as well as athlete's foot products and throat lozenges.
Health Canada is proposing that within those products categories, all lists for non-prescription drugs will be expanded to include all approved ingredients, all approved quantities and all approved uses or purposes with the exception of certain medicated skin care products. The CUSMA does include some exclusions related to medicated skin care products (i.e., antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics), and these exclusions will be maintained for the current proposal. Health Canada's proposal also includes updates and revisions to the list of certain non-prescription drugs for which additional (i.e., identity and confirmatory) testing is not required upon importation and that may be directly shipped to retailers or wholesalers. Health Canada intends to expand the list of certain non-prescription drugs for which testing requirements do not apply. Thus expanding the list toinclude all approved ingredients, all approved quantities and all approved uses or purposes with the exception of certain medicated skin care products.