Changes made to list of non-prescription drugs: Notice of modification

Date: October 28, 2022

Health Canada's Regulatory Operations and Enforcement Branch has amended the following list:

• List of non-prescription drugs for which the testing requirements set out in subsections C.02.019 (1) and (2) of the Food and Drug Regulations

Health Canada posted the notice about the proposal to modify the list of non-prescription drugs on August 11, 2020. A 60-day comment period followed. Health Canada reviewed and considered all comments received.

Within the product classes set out in the Canada-United States-Mexico Agreement, Health Canada has expanded the list of non-prescription drugs. The list now includes all approved ingredients, quantities and uses or purposes for all non-prescription drugs except medicated skin care products.

Product classes covered are:

• sunscreens
• toothpastes
• mouthwashes
• antiseptic skin cleansers
• anti-dandruff products
• diaper rash products
• medicated skin care products
• acne therapy products
• antiperspirants
• athlete's foot products
• throat lozenges

Health Canada is currently updating the following guidance document:

• Annex 7 to the Good manufacturing practices guide for drug products – Selected non-prescription drugs

This change is effective as of October 28, 2022.

Contact us

Regulatory Operations and Enforcement Branch (ROEB)
200 Eglantine Dr
Address Locator 0900C2
Ottawa ON K1A 0K9
Email: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca