Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer: Purpose and scope

This document provides instructions for manufacturers and sponsors applying for a Drug Identification Number (DIN) for hand sanitizers that:

• contain a non-prescription drug ingredient and
• are fully supported by Health Canada’s Antiseptic Skin Cleansers (Personal Domestic Use) monograph (March 20, 2020)

This guidance clarifies our existing processes and guidance. It does not replace any information in those documents. For further information, consult our processes and guidance.

Note: Alcohol-based hand sanitizers with a single medicinal ingredient (either ethanol or isopropanol) are considered natural health products, not drugs. For such products, you do not need a DIN. You need a Natural Product Number (NPN) under the Natural Health Product Regulations to legally sell or distribute them. For details, please refer to Licensing approach to produce and distribute alcohol-based hand sanitizers: guidance document.

Hand sanitizers that contain a non-prescription drug medicinal ingredient may be supported by either:

• Health Canada’s Antiseptic Skin Cleansers (Personal Domestic Use) monograph (March 20, 2020) or
• a submission of additional evidence of safety, efficacy and quality, if the product is outside the scope of the monograph

This document provides simplified instructions for the first option only. For products outside the scope of the monograph, please refer to Guidance Document – Human-Use Antiseptic Drugs.