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:

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:

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.

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