DIN Hand Sanitizers Now Require a Drug Establishment License
By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email
On March 20, 2020, Health Canada, recognizing the urgent need for hand sanitizers in Canada, implemented Interim Measures that would allow all hand sanitizers some temporary regulatory exemptions. These exemptions included Drug Establishment Licensing for licensable activities such as fabrication, packaging/labeling, testing, importing, or distributing a DIN registered product (drug product).
Health Canada has just announced they will be going back to normal pre-COVID-19 requirements effective September 1, 2021. As of this date, Drug Establishment Licenses will be required for all licensable activities for hand sanitizers that have a Drug Identification Number (DIN). These are for Non-alcohol Hand Sanitizers, such as those with Benzalkonium Chloride as the active ingredient. A six-month transition period is being afforded to allow the industry to adjust to the changes.
Drug Establishment License (DEL) Transition Period (March 1 – September 1, 2021)
If you conducted licensable activities for a designated hand sanitizer without holding a DEL under the Interim Measures, you may continue to conduct these activities for six months. If you apply for a DEL during the six-month transition period, you may continue to conduct the activities without a license for the specifically designated hand sanitizer(s) while Health Canada reviews your application. New DEL applicants must be ready for a Health Canada inspection when submitting an application as set out in the Good Manufacturing Practices inspection policy for drug establishments (POL-0011).
Remember, just as there are annual fees for you to maintain your DIN, there are fees associated with getting and maintaining a DEL. For example, effective April 2021, if you are the DEL holder and you import DIN Hand Sanitizer, your annual fee would be $28, 975.00 + $917.00 CDN for your foreign manufacturer (who is also required to be listed on your DEL and meet all applicable Drug GMP requirements).
If a DEL application is not received by September 1, 2021, you will be required to cease the licensable activities on that date.
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