Cluster Updates

Fast Track COVID19 Product Production

9/5/2020

Hand Sanitizer Regulations

Regulation - First Step is to get the product notification complete. The following is from the Health Canada Program

Note that in order to be eligible for a Notification process, the product itself needs to be registered in a PIC/S or MRA country (e.g. FDA registration number for the product_NDC). In addition, the medicinal ingredients should be captured by the HC’ monograph for antiseptics.

Also note that the foreign label should be used for product imported under the Notification stream and that the only adjustments allowed are:

Addition of the importer name (imported by XXX)
Translation if desired or if not in French or English)

The summary of the process below:

If you import a hand sanitizer containing ethanol or isopropanol (Natural Health Product), proceed as follows:

If the product has a recognized registration number
Submit a cover letter and a Site Licence Application to NNHPD using e-Post (consult the guide provided to obtain a company code and create an e-Post account).
When you have your Site Licence number, submit the filled level 2 Notification form to hc.covid19healthproducts-produitsdesante.sc@canada.ca with the product label and the proof of registration in a PIC/S or MRA country.

If the product doesn’t have a recognized registration number,
Submit the cover letter where you select “both product and site Licence Application” and theProduct Licence Application Web form using e-Post to NNHPD (consult the guide provided to obtain a company code and create an e-Post account).

In addition, please confirm on the Notification form that the grade of alcohol used in the product is pharmacopoeial or food grade. Consult the attached document "Interim guide on the production of ethanol for use in alcohol based hand sanitizers".

If the product is not imported but manufactured in Canada, a Site Licence and a Product Licence (NPN) are required.

cover_letter_for_interim_approach_to_hand_sanitizers_with_import.docx
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guide_on_health_canadas_interim_expedited_licencing_approach_for_the_production_and_distribution_of_alcohol_based_hand_sanitizers.pdf
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