Changes to drug establishment licence exemptions for hand sanitizers

Drug Establishment Licensing Bulletin 109, March 2, 2021

On this page

• DEL transition period, March 1 to September 1, 2021
• Applying for a DEL during the transition period
• Contact us

Health Canada is lifting flexibilities for drug establishment licences (DELs) established under the Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. A DEL will now be required to fabricate, package, label, test, import or distribute designated hand sanitizers. Industry will have a 6-month transition period to adjust to the changes.

Note: Designated hand sanitizers are classified as non-prescription drugs based on their active ingredients. Drugs categorized as surface disinfectants or natural health products do not require a DEL. For information on importing and selling natural health product hand sanitizers, consult the guidance document on site licensing.

DEL transition period, March 1 to September 1, 2021

If you conducted licensable activities for a designated hand sanitizer without holding a DEL under the interim order, you may continue to conduct these activities for 6 months after the re-issued IO came into effect. This takes you to September 1, 2021.

If you apply for a DEL (or apply to amend your DEL) during the 6-month transition period, you may continue to conduct the activities without a licence for the designated hand sanitizer while we review your application.

If we do not receive your DEL application by September 1, 2021, you must cease the licensable activities on that date.

Note: Importers and sellers of designated hand sanitizers must meet all applicable good manufacturing practice (GMP) requirements under the Food and Drug Regulationsthroughout the transition period.

Applying for a DEL during the transition period

When submitting a DEL application to continue conducting licensable activities for a designated hand sanitizer, consult the following guidance documents:

• Guidance on drug establishment licences (GUI-0002)
• Management of applications and performance for drug establishment licences (GUI-0127)

In your application, indicate the following:

• the DEL application is for activities conducted for a hand sanitizer while the interim order was in effect (in the email or cover letter)
• name of the hand sanitizer product for which licensable activities were conducted

Evidence requirements to support the GMP compliance of foreign buildings is included in the following guidance document:

• How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

Health Canada may consider other evidence on a case-by-case basis.

New DEL applicants must be ready for an inspection when submitting an application. These are set out in the Good manufacturing practices inspection policy for drug establishments (POL-0011).

Contact us

• DEL transition period or application requirements: hc.del.questions-leppp.sc@canada.ca.
• GMP requirements: hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca (put "COVID-19" in the email subject line)

Related links

• Food and Drug Regulations