Drug establishment licences and COVID-19

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What is a drug establishment licence

All Canadian drug establishments must have a drug establishment licence (DEL) to fabricate, package/label, distribute, import, wholesale or test a drug as required under Part C, Division 1A of the Food and Drug Regulations. For more information, please refer to the following guidance on drug establishment licensing.

A drug establishment licence is not required for Natural Health Products that are subject to site licensing requirements.

Changes during COVID-19

Modified drug establishment licence operations

Health Canada is working closely with the Public Health Agency of Canada, which is leading the COVID-19 public health response and pandemic planning. In addition, we are working with our provincial, territorial and international partners to monitor and respond to this evolving situation. 

Our focus at this time is on the critical services related to protecting the health and safety of Canadians during the COVID-19 pandemic.

As such, priority is given to DEL applications that support the response to the pandemic, including applications for activities related to the following drugs:

Expediting applications for drug establishment licences that support the response to COVID-19

The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD Interim Order) introduced an agile and expedited pathway to review DEL applications submitted in relation to COVID-19 drugs. The ISAD Interim Order expired on September 16, 2021. However, given the ongoing public health need for COVID-19 drugs, certain provisions of the ISAD Interim Order were transitioned to the Food and Drug Regulations.

When applying for a new or amended DEL for a COVID-19 drug (a drug represented for use in relation to COVID-19), please include the following information:

  • COVID-19 Drug” in the subject line of the email application
  • statement in the body of the application email or cover letter that the DEL application is only for a COVID-19 drug
  • name of the drug

For more information, please refer to the following guidance document:

We will also continue to expedite the review of applications for medically necessary drugs and other drugs considered important for treating and preventing COVID-19. Please follow the instructions below when submitting your application:

  • Include the term "COVID-19" or "Medically Necessary" (whichever is applicable) in the subject line of your email application.
  • Limit the scope of your DEL application to the medically necessary drug or the drug that is important in mitigating the risks of COVID-19.
  • Clearly indicate the following in the cover letter of your application:
    • name of the drug
    • drug identification number (DIN), if available
    • active ingredient(s)
    • reason for requesting an expedited review (for example,potential drug shortage)

We have established flexible measures for submitting evidence of compliance to good manufacturing practices for foreign buildings.

For enquiries about drug establishment licensing related to COVID-19, email del.questions-leppp@hc-sc.gc.ca and include "COVID-19" in the subject line.

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