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 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:

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

On September 16, 2020, the Minister of Health signed the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. This interim order introduced a pathway to review Drug Establishment Licence (DEL) applications in an agile and expedited manner.

To submit a DEL application in relation to a COVID-19 drug under this interim order, please include "COVID-19 DRUG INTERIM ORDER" in the email subject line. Further information on DEL application requirements under the interim order can be found within the guidance document .

Should you wish to request an expedited review of a DEL application not submitted under the above interim order, 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 submission.
  • Limit the scope of your DEL application to the medically necessary drug or the drug that is important for mitigating COVID-19 risks.
  • Clearly indicate the following in the cover letter of your application:
    • brand name of the drug
    • drug identification number (DIN)
    • active ingredient(s)
    • reason for requesting an expedited review

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 hc.del.questions-leppp.sc@canada.ca and include "COVID-19" in the subject line.

Issuing drug establishment licences electronically

In April 2020, we implemented the electronic issuance of DELs via email with electronic signatures (e-DELs). We will no longer be sending paper copies of DELs by mail. This new process helps ensure critical business lines, such as drug establishment licensing, can be carried out with minimal delays for regulated parties.

To prevent issues with obtaining your e-DEL or other electronic documentation, DEL holders must notify Health Canada if contact information in the DEL application has changed. This includes e-mail and mailing addresses. You can update the company contact information by filling out the drug establishment licence application (FRM-0033) and emailing it to hc.el.applications-le.sc@canada.ca.

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