Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Drug establishment licences and good manufacturing practices

Drug establishment licences for COVID-19 drugs

Division 1A of Part C of the Regulations applies to COVID-19 drugs. A person must hold a drug establishment licence (DEL) authorizing any activities conducted with respect to COVID-19 drugs.

You can find the following information online:

how to interpret the Regulations for DEL requirements in the Guidance on drug establishment licences (GUI-0002)
your responsibilities related to the DEL application process and how Health Canada manages DEL applications in the document on the Management of applications and performance for drug establishment licences (GUI-0127)

For more information about drug establishment licences and COVID-19, see our page on drug establishment licences and COVID-19.

If you have questions about the DEL requirements or DEL applications for COVID-19 drugs, please email us at del.questions-leppp@hc-sc.gc.ca. Include the term "COVID-19" in your email subject line for a faster response.

Transitioning of DELs issued or amended under the ISAD IO

Stakeholders wishing to apply for a DEL or DEL amendment for a COVID-19 drug may continue to do so under the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO) until its expiry on September 16, 2021. For information on how to submit a DEL application under ISAD IO, please refer to the section on Drug establishment licences of the ISAD IO guidance document.

Applications that have been submitted under section 20 of ISAD IO and not issued before its expiry will be automatically transitioned. They will continue to be reviewed as though they were submitted under the Food and Drug Regulations. For such applications, DEL fees will not apply.

Notification

DEL holders who wish to maintain their licence, or part of their licence, that was issued under section 20 of the ISAD IO, must notify Health Canada before ISAD IO expires. We recommend doing so at least 30 days before ISAD IO expires.

To maintain a DEL issued under section 20 of ISAD IO, please submit the following information to Health Canada:

include "Maintain COVID-19 drug IO DEL" in the subject line of the notification email
include details indicating the notification is being submitted to maintain a DEL or part of a DEL issued for an application submitted under section 20 of the ISAD IO
include the application number assigned by the Drug Establishment Licensing Unit

Health Canada will review your notification to maintain and will inform you if more information is required.
Failure to notify us will result in the DEL being automatically cancelled, in whole or in part, when ISAD IO expires.

Applying for a new or amended DEL for a COVID-19 drug

This section is applicable after ISAD IO expires on September 16, 2021. For information on how to submit a DEL application under ISAD IO, please refer to the Drug Establishment Licences section of the ISAD IO guidance document.

New drug establishment licence (DEL) applications (C.01A.005(1)) or amendment applications (C.01A.006(1) (1.1)) for a COVID-19 drug can be submitted under the Regulations. Follow the standard process and use the most current version of the application form (FRM-0033).

When applying for a new or amended DEL for a COVID-19 drug, be sure to include the following information:

the subject line "COVID-19 drug" in the application email, which signals that this is a high-priority application
a statement in the body of the application email or cover letter that the DEL application is for a COVID-19 drug submitted under C.01A.005(2) or C.01A.006(1.1) of the Regulations
the name of the drug

Submit your completed application form by email to el.applications-le@hc-sc.gc.ca.

For more information on DEL requirements, please consult the following guidance documents on:

Issuance of a DEL for a COVID-19 drug

Health Canada issues or amends DELs in accordance with Part C, Division 1A of the Regulations.

COVID-19-related DEL applications submitted under the Regulations are processed in an expedited manner. Timelines for the expedited review are determined on a case-by-case basis. The materials submitted in the application and the volume of information to be assessed are factors in how quickly we can review the application.

For more information on the issuance of a DEL or DEL amendments, please consult the:

Guidance on drug establishment licences (GUI-0002)

DEL terms and conditions

This section is applicable after ISAD IO expires on September 16, 2021. For information on how to submit a DEL application under the ISAD IO, please refer to the drug establishment licences section of the ISAD IO guidance document.

At any time, Health Canada may impose or amend terms and conditions on DELs for a COVID-19 drug submitted under the Regulations. Decisions to impose or amend terms and conditions are based on the need to mitigate or manage additional oversight for risk-based reasons. These reasons include matters related to available evidence, medical necessity and activities conducted.

The ability to impose or amend terms and conditions gives Health Canada the agility to facilitate rapid access to COVID-19 drugs while mitigating risks.

Terms and conditions previously imposed on a DEL issued under the ISAD IO for a COVID-19 drug will continue to apply under the Regulations as necessary.

Every person who holds a DEL must conduct the licensable activities in accordance with the licence, and any terms and conditions imposed on it.

DEL holders that do not comply with the terms and conditions imposed on their licence will be subject to compliance and enforcement action for the contravention of s. 21.7 of the Food and Drugs Act. Such actions will align with the legislative framework and the principles outlined in our compliance and enforcement policy for health products (POL-0001).

DEL suspension and cancellation

Health Canada can suspend or cancel a DEL in full or in part for any of the reasons set out in sections C.01A.016 to C.01A.017.1 in order to prevent a risk to the health and safety of the consumer in relation to a COVID-19 drug. When a DEL is suspended or cancelled, the DEL holder must cease all suspended/cancelled activities.

For more information on DEL suspension and cancellation, consult the:

Guidance on drug establishment licences (GUI-0002)

DEL performance standards

DEL applications related to COVID-19 drugs will be prioritized and reviewed based on the:

public health need
materials submitted in the application
volume of information to be assessed

For more information on the performance standard, consult the guidance document on the:

Management of applications and performance for drug establishment licences (GUI-0127)

Drug establishment licence fees

DEL fees will be remitted for applications submitted under the ISAD IO until September 16, 2021. After that time, drug establishment licence fees will apply to the review of DEL applications submitted for a COVID-19 drug.

Please consult the guidance document on:

Fees for the review of human and veterinary drug establishment licence applications

Fees apply for the review of the following types of DEL applications:

an application for a new or reinstated DEL
an application for an amendment to add a domestic building to a DEL
an application for the annual licence review of a DEL

The DEL fee is calculated using the following components:

Domestic component: the fee charged for each building listed on the licence or application based on the most upstream activity at that building
Foreign building component: the fee charged for each unique foreign building (or building outside Canada) on the licence or application

Fees can be requested to be waived or reduced for applications filed by:

a small business
a publicly funded health care institution
any branch or agency of the Government of Canada or of a province or territory

Good manufacturing practices

This section is applicable after ISAD IO expires on September 16, 2021. Please refer to the Good manufacturing practices section of the ISAD IO guidance document.

For information on the requirements around good manufacturing practices (GMP), consult the:

Good manufacturing practices guide for drug products (GUI-0001)

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

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

If you're unable to obtain documents outlined in GUI-0080 due to the pandemic, please email us at foreign.site-etranger@hc-sc.gc.ca. You should contact us before you send in your DEL application. Be sure to include "COVID-19" in your subject line.

If you're unable to host a GMP drug inspection at your facility due to the pandemic, please email us at GMP_Questions_BPF@hc-sc.gc.ca. We may consider operational relief and flexibilities to inspection timelines as set under the current fee regime on a case-by-case basis. To monitor compliance, GMP inspections will be conducted using a risk-based approach for licensable activities.

Extension of certain flexible measures for DEL and GMP compliance, as communicated in DEL bulletins, will continue until further notice.

For more information about good manufacturing practices and COVID-19, see our page on good manufacturing practices and COVID-19.

Finished product testing

DEL holders must meet all product release requirements as outlined in the Food and Drug Regulations.

Finished product testing requirements in C.02.019 of the Regulations no longer apply to a distributor or importer of a schedule D (biologic) COVID-19 drug if it's subject to a written request under the lot release program (C.04.015).

Licence holders must comply with testing requirements set out in Division 2 of the Regulations. If you are unable to meet these requirements due to the pandemic, contact us at GMP_Questions_BPF@hc-sc.gc.ca.

For more information on the lot release program requirements, refer to the:

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Date modified:: 2022-12-16

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