Guidance on the Food and Drug Regulations for public health emergency drugs: Drug establishment licences, good manufacturing practices
On this page
- DELs for public health emergency drugs
- Applying for a new or amended DEL for a public health emergency drug
- DEL terms and conditions
- DEL suspension and cancellation
- DEL performance standards
- Drug establishment licence fees
- Good manufacturing practices
DELs for public health emergency drugs
Division 1A of Part C of the Food and Drug Regulations (regulations) applies to public health emergency drugs. A person must hold a drug establishment licence (DEL) authorizing any activities conducted for public health emergency 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 Management of applications and performance for drug establishment licences (GUI-0127)
If you have questions about the DEL requirements or DEL applications for public health emergency drugs, please email us at del.questions-leppp@hc-sc.gc.ca. Include the term "public health emergency drug" in your email subject line for a faster response.
Applying for a new or amended DEL for a public health emergency drug
New DEL applications (C.01A.005(1) and (2)) or amendment applications (C.01A.006(1) and (1.1)) for a public health emergency 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 public health emergency drug, be sure to include the following information:
- the subject line "public health emergency 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 public health emergency drug submitted under subsection 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:
- Drug establishment licences (GUI-0002)
- How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
- Management of applications and performance for drug establishment licences (GUI-0127)
Issuance of a DEL for a public health emergency drug
Health Canada issues or amends DELs in accordance with Part C, Division 1A of the regulations.
Public health emergency drug-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:
DEL terms and conditions
At any time, Health Canada may impose or amend terms and conditions on DELs for a public health emergency drug submitted under the regulations. Decisions to impose or amend terms and conditions are based on the need to mitigate, prevent, or manage risk to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled, or tested.
Any existing terms and conditions imposed on a DEL for a COVID-19 drug will continue to apply under the Regulations as necessary. The authority to impose and amend terms and conditions at any time on existing COVID-19 DELs will continue to apply.
DEL holders that do not comply with the terms and conditions imposed on their licence will be subject to compliance and enforcement action for contravening section 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
To prevent a risk to health and safety in relation to a public health emergency drug, 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. When a DEL is suspended or cancelled, the DEL holder must cease all suspended or cancelled activities.
For more information on DEL suspension and cancellation, consult the:
DEL performance standards
DEL applications for public health emergency 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:
Drug establishment licence fees
Drug establishment licence fees apply to the review of DEL applications submitted in relation to a public health emergency drug.
Please consult the guidance document on:
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
For information on the requirements around good manufacturing practices (GMP), consult the:
Evidence requirements to support GMP compliance of foreign buildings is included in the following guidance:
If you're unable to obtain documents outlined in GUI-0080 because of challenges directly associated with the public health emergency, 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 "public health emergency drug" in your subject line.
If you're unable to host a GMP drug inspection at your facility because of challenges directly associated with the public health emergency, 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.
Finished product testing
DEL holders must meet all product release requirements as outlined in the regulations.
Finished product testing requirements in section C.02.019 of the regulations do not apply to a distributor or importer of a Schedule D (biologic) COVID-19 drug if the lot of the drug is the subject of a request made under the lot release program (subsection C.04.007(1)).
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 applicable public health emergency, contact us at GMP_Questions_BPF@hc-sc.gc.ca.
For more information, refer to the:
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