Guidance on the Food and Drug Regulations for public health emergency drugs: Drug establishment licences, good manufacturing practices
On this page
- DELs for PHEDs
- Applying for a new or amended DEL for a PHED
- DEL terms and conditions
- DEL suspension and cancellation
- DEL performance standards
- DEL fees
- Good manufacturing practices
DELs for PHEDs
Division 1A of Part C of the regulations applies to a public health emergency drug (PHED). A person must hold a drug establishment licence (DEL) authorizing any activities conducted for a PHED.
Learn more:
- Guidance on drug establishment licences (GUI-0002)
- Management of applications and performance for drug establishment licences (GUI-0127)
If you have questions about the DEL requirements or DEL applications for PHEDs, email us at del.questions-leppp@hc-sc.gc.ca.
Include "public health emergency drug" in the subject line so that we can prioritize a response.
Applying for a new or amended DEL for a PHED
Sponsors can submit new DEL applications (C.01A.005(1) and (2)) or amendment applications (C.01A.006(1) and (1.1)) for a PHED 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 PHED, include:
- 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 PHED submitted under subsection C.01A.005(2) or C.01A.006(1.1) of the regulations
- the name of the drug
Email your completed application form to el.applications-le@hc-sc.gc.ca.
For more information on DEL requirements:
- 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.
PHED-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.
Learn more:
DEL terms and conditions
Health Canada may impose or amend terms and conditions on DELs for a PHED 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. This includes conditions under which drugs are fabricated, packaged, labelled or tested.
Learn more about the opportunity to be heard:
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).
Learn more:
DEL suspension and cancellation
To prevent a risk to health and safety in relation to a PHED, 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.
Learn more:
DEL performance standards
DEL applications for a PHED will be prioritized and reviewed based on the:
- public health need
- materials submitted in the application
- volume of information to be assessed
Learn more:
DEL fees
DEL fees apply to the review of DEL applications submitted in relation to a public health emergency drug. Consult the guidance document on:
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
Learn more:
- Guidance on evaluation fees for human drugs and disinfectants
- Small business mitigation for drugs and medical devices: Small business fee reduction measures
Good manufacturing practices
For information on the requirements around good manufacturing practices (GMP):
For evidence requirements to support GMP compliance of foreign buildings:
If you're unable to obtain documents outlined in GUI-0080 because of challenges directly associated with the public health emergency, email foreign.site-etranger@hc-sc.gc.ca.
You must contact us before you send in your DEL application and 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, email 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(2)).
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, email GMP_Questions_BPF@hc-sc.gc.ca.
Learn more:
Page details
- Date modified: