Exceptional importation and sale of drugs in relation to COVID-19: For industry

How to propose an addition to the list of designated drugs

The following actions must be taken to propose an addition to the list of designated drugs.

Step 1: Submit proposal

To add a drug in a Tier 3 shortage to the List of Drugs for Exceptional Importation and Sale, please fill out the proposal form and email it to hc.ds-iopropau-pm.sc@canada.ca.

Health Canada will assess the proposal and may contact you to clarify information or to ask for product-specific information. Our review depends on a number of factors, including but not limited to product type and availability of supply.

Of note, Canadian importers need to provide a risk communications plan in their proposal outlining how they will ensure accessibility of information that supports safe use of the drug. Importers are required to make the information available in both official languages.

Note: We may also add a product to the list without receiving a proposal.

Step 2: Ensure compliance

Health Canada must have evidence that foreign buildings which fabricate, package/label and test designated drugs and their active pharmaceutical ingredients (API) are GMP compliant for the applicable activity, category of drugs and dosage form.

Health Canada expects that, in many cases, designated drugs will be sourced from foreign buildings that are already listed on the:

Foreign Building Annex of the Canadian importer’s DEL (with the applicable activity, category of drugs and dosage form)
API annex

For these cases, there will be no need for additional foreign building compliance information, unless requested by Health Canada.

If the foreign buildings are not currently listed on the Foreign Building Annex of the Canadian importer’s DEL, Health Canada will clearly communicate foreign building compliance evidence and documentation requirements.

A foreign building will be considered GMP-compliant if it’s currently determined to be compliant for the applicable activity, category of drugs and dosage form by Health Canada or a trusted regulatory partner.

Other examples of foreign building compliance may be accepted on a case-by-case basis. Health Canada will expedite the approval process to amend the DEL.

How to import and sell designated drugs

Step 1: Approval to import and sell designated drugs

Canadian importers will be permitted to import and sell designated drugs once:

the drug is on the List of Designated Drugs for Exceptional Importation and Sale (link at the top of this page)
their DEL Foreign Building Annex and API building annex have been amended as required

Although the Canadian importer is permitted to sell designated drugs once included on the list of designated drugs, they must still notify Health Canada when designated drugs are imported.

Step 2: Pre-importation notification requirements

Importers must notify Health Canada at least 5 calendar days before the day they import a designated drug. They must do so by sending an email to hc.ds-ionotifau-pm.sc@canada.ca. The email must contain the following information:

importer’s name and contact information
name, address and contact information of each fabricator, packager/labeller and tester involved with the drug
brand name of the drug to be imported
medicinal ingredient(s)
dosage form
strength
route of administration
identifying code
detailed description of the conditions of use of the drug
intended port of entry into Canada
intended date of arrival into Canada
customs identification number for the shipment
total quantity of drug to be imported

Step 3: Information to support safe use requirements

Under section 9 of the Interim Order (IO), Canadian importers are required to ensure information is available in both official languages and in a manner that supports safe use of the drug. Canadian importers are expected to work closely with Health Canada on the review and implementation of a risk communications plan to ensure compliance with this requirement.

Regulatory requirements for importing and selling designated drugs

During the application of the IO, Canadian importers may bring designated drugs into the country and sell them without meeting all the requirements of the Food and Drug Regulations. However, Health Canada wishes to highlight the following:

Importers are still obligated to report all adverse drug reactions (C.01.016 to C.01.019).
Hospitals/Medical Professionals must continue to report serious adverse drug reactions (C.01.020.1).
Existing requirements and controls for prescription drugs will remain in effect (C.01.040.3 to C.01.049).
Importers must report all recalls (C.01.051).
Importers must adhere to all DEL requirements in Division 1A of the Regulations, including listing foreign buildings on their licence (includes considerations applicable for the active pharmaceutical ingredient (API), intermediates and finished dosage forms).
Importers must fulfill most good manufacturing practices (GMP) requirements, as outlined in Division 2 of the Regulations, with some exceptions (see the next section).

Importers should note the exemptions to certain sections in Part A of the Regulations, as indicated in the interim order, along with the requirements that remain in effect, including:

obligations for security packaging when the drug is intended for sale to the general public (A.01.065)
provisions relating to advertising (A.01.067) and sale (A.01.068)

Interim Order changes to GMP requirements for Canadian importers

Canadian importers of designated drugs must follow the same GMP requirements that apply to all imported drugs. The IO provides some exceptions.

Keeping records

Importers do not need to maintain records specified in Section C.02.020 (1) parts a, b and d of the Food and Drug Regulations at the importer’s building address in Canada, such as:

master production documents
validation reports
executed batch records
stability documentation

However, this information must be made available to Health Canada upon request.

Written agreements

Canadian importers should ensure they have access to written agreements when importing designated drugs.

Release process

Canadian importers can base the release of a designated drug on:

Certificates of Analysis and Certificates of Manufacture (or equivalent) from buildings listed on the DEL Foreign Building Annex
- all release testing must be completed before the product is released
confirmation that the drug has been transported and stored properly
visual inspection of the drug to confirm its identity, involving an inspection of the:
- product labelling
- dosage form
- physical measurements (for example, dimensions, volume), if applicable

Release documentation should clearly indicate that the drug was released under Interim Order No.2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19.

Designated hand sanitizers

IO No. 2 reflects changes to the requirements for hand sanitizers outlined in IO No.1.

Incoming submissions for designated hand sanitizers must include all application content requirements in the Food and Drug Regulations, including a label mock-up. A Drug Establishment Licence (DEL) is required to conduct licensable activities for designated hand sanitizers (fabricate, package/label, test, import or distribute).

Designated hand sanitizers refer to hand sanitizers that are classified as non-prescription drugs based on their active ingredients. For information on importing and selling natural health product hand sanitizers, please consult the guidance document on site licensing and guide on the licensing approach for the production and distribution of alcohol-based hand sanitizers.

Product authorization

If your product was approved under the IO without a label mock-up, you should submit the mock-up labels for review. You may submit a label mock-up at no charge under the Post-Authorization Division 1 Change (PDC) application pathway. Labels must comply with plain language labelling requirements.

For more information, please consult the following guidance documents:

If your product submission is pending a decision at the time that IO No. 2 takes effect, we will consider the submission using the terms of the original Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.

Drug Establishment Licences (DEL)

A DEL is required to conduct licensable activities (fabricate, package/label, test, import or distribute).

Industry has 6 months to adjust to the changes.

DEL transition period (March 1 to September 1, 2021)

If you conducted licensable activities for a designated hand sanitizer without holding a DEL under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, you may continue to conduct these activities for 6 months after IO No. 2 comes into effect. This takes you to September 1, 2021.

If you apply for a DEL (or apply to amend your DEL) during the 6-month transition period, you may continue to conduct the activities for the specific designated hand sanitizer(s) while Health Canada reviews your application.

If a DEL application is not received by September 1, 2021, you will be required to cease the licensable activities at the end of the transition period.

Note: Importers and sellers of designated hand sanitizers are still responsible for ensuring they meet all applicable GMP requirements under the Regulations throughout the transition period.

Applying for a DEL during the transition period

When submitting a DEL application to continue conducting licensable activities related to a designated hand sanitizer, please consult the following guidance documents:

Include the following information in your application:

written confirmation in the body of the application email or cover letter that the DEL application is related to activities conducted while the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was in effect
name of the specific hand sanitizer product(s) for which licensable activities were conducted

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

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

If you’re unable to obtain documents outlined in GUI-0080, you should email us at hc.foreign.site-etranger.sc@canada.ca before submitting your DEL application. Be sure to include "COVID-19" in the email subject line. Health Canada may consider other evidence on a case-by-case basis.

Note: New DEL applicants must be ready for an inspection at the time they submit an application. This is set out in our Good manufacturing practices inspection policy for drug establishments (POL-0011).

Contact us

To add a drug to the List of Designated Drugs, submit proposals to hc.ds-iopropau-pm.sc@canada.ca.

To import designated drugs, submit notifications to hc.ds-ionotifau-pm.sc@canada.ca.

For questions on the DEL transition period or application requirements, please contact us by email at hc.del.questions-leppp.sc@canada.ca.

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Date modified:: 2021-03-01

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