There is an unprecedented demand and urgent need for access to drugs during the COVID-19 pandemic. On March 30, 2020, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. The interim order (IO) allows certain drugs that may not fully meet regulatory requirements to be imported and sold in Canada.
An IO is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory processes. Further information on this Interim Order can be found in the Explanatory Note.
Drugs that are eligible under the interim order
Drugs included on the List of Drugs for Exceptional Importation and Sale are called “designated drugs” and are eligible for the exceptional importation and sale provisions provided for in the Interim Order. The list, which will be updated as required, is incorporated by reference in the IO and is maintained by Health Canada.
Criteria for adding a drug to the List of Drugs for Exceptional Importation and Sale
At this time, drugs that meet both of the following criteria will be considered for addition to the list of designated drugs:
- Significant shortage: Only drugs in shortage designated as a Tier 3 shortage are eligible, as defined by the Multi-Stakeholder Steering Committee Protocol on Notification of Drug Shortages.
- Good manufacturing practices compliance: Drugs must be manufactured in accordance with GMP requirements. Companies that are importing and selling the designated drugs must have a Drug Establishment Licence (DEL):
- The DEL must cover the importation of the drug under the applicable category and dosage form.
- Buildings outside Canada must be listed in the Foreign Annex of the importer’s DEL for the applicable activity, category of drugs and dosage.
NOTE: Other criteria may also be considered by Health Canada in adding products to the list of designated drugs.
Visit the drug shortages website and sign up for daily notifications of drug shortages.
Tier 3 shortages are those that have the greatest potential impact on Canada’s drug supply and health care system. Impact is based on low availability of alternative supplies, ingredients or therapies.
The Tier Assignment Committee (TAC), which includes federal and provincial/territorial governments, healthcare professionals, and industry stakeholders, makes recommendations on the tier assignment of drug shortages. The TAC assessment includes:
- a review of the information gathered on the shortage issue, and
- a thorough discussion on its potential impact and next steps.
Note: At this time, only drugs on this list are eligible to be added to the List of Drugs for Exceptional Importation and Sale.
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 attached 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. HC review depends on a number of factors, including but not limited to product type and availability of supply.
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), and
- the API annex.
For these cases, there will be no need for additional foreign building compliance information, unless requested by Health Canada.
In cases where the foreign buildings are not currently listed on the Foreign Building Annexe of the Canadian importer’s DEL, Health Canada will clearly communicate foreign building compliance evidence and documentation requirements.
A foreign building will be considered compliant if:
- It is currently determined to be compliant by Health Canada
- It is currently determined to be compliant by a trusted regulatory partner for the applicable activity, category of drugs and dosage form.
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 Drugs for Exceptional Importation and Sale
- 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
Regulatory requirements for selling designated drugs
During the application of the interim order, Canadian importers may bring designated drugs into the country without meeting all the requirements of the Food and Drug Regulations (FDR). 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 FDR, including listing foreign buildings on their licence (this 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 FDR, with some exceptions (see the next section).
Importers should note the exemptions to certain sections in Part A of the FDR, 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 interim order (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 prior to release of product.
- Confirmation that the drug has been transported and stored properly.
- Visual inspection of the drug to confirm its identity. Visual inspection should include:
- product labelling
- dosage form
- physical measurements (for example, dimensions, volume), if applicable
Release documentation should clearly indicate that the drug was released under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19.
HC Disinfectant Sanitizing Form_EN(v2-2)
HC Disinfectant Sanitizing Form_ FR(v2-2)
HC Form ProposalExceptionalImport DRUGS v3 EN
HC Form ProposalExceptionalImport DRUGS v3 FR
