Health Canada takes action to quickly respond to potential drug shortages during COVID-19 pandemic

Drug Establishment Licensing Bulletin 82, April 6^th, 2020

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 IO can be found in the explanatory note.

Drugs that are eligible under the IO

Drugs included on the list of drugs for exceptional importation and sale are called "designated drugs". They are eligible for the exceptional importation and sale provisions provided for in the IO. The list is incorporated by reference in the IO. Health Canada maintains and updates it as required.

Criteria for adding a drug to the list

At this time, Health Canada will consider adding drugs that meet both of the following criteria 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.

Health Canada may consider other criteria for adding products to the list of designated drugs.

Visit the drug shortages website and sign up for daily notifications of drug shortages.

Tier 3 drug shortages

Tier 3 drug 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) includes federal and provincial/territorial governments, health care professionals and industry stakeholders. The committee 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 the Tier 3 drug shortages list may be added to the list of drugs for exceptional importation and sale.

How to propose an addition to the list of designated drugs

If you wish to propose an addition to the list of designated drugs, follow these steps:

Step 1: Submit proposal

To add a drug in a Tier 3 shortage to the list of drugs for exceptional importation and sale, you must submit a proposal to us.

Once we review the proposal, we may contact you to clarify information or to ask for product-specific information. Our review depends on a number of factors, including product type and availability of supply.

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

Step 2: Ensure compliance

We must have evidence that foreign buildings that fabricate, package/label and test designated drugs and their active pharmaceutical ingredients (API) follow good manufacturing practices (GMP). They must be GMP-compliant for the applicable activity, category of drugs and dosage form.

In many cases, we expect that 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
API annex

For these cases, there will be no need for additional foreign building compliance information, unless we have asked for it.

Foreign buildings that are not listed on the foreign building annex of the Canadian importer's DEL will be advised of the requirements related to compliance evidence and documentation.

A foreign building will be considered compliant if it's determined it's in compliance for the applicable activity, category of drugs and dosage form by:

Health Canada
a trusted regulatory partner

Other examples of foreign building compliance may be accepted on a case-by-case basis. We will speed up the approval process to amend the DEL.

How to import and sell designated drugs

If you wish to import and sell designated drugs, follow these steps:

Step 1: Approval to import and sell designated drugs

Canadian importers will be able 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

Canadian importers may sell designated drugs once they're included on the list of designated drugs. However, they must still notify us when they import designated drugs.

Step 2: Pre-importation notification requirements

Importers must notify us by email at least 5 calendar days before the day they import a designated drug. Make sure your email contains 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 IO, Canadian importers may bring designated drugs into the country without meeting all the requirements of the Food and Drug Regulations (FDR). However, importers:

are still obligated to report all adverse drug reactions (C.01.016 to C.01.019)
must report all recalls (C.01.051)
must adhere to all DEL requirements in Division 1A of the FDR, including listing foreign buildings on their licence
includes considerations applicable for the active pharmaceutical ingredient (API), intermediates and finished dosage forms
must fulfill most GMP requirements, as outlined in Division 2 of the FDR, with some exceptions (see the next section)

Also:

hospitals and 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 should note the exemptions to certain sections in Part A of the FDR, as indicated in the IO. They should also note 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)

IO 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 FDR at the importer's building address in Canada. Records include:

master production documents
validation reports
executed batch records
stability documentation

However, this information must be made available to us 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, including an inspection of the following elements:
- 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.

Biocides

For DIN applications and new drug submissions for eligible biocides under the IO, we do not require mock-ups of labels or package inserts. However, we do require the full text of labels and inserts. These are modifications of sections C.01.014(2)(m) and (m.1), C.08.002(2)(j) and (j.1) of the regulations under the IO.

No DEL is required to import or sell DIN hand sanitizers or hard-surface disinfectants.

However, you must email us to import and sell a biocide or natural health product hand sanitizer under the interim measure implemented on March 18, 2020. The subject line should read "Proposed Biocide for Exceptional Import and Sale".

Note: Importers are responsible for ensuring they meet all applicable GMP requirements. All importations and sales must also meet Division 2 requirements under the FDR.

Contact us

To add a drug to the list, submit proposals to hc.ds-iopropau-pm.sc@canada.ca.

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

To import biocides or natural health product hand sanitizer under the interim measure, contact hc.covid19healthproducts-produitsdesante.sc@canada.ca.

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Date modified:: 2022-08-22

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