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Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148)

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Organization: Health Canada

Published: 2022-03-02

Date of implementation:
2022-03-02

Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

Date approved: February 9, 2022
Date implemented: March 2, 2022

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Introduction

Health Canada is responsible for helping people in Canada maintain and improve their health. This is done, in part, by helping to ensure that people in Canada have access to the drugs they need when they need them and that these drugs meet an acceptable level of safety.

Sections C.01.014.8 and C.10.004 to C.10.011 of the Food and Drug Regulations (FDR) create a framework for the exceptional importation and sale of foreign-authorized drugs. This framework was created to help prevent and mitigate drug shortages.

Drugs imported under this framework are labelled for a foreign market, but have been manufactured according to quality standards similar to those required in Canada. These drugs do not receive a Canadian notice of compliance. They are only permitted to be imported for sale during a limited period of time.

Exceptional importation was initially implemented through the following interim orders:

The provisions for the exceptional importation framework from IO No. 2, with some modifications, were made permanent through amendments to the FDR. The entry into force of these provisions was March 2, 2022, the day after IO No. 2 ceased to have effect.

Transitional provisions are included in the regulatory amendments for regulated parties that have imported drugs in accordance with IO No. 2 and must now come into compliance with the regulatory framework.

For more information on drug shortages and the roles of various parties in addressing shortage situations, consult the Drug Shortages in Canada page.

Purpose and scope

Purpose

This guidance document is meant to help drug establishment licence (DEL) holders involved in the exceptional importation and sale of drugs understand how to comply with the regulations. This document is intended to help you understand sections C.01.014.8 and C.10.004 to C.10.011 of the FDR by outlining:

Scope

Inclusions

Sections C.01.014.8 and C.10.004 to C.10.011 of the FDR apply to the following drugs for human use that have a Canadian drug identification number (DIN):

Exclusions

Natural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of these provisions.

Understanding the regulations

Exceptional importation

Subject to sections C.01.014.8 and C.10.004 to C10.011 of the FDR, Health Canada may allow the exceptional importation and sale of a foreign-authorized drug by adding it to the List of Drugs for Exceptional Importation and Sale (the list). The list is incorporated by reference into the FDR and is updated as required. In order to have a foreign-authorized drug added to the list, the importer must hold an active DEL that meets the requirements laid out in the DEL information section.

Drugs on this list are known as designated drugs. They may be imported and sold to prevent or mitigate a drug shortage.

Examples of drugs that may be eligible for exceptional importation and sale (not an exhaustive list) include:

For a drug to be considered eligible for exceptional importation and sale in order to prevent or address a drug shortage, Health Canada has established the following criterion through policy:

Critical drug shortages are almost always national in scope and fall into one of 2 categories:

  1. Tier 3 drug shortages: The Protocol for the Notification and Communication of Drug Shortages sets out a tiered classification system for drug shortages. Tier 3 shortages are drug shortages that are expected to have the most significant impact on the Canadian drug supply and health care system. Impact is largely determined based on low availability of alternative supplies, ingredients or therapies. Tier 3 drug shortages are determined by a Tier Assignment Committee (TAC), which is an ad hoc committee of federal and provincial/territorial governments, health care professionals and industry stakeholders. Drugs assessed by the TAC to be in a Tier 3 shortage are posted online in the List of Tier 3 Drug Shortages. All Tier 3 shortages are considered to be critical drug shortages.
  2. Shortages with specific patient impacts: Other shortages not meeting the definition of a Tier 3 shortage may be considered to be critical if certain patient groups (for example, niche drugs that would affect a small number of patients) are likely to experience a serious impact.

Health Canada will consider proposals for adding a foreign-authorized drug to the List of Drugs for Exceptional Importation and Sale if the Canadian drug is considered to be in or at risk of a critical shortage.

The exceptional importation and sale framework is meant to complement other pathways that exist for accessing drugs under various special circumstances. Examples of such pathways are:

The following sections describe the process leading to the exceptional importation and sale and the importation and sale requirements.

Submitting a proposal and adding a drug to the List of Drugs for Exceptional Importation and Sale

Submitting a proposal

Regulatory requirements outlining when a drug may be added to the List of Drugs for Exceptional Importation and Sale are found in section C.10.005 of the FDR.

Health Canada has developed a process by which a DEL holder can submit a proposal to add a drug to the List of Drugs for Exceptional Importation and Sale. We will only consider proposals for foreign-authorized drugs that are considered appropriate substitutes for a drug in or at risk of a critical shortage.

Email the completed proposal form to drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.

The details provided in the proposal form allow Health Canada to assess the foreign-authorized drug under consideration to determine if there are reasonable grounds to believe:

This information, which will be reviewed on a case-by-case basis, includes:

Product-specific information:

DEL information:

To have a drug added to the List of Drugs for Exceptional Importation and Sale:

For more information on the DEL application process and requirements, consult the:

When amending a DEL Foreign Building Annex and API Foreign Building Annex, please consult the Guidance document on how to demonstrate foreign building compliance with drug GMP (GUI-0080) for more information.

To address a critical drug shortage, Health Canada may expedite the process to issue or amend a DEL in order to facilitate exceptional importation.

Health Canada will follow up with the DEL holder if any additional information is needed to evaluate a proposal. We will communicate the results of the evaluation of the proposal to the DEL holder. In the case where a decision is made to not add the foreign-authorized drug to the List of Drugs for Exceptional Importation and Sale, the DEL holder will be made aware of the reason(s) for the refusal. The DEL holder may address the issues for the initial refusal through the submission of a new proposal form.

Adding a drug to the List of Drugs for Exceptional Importation and Sale

Regulatory requirements for adding a drug to the List of Drugs for Exceptional Importation and Sale are found in section C.10.005 of the FDR. Further requirements related to the information required for the list are found in section C.10.006 of the FDR.

Once a proposal is accepted, Health Canada will notify the DEL holder in an email and place the designated drug on the List of Drugs for Exceptional Importation and Sale. Designated drugs may be imported once they have been added to this list and the DEL holder has met the notification requirements as outlined in the regulations.

Once imported, drugs may be sold until their expiry date, even if further importation is no longer permitted. Guidance on meeting other regulatory requirements before importing and/or selling these drugs is found in the following sections.

Designated drugs do not receive full market authorization in Canada and are not assigned a DIN (FDR, section C.10.008(1)(b)).

The following information is posted publicly on the List of Drugs for Exceptional Importation and Sale:

Health Canada may modify limitations on dates and importation quantities to address the changing circumstances of a shortage. We will notify DEL holders in advance of any changes.

Companies are encouraged to evaluate the quantities required to support the Canadian market before engaging in the exceptional importation of a drug so that an excess of product is not imported. Health Canada is not responsible for designated drugs that remain unsold in Canada.

Health Canada will remove a drug from the List of Drugs for Exceptional Importation and Sale if it is determined that incorrect or misleading information was provided in the proposal or any associated requests for information. We may also remove a drug from the list based on a risk assessment, which may result in a stop sale, recall or other post-market actions. We will notify affected DEL holders as early as possible.

The List of Drugs for Exceptional Importation and Sale indicates the most recent date that the list was updated. Health Canada will work with and/or notify the affected DEL holder(s) when a change is being made. All other DEL holders may consult the list regularly to monitor the status of the various drugs on the list.

Notification requirements before importing and selling a designated drug

Regulatory provisions for notification requirements are found in section C.10.006 (1)(a) of the FDR.

DEL holders must notify Health Canada at least 3 business days before they import a designated drug. This is necessary to help avoid unnecessary processing delays at the border.

Please email your notification to drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca. Include the following information in the notification:

DEL holders must communicate any changes to this information between the initial notification and importation dates. Changes must be communicated using drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.

Health Canada advises DEL holders to include the customs identification number in the notification. If a DEL holder does not know the customs identification number at the time of import notification, this should not delay the submission of the import notification. You should clearly indicate if this is the case and that you will provide the number when it is available. Email us at drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.

Information to support the safe use of the drug

Regulatory provisions for the detailed description of conditions of use of the drug are found in section C.10.011 of the FDR.

DEL holders can import a drug once it has been added to the List of Drugs for Exceptional Importation and Sale. However, the drug product cannot be sold until information is available on the conditions to support the safe use of the drug. Health Canada refers to this information as the risk communication.

Health Canada will discuss the requirements for the risk communication plan with DEL holders during the proposal review process. In most cases, companies are expected to generate letters to health care professionals informing them about the safe use of the designated drug. The letters should also contain information comparing the Canadian-authorized product to the foreign-authorized product.

Before a designated drug can be sold in Canada, risk communications to support its safe use must be finalized and available in both English and French.

A company's risk communication plan should include the following information:

For additional information about risk communication requirements, refer to the risk communication plans page.

Good manufacturing practice (GMP) requirements for selling designated drugs

Regulatory GMP requirements for selling designated drugs are found in sections C.10.008(1)(b), C.10.009 and C.10.010 of the FDR. Designated drugs must meet all GMP requirements in the FDR (Part C, Division 2 on good manufacturing practices) with the exception of the following:

Finished product testing requirements:

The requirements in section C.02.019 of the FDR have been modified for designated drugs to:

Record-keeping requirements:

The records specified in section C.02.020 (1) paragraphs a, b and d of the FDR are required to be maintained but need not be maintained on the DEL holder's premises in Canada. However, this information must be provided electronically in a format specified by or acceptable to Health Canada when requested by Health Canada.

These records include:

Other regulatory requirements and exemptions under the exceptional importation framework

Other regulatory requirements and exemptions under the exceptional importation framework are found in sections C.10.007 to C.10.009 of the FDR.

Designated drugs are exempt from the following FDR provisions:

DEL holders should note the requirements that remain in effect, including:

Note: All other applicable FDR provisions remain in effect. Examples include the following:

  • 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)

Removing drugs from the List of Drugs for Exceptional Importation and Sale

Critical drug shortages are considered resolved when the Canadian-authorized drug is available in sufficient quantities to meet demand. For Tier 3 shortages, decisions to remove a drug from the List of Tier 3 Drug Shortages are made by the TAC, including the same representatives who determined that the drug was in a Tier 3 shortage.

Once a critical drug shortage is resolved, Health Canada may amend:

This is done so that no further inventory is imported. However, the drug will remain on this list for a time to allow the remaining inventory in Canada to be sold until its expiry date.

Once a shortage has been resolved, Health Canada will remove the following from the list:

Health Canada will notify DEL holders when the process to remove a designated drug from the List of Drugs for Exceptional Importation and Sale has begun. We may ask for information from the DEL holder to help determine when the drug should be removed from the list.

A drug that has been removed from the List of Drugs for Exceptional Importation and Sale can no longer be imported or sold.

Coming into force and transition from interim order provisions

Coming into force of the Regulations

The amendments to the FDR come into force on March 2, 2022.

Transitional provisions

On March 2, 2022, all active products that were added to the List of Drugs for Exceptional Importation and Sale under IO No. 2, and whose Canadian substitute is still in or at risk of a critical shortage, will be transitioned to the new list and covered under the new regulations. Transitional provisions are outlined in sections 10 to 15 in the amendments to the FDR.

These drugs will be subject to the FDR requirements and guidance stipulated in this document.

Health Canada will work with DEL holders for existing products on the List of Drugs for Exceptional Importation and Sale to assign an end of importation date and, if applicable, maximum quantities for importation and sale. This information will be added to the list.

Contact us

For more information about drug shortages in Canada, please visit our drug shortages page.

For questions about drug shortage and discontinuation regulations, email us at Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca.

For questions about submitting a proposal or adding a drug to the List of Drugs for Exceptional Importation and Sale, email us at drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.

At least 3 days before importing designated drugs, submit notifications to drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.

For questions on the DEL application requirements, email us at del.questions-leppp@hc-sc.gc.ca.

For questions on the Domestic GMP requirements, email us at drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.

For questions on the Foreign GMP requirements, email us at foreign.site-etranger@hc-sc.gc.ca.

Definitions

Actual shortage: a manufacturer's current supply cannot meet current demand in Canada (pénurie réelle) (refer to "Shortage")

Anticipated shortage: a manufacturer's future supply cannot meet projected demand in Canada (pénurie anticipée) (refer to "Shortage")

Business day: a day other than a:

(jour ouvrable) (FDR, C10.006 (2))

Critical drug shortages: shortages that will have the most impact on the health of people in Canada

Critical drug shortages are almost always national in scope and fall into 2 classes:

  1. Tier 3 drug shortages: The Protocol for the Notification and Communication of Drug Shortages sets out a tiered classification system for drug shortages:
    • Tier 1: anticipated shortages, of which a manufacturer or importer expects that future supply may not meet projected demand for the drug
    • Tier 2: actual drug shortages
    • Tier 3: actual drug shortages with the greatest potential impact on the Canadian drug supply and health care systems by virtue of availability of alternative supplies, ingredients or therapies

      Tier 3 shortages are determined on a case-by-case basis by a specially convened Tier Assignment Committee (TAC), which includes representatives from federal and provincial/territorial governments and health care professionals. Drugs assessed by TAC to be in Tier 3 shortage are posted online in the List of Tier 3 Drug Shortages. All Tier 3 shortages are considered critical drug shortages.

  2. Shortages with specific patient impacts: Other shortages may also be considered to be critical even if they do not meet the definition of a Tier 3 shortage if it is determined that such shortages will impact the health of specific groups of patients. For example, a shortage of a niche drug that would impact a small number of patients would be considered to be critical without necessarily meeting the definition of a Tier 3 shortage.

    Shortages with specific patient impacts are determined by Health Canada. Health Canada looks at the on-label use of the drug to determine if it would impact the health of people in Canada if not available to those who need it.

Designated drugs: a drug that is set out in the List of Drugs for Exceptional Importation and Sale (drogue désignée) (FDR, C10.004 (1))

Drug: any of the following drugs for human use:

  1. drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act
  2. prescription drugs
  3. drugs that are listed in Schedule C or D to the Act and
  4. drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner

(drogue) (FDR, C.10.004 (1))

For clarity:

Drug establishment licence (DEL): a licence issued to a person in Canada pursuant to Division 1A of the FDR to conduct licensable activities in a building that has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations (Licence d'établissement de produits pharmaceutiques (LEPP))

Drug identification number (DIN): an 8-digit numerical code assigned by Health Canada to each drug product marketed under the Food and Drugs Act and Regulations

A DIN uniquely identifies the following product characteristics: manufacturer, product name, medicinal ingredient(s), strength of medicinal ingredients(s), pharmaceutical form, route of administration (numéro d'identification d'un médicament)

Establishment licence: refer to drug establishment licence above

Expiration date: in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month:

(date limite d'utilisation) (C.01.001 (1))

Fabricate: to prepare and preserve a drug for the purposes of sale (manufacturer) (FDR, C.01A.001(1))

Foreign regulatory authority: a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction (autorité réglementaire étrangère) (FDR, C10.001(1) and C10.004(1))

Incorporation by reference: a term used to describe a mechanism, which allows a document or list that is not in the text of the regulations, in whole or in part, to be made a part of the regulations. Health Canada uses incorporation by reference to achieve policy and regulatory objectives.

Incorporation by reference enables Health Canada to leverage existing documents and maintain agile regulatory frameworks that can more quickly adapt to changes in science or technology, or in response to an emerging health or safety risk. Incorporation by reference can also contribute to items such as regulatory alignment with the provinces and territories and to international cooperation on matters of trade, without compromising health and safety (incorporation par renvoi) (Health Canada Incorporation by Reference Policy)

List of drugs for exceptional importation and sale: published and updated by the Government of Canada on its website (FDR, C10.004 (1)). A drug included on this list is permitted to be imported and sold for the duration and in the quantities specified (if applicable). This list is incorporated by reference in the FDR. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)

Manufacturer: a person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them, sells a food or drug (fabricant) (FDR, A.01.010)

Market authorization holder (MAH): the legal entity that holds the notice of compliance, the Drug Identification Number (DIN), the medical device licence, the product licence or that has received authorization to import and sell a drug for the purpose of a clinical trial (détenteurs d'une autorisation de mise sur le marché (DAMM))

MRA country: a country that is a participant in a mutual recognition agreement with Canada (pays participant) (FDR, C.01A.001(1))

For clarity, this term can also be taken to mean jurisdictions other than countries (for example, the European Union), with which Canada has an MRA

Package/label: to put a drug in its immediate container or to affix the inner or outer label to the drug (emballer-étiqueter) (FDR, C.01A.001(1))

Person: an individual or an organization as defined in section 2 of the Criminal Code (personne) (FDA, section 2)

Shortage: in respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the Drug Identification Number assigned for the drug is unable to meet the demand for the drug in Canada (pénurie) (FDR, C.01.014.8 (2))

Tier 3 drug shortage: refer to critical drug shortages above (les pénuries de niveau 3)

Tier 3 list: a list published online and maintained by Health Canada that lists the molecules/drugs whose finished dosage form(s) are in shortage on the Canadian market. The molecules/drugs have been determined to meet the definition of a Tier 3 shortage by a Tier Assignment Committee (Liste des pénuries de niveau 3)

Tier Assignment Committee (TAC): an ad hoc committee of federal and provincial/territorial governments, health care professionals and industry stakeholders that makes recommendations on the tier assignment of a drug shortage (Comité d'attribution de niveaux (CAN))

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