Information and application requirements for drugs authorized under the Interim Order: Guidance document

This guidance document supports the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. It provides guidance to applicants seeking to have a COVID-19 drug authorized. It also sets out the conditions to be met after an authorization is granted under this interim order.

Date published: 2020-09-17

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Introduction

Scope and application

This guidance document applies to the following COVID-19 drugs:

This guidance document does not apply to:

For guidance with respect to applications for the import or sale of non-prescription pharmaceuticals available over-the-counter, disinfectants, hand sanitizers and veterinary health products, sponsors should refer to:

The Interim Order provides the Minister with the authority to permit the sale of a COVID-19 drug in Canada via three mechanisms.

  1. authorizing a new COVID-19 indication for a new drug, or for one that holds an existing authorization or notice of compliance with a modified set of application requirements with the potential for a “rolling” submission of information
  2. expanding an indication of a drug that is already licensed in Canada under the Food and Drug Regulations (Regulations), to include a COVID-19 indication based on known evidence and
  3. authorizing a drug based on certain elements being authorized by a foreign regulatory authority

The first mechanism is initiated by an application to Health Canada; the second mechanism is initiated by Health Canada (no application required); and the third mechanism is initiated by an application to Health Canada once Health Canada has added the drug to the List of Foreign Drugs.

Policy objectives

The guidance document is intended to provide assistance to applicants in preparing the documentation necessary to obtain an authorization for the importation or sale of a COVID-19 drug under the Interim Order, and to enable them to meet the post-market information and regulatory requirements.

Policy statements

Health Canada is committed to helping Canadians protect and improve their health by facilitating access to COVID-19 drugs that are safe, effective and of high quality as they become available. The Interim Order introduces new regulatory mechanisms to expedite the authorization of COVID-19 drugs during a public health emergency, while still upholding the requirements necessary for the health and safety of Canadians.

Applicants can choose the appropriate regulatory pathway for market authorization: filing a submission and obtaining a notice of compliance under Division 8 of the Regulations or filing an application and obtaining an authorization under the Interim Order. Applicants choosing to file under Division 8 of the Regulations should refer to the relevant guidance documents and fees applicable to that pathway.

Applicants are encouraged to consult with Health Canada as early as possible in the drug development process and on an ongoing basis. Health Canada is committed to prioritizing the review of any application for authorization for a COVID-19 drug under the Interim Order.

The Interim Order describes the requirements to obtain authorization to import or sell COVID-19 drugs in Canada. Applicants are responsible for filing an application and providing the necessary evidence to Health Canada. To facilitate use of this new pathway, existing guidance is referenced and the process for submitting applications, amending and providing additional information is maintained. The Interim Order allows for the earlier filing of applications for drugs that show promise to treat or prevent COVID-19. Applications for generics or biosimilars would not normally be considered under the Interim Order unless the authorized innovative drug is not available on the Canadian market, or only available in quantities that are inadequate to address the urgent public health need related to COVID-19.

Authorizations under this Interim Order will be granted only if Health Canada determines that the benefits and risks of the product are supported by evidence that the drug is safe, effective and of high quality. This takes into consideration the uncertainties related to the drug in the context of an urgent public health need related to COVID-19. A drug authorized under the Interim Order cannot be used as the Canadian Reference Product to obtain a notice of compliance for an Abbreviated New Drug Submission under section C.08.002.1 of the Regulations or as a comparator for a biosimilar drug under Division 8, Part C of the Regulations.

The Interim Order, once approved by the Governor-in-Council, is valid for a one-year term from the day it is signed by the Minister. Therefore, an authorization for importation and sale issued under this Interim Order is only valid for as long as the Interim Order is in effect. Authorizations issued are valid until expiry of the Interim Order. Health Canada is considering various options to minimize disruptions for the ongoing authorization of drugs upon the expiry of the Interim Order with the intent to implement transition measures to ensure products maintain their legal status as needed.

As with all drugs, Health Canada will assess and monitor the safety and effectiveness of all products authorized under the Interim Order. Health Canada will take immediate action, including the suspension or cancellation of authorizations or establishment licences, if required, to protect the health and safety of Canadians.

Background

COVID-19 is the infectious disease caused by the most recently discovered coronavirus, SARS-CoV-2. This new virus and disease were unknown before the outbreak began in December 2019 and have since spread around the world. COVID-19 has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory distress, kidney failure and death. Older people and those with underlying medical problems, such as high blood pressure, heart problems or diabetes, are more likely to develop serious illness.

COVID-19 is a new disease not previously identified in humans. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection. In the absence of therapies or vaccines to effectively treat or prevent COVID- 19, there is an urgent need to get novel therapies into clinical trials to gather information to support the safety and efficacy of the product and to support a market authorization.

Subsection 30.1(1) of the Food and Drugs Act allows the Minister to make interim orders, if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. To facilitate earlier access to drug products for COVID-19, Health Canada developed the Interim Order. The Interim Order allows the Minister to account for the urgent public health needs relating to COVID-19 in deciding whether to authorize a COVID-19 drug based on the provided evidence of safety, efficacy, and quality. If satisfied, it allows for the issuance of an authorization for the importation or sale of COVID-19 drugs.

Although COVID-19 is understood to be primarily a human disease and the SARS-CoV-2 virus is thought to spread mainly from person-to-person, COVID-19 is a new disease and its impacts on animal health may not be fully known at this time. Studies are underway to better understand how COVID-19 affects different animal species and the infection dynamics. Data is being generated swiftly. It is therefore important for Health Canada to be able to issue expedited authorization for the import or sale of veterinary drugs should a need for them arise as a result of COVID-19.

Definitions

Unless explicitly listed below, or in the Interim Order, all expressions in the Interim Order have the same meaning as under the Food and Drugs Act and Part A and Part C of the Food and Drug Regulations.

Authorization is defined in the Interim Order as means an authorization issued under section 5 of the Interim Order. (autorisation)

Chief Public Health Officer is defined in the Interim Order as the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act. (administratrice en chef de la santé publique)

COVID-19 is defined in the Interim Order as the coronavirus disease 2019. (COVID-19)

COVID-19 drug is defined in the Interim Order as a drug that is manufactured, sold or represented for use in relation to COVID-19. (drogue utilisée en lien avec la COVID-19)

Drug, according to the Food and Drugs Act, includes any substance or mixture of substances manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
  2. restoring, correcting or modifying organic functions in human beings or animals; or
  3. disinfection in premises in which food is manufactured, prepared or kept.

For the purpose of this guidance document, drug does not include: non-prescription pharmaceuticals available over-the-counter; disinfectants and hand sanitizers (antiseptic skin cleanser); veterinary health products; natural health products as defined in subsection 1(1) of the Natural Health Products Regulations. Drug does include: both prescription and non-prescription professional use pharmaceuticals; radiopharmaceuticals; biologically-derived products such as vaccines, blood derived products, and products produced through biotechnology; and veterinary drugs. (drogue)

Foreign drug means a drug that is described on the List of Foreign Drugs. (drogue étrangère)

Foreign regulatory authority is 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 and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)

List of applications received means the document entitled List of Applications Received by Health Canada for Drugs for Use in Relation to the COVID-19 Pandemic, as amended from time to time, that is published on a Government of Canada website. This is not a requirement under the Interim Order. (Liste des demandes reçues)

List of authorized drugs means the document entitled List of Drugs Authorized by Health Canada for Use in Relation to the COVID-19 Pandemic, as amended from time to time, that is published on a Government of Canada website. This is not a requirement under the Interim Order. (Liste des dogues autorisées)

List of foreign drugs means the document entitled List of Foreign Drugs in Relation to the COVID-19 Pandemic, as amended from time to time, that is published on a Government of Canada website. (Liste des drogues étrangères)

List of new drugs for expanded indication means the document entitled List of New Drugs for Expanded Indication in Relation to the COVID-19 Pandemic, as amended from time to time, that is published on a Government of Canada website.

Regulations means the Food and Drug Regulations.

Submission means any of the following:

  1. a new drug submission that is filed under section C.08.002 of the Regulations;
  2. an extraordinary use new drug submission that is filed under section C.08.002.01 of the Regulations;
  3. an abbreviated new drug submission that is filed under section C.08.002.1 of the Regulations; or
  4. an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1 of the Regulations. (présentation)

Supplement means a supplement to a submission that is filed under section C.08.003 of the Regulations. (supplément)

Guidance for implementation

Regulatory exemptions

The Interim Order provides COVID-19 drug applicants an exemption from the Regulations with the exception of certain requirements in Part A and Divisions 1, 1A, 2, 3, and 4 of Part C. Unless otherwise specified however, words and meanings have the meanings assigned to them by the Regulations.

Pre-submission meetings

Applicants wishing to submit an application under section 3 or subsection 4(2) of the Interim Order to Health Canada are strongly encouraged to request a pre-submission meeting to discuss all aspects of their application. Applicants should also come prepared to discuss their Application Plan, if applicable (refer to the Rolling applications section of this guidance document for more information on Application Plans).

Applicants are encouraged to hold early and ongoing consultation with Health Canada to help ensure that regulatory requirements are met.

Applicants should refer to the Management of Drug Submissions and Applications or the Management of Regulatory Submissions for veterinary drugs for instructions on how to request pre-submission meetings.

Applicants should forward their pre-submission meeting requests to the appropriate Directorate (Office) located within Health Canada. Please refer to Appendix A for relevant contact information.

Fees related to an application for a COVID-19 drug

Fees for regulatory activities related to human and veterinary drugs are normally charged as per the Fees in Respect of Drugs and Medical Devices Order. However, applications for authorization for a COVID-19 drug submitted under the Interim Order are not subject to these fees. Accordingly, applications are not subject to cost recovery fees for the review of an application, and authorization holders are not subject to fees for the right to sell COVID-19 drugs.

The Establishment Licence Fees Remission Order - Indication of an Activity in respect of a COVID-19 Drug (Remission Order) allows for the remission of fees associated with Drug Establishment License (DEL) applications submitted under the Interim Order. Fees will be remitted for the review of applications for a new DEL, applications to amend an existing DEL or applications for the Annual Licence Review of DELs submitted under the Interim Order. Applicants can refer to the section “DEL Fee Remission” of this guidance document for more information.

Submitting an application for a COVID-19 drug

Applications for authorization of a drug that meets the definition of a COVID-19 drug as defined in the Interim Order must clearly indicate its direct use in relation to the SARS-CoV-2 virus, including the active role the drug plays in the diagnosis, treatment, mitigation or prevention of COVID-19.

To be approved, an application for authorization of a COVID-19 drug must contain sufficient information and material for the Minister to render a decision whether or not to issue an authorization, on the basis of the issuance criteria in section 5 of the Interim Order. This information is highlighted in subsection 3(1) of the Interim Order. The Minister, under section 13 of the Interim Order, may also request any additional information or materials required to render a decision whether to grant an authorization under this Interim Order.

When an application has been received by Health Canada for a COVID-19 drug, it will be added to the List of Applications Received by Health Canada for Drugs for Use in Relation to the COVID-19 Pandemic, published by the Government of Canada on its website. The list includes applications submitted under sections 3 and 4 of the Interim Order.

Application for new COVID-19 drugs

Clarification on the specifics of the information required in an application for authorization for a new COVID-19 drug filed in accordance with the Interim Order is provided below.

Rolling applications

In subsection 3(2) of the Interim Order, it is recognized that applications may not be complete at the time of initial filing. Health Canada will begin its assessment using the information submitted by the applicant and accept new evidence as it becomes available until the application is deemed complete. This process can reduce time to authorization for these important new drugs while maintaining appropriate standards of safety, efficacy, and quality.

In the case where information or material referred to in any of paragraphs (1) (g) to (k) or (m) to (o) of the Interim Order is omitted from the application or is incomplete (for example, interim reports instead of final reports from a clinical study, manufacturing process validation started but not completed, etc.), the applicant must include an Application Plan at the time of initial filing of an application. The plan should describe the studies to be completed and the timing of when it is planned for submission to Health Canada. It should contain:

The plan should be discussed at pre-submission meetings to establish application content and timelines as well as what data the applicant will have at the time of filing, and what they can provide at a later date. Once the initial application is filed, Health Canada will ensure that the applicant included their detailed plan. The applicant would also submit updates as solicited information electronically. The cover letter should refer to the Application Plan. If changes are required to labelling to reflect the new information, annotated and clean copies of the drug labels should be included.

It is expected that all information and material detailed in the Application Plan will be provided before the authorization is issued.

Applicants are encouraged to have regular communications with Health Canada.

Applications based on comparison

Applications for generics or biosimilars will only be considered under the Interim Order if the innovative drug being compared to is not available on the Canadian market (for example, not launched in Canada or marketing has been discontinued), or only available in quantities that are inadequate to address the urgent public health need related to COVID-19.

Prior to filing an application, a generic or biosimilar manufacturer is required to provide information demonstrating that the innovator’s drug is not available in sufficient quantity to supply the Canadian market.

Upon receipt of this information, Health Canada will notify the innovator that a potential application may be filed and provide them an opportunity to make representations as to whether they are able to offer the drug for sale in Canada in sufficient quantities to address the urgent public health need related to COVID-19. If Health Canada confirms they are not able or willing to meet the required market demand, the potential applicant of the submission based on a comparison would be notified that the application can be submitted.

Pursuant to subsection 14(1) of the Interim Order, a manufacturer of a new drug under Division 8 of Part C of the Regulations is not permitted to file a submission or supplement for the new drug on the basis of a direct or indirect comparison to a COVID-19 drug authorized under the Interim Order. In other words, a drug authorized under the Interim Order cannot be used as Canadian Reference Product to obtain a notice of compliance for an Abbreviated New Drug Submission under section C.08.002.1 of the Regulations or as a comparator for a biosimilar drug under C.08.002 of the Regulations.

In the case where both a notice of compliance under the Regulations and an authorization under the Interim Order are issued for a COVID-19 drug, a manufacturer of the new drug can file a submission or supplement for the new drug in respect of the matters that are approved under the notice of compliance. Updates to the labelling for indications authorized under Division 8 or changes to Chemistry and Manufacturing (Quality) data that rely on comparisons of the new drug to itself would remain acceptable.

Quality (chemistry and manufacturing) information and requirements

Given the intent to expedite the authorization of these products, the quality (chemistry and manufacturing) information package may not be as comprehensive as that of a typical drug submission. Applicants should refer to Appendix B for a list of guidance documents that provide further guidance on meeting application and information requirements.

Non-clinical information and requirements

Given the intent to expedite the authorization of these products, the non-clinical information package may not be as comprehensive as that of a typical drug submission. Additional non-clinical information may be required to demonstrate the potential for clinical effectiveness under the proposed conditions of use, and to support the safety of the COVID-19 drug. All key studies should be conducted in accordance with Good Laboratory Practices (GLPs). Applicants should refer to Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice.

Clinical information and requirements

Given the intent to expedite the authorization of these products, the clinical information package may not be as comprehensive as that of a typical drug submission. The known information to support the safety and effectiveness of the COVID-19 drug should be provided, including all available clinical trial data, and safety and efficacy summary documents.

Application information and requirements for veterinary drugs

An application for authorization of a COVID-19 drug should contain all available information to inform an assessment of the drug including evidence of its efficacy in the target species, animal safety, human safety, and quality. If the drug is to be used in a food-producing animal, information should be provided regarding the safety of drug residues in meat and other food products from the treated animal intended for human consumption.

Risk Management Plan

A Risk Management Plan (RMP) should be submitted that focuses on the safety risks for the product in the context of COVID-19 use. An RMP is a document that outlines pharmacovigilance activities and interventions to identify, characterize, prevent or minimize risks related to drug products. The RMP also contains an evaluation of the effectiveness of such risk minimization measures. Applicants should refer to Guidance Document Submission of Risk Management Plans and Follow-Up Commitments for additional information on the scope of RMPs.

The RMP in the context of the COVID-19 drugs submitted for authorization under the Interim Order can be abbreviated but should include the following:

An RMP that is reviewed and accepted as part of the application for an authorized product is expected to be implemented. If the implementation of one or more elements of an RMP is essential for the safe and effective use of the product, they could be identified as terms or conditions of the market authorization.

If the applicant has questions specific to the type of quality, safety and effectiveness information, applicants should send their inquiries to the appropriate Directorate (Office) located within Health Canada. Please refer to Appendix A for relevant contact information.

Application for COVID-19 foreign drugs

In order for a drug to be eligible to use the pathway for foreign drugs described in Section 4 of the Interim Order, the drug must be included on the List of Foreign Drugs in Relation to the COVID-19 Pandemic. Health Canada may include a drug on this list if it is deemed to be necessary or is shown to provide benefit in the context of the COVID-19 pandemic, and it has received an authorization for sale in a foreign jurisdiction such as:

Health Canada may become aware of such drugs through interactions with international counterparts or environmental scanning including dialogues with health care providers or potential drug applicants.

In order to be imported, sold, or advertised in Canada, a drug included on the list must still obtain an authorization under this Interim Order by meeting the requirements listed in Section 4. With respect to the foreign drug, the Minister must determine that all criteria outlined in the Interim Order have been met and, in the context of the COVID-19 pandemic, that the benefits of authorizing this drug outweigh the risks.

The application shall contain sufficient information and material for the Minister to render a decision whether or not to issue a COVID-19 drug authorization, on the basis of the issuance criteria in section 5 of the Interim Order. This information is highlighted in subsection 4(2) of the Interim Order.

If applicants wish to use this route to submit a drug that has been approved in a foreign jurisdiction that they consider appropriate for such authorization, they are encouraged to discuss this with Health Canada. Please refer to Appendix A for relevant contact information.

Application information and requirements

The information and material described in paragraphs 3(1)(a) to (c), (e), (i) to (k) and, if applicable, (m);

Applicants can refer to the following sections of this guidance document for more information on application requirements:

Attestation

Paragraph 4(2)(b) of the Interim Order requires the applicant to provide an attestation. The attestation must be signed and dated by an individual who has the authority to bind the applicant in Canada, certifying that the applicant has access to the information referred to in paragraph 3(1)(n) that was submitted to the relevant foreign regulatory authorities to obtain the authorization to sell the foreign drug. Appendix C provides an example of what Health Canada would look for in an attestation from an applicant.

Drug is identical to the foreign drug

Paragraph 4(2)(c) of the Interim Order requires the applicant to provide information that demonstrates that the drug is identical to, and is manufactured, prepared and packaged in the same manner as, the foreign drug.

Foreign regulatory authorization

Paragraph 4(2)(d) of the Interim Order requires the applicant to provide information that demonstrates that the sale of the foreign drug is authorized by that foreign regulatory authority. This evidence should include a copy of the formal authorization letter, including any conditions imposed, issued by the authority, as well as any review summaries authored by the authority, including details of additional measures to support pharmacovigilance or risk mitigation. If the Minister deems that the evidence of authorization by a foreign authority is insufficient to ensure that section 5 of the Interim Order is met, the Minister may request additional information under section 13 of the Interim Order, and may also decide to issue an authorization with terms and conditions under section 10.

As per submission requirements for a COVID-19 drug, a RMP should be submitted that includes a safety specification, pharmacovigilance plan, and risk minimization plan, if applicable. See the Guidance Document - Submission of Risk Management Plans and Follow-Up Commitments for additional information on the scope of RMPs. The RMP can be from a foreign source but should address all safety concerns and contains information on use in COVID-19 in the Canadian context.

If a foreign jurisdiction waives pre-market submission and evaluation requirements, this would not be considered a foreign regulatory authorization for the purposes of the Interim Order. Note that pathways that involve reduced filing requirements may not be acceptable under this provision.

Labels approved by foreign regulatory authority

Paragraph 4(2)(e) of the Interim Order requires that the applicant provides a copy of the label of the COVID-19 drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, that are approved by that foreign regulatory authority for use in connection with the foreign drug.

The applicant should submit the approved labels (including the product monograph, package inserts and inner and outer labels) approved by the foreign regulator.

Information required where an existing drug can be used for an expanded indication

The expanded indication pathway, outlined in Section 15 of the Interim Order, is initiated by the Minister without application from the applicant through the addition of a drug and its expanded indication on the List of New Drugs for Expanded Indication in Relation to the COVID-19 Pandemic (List of New Drugs for Expanded Indication).

Additions to the List of New Drugs for Expanded Indication will be based on environmental scanning by Health Canada including dialogues with health care providers and public health authorities as evidence supporting use of existing drugs in the context of COVID-19 becomes available. However, an external applicant may, through communications with Health Canada, make the Minister aware of a drug that may qualify for this process.

As the drugs qualifying for this process will already hold an authorization either through this Interim Order or a notice of compliance through the Regulations, there will already be known evidence to support the safety, efficacy (for other indications) and quality of these drugs. In order for the Minister to include the drug and its expanded indication on the list, she needs to have evidence that in the context of the COVID-19 pandemic, the benefits outweigh the risks for the expanded indication (for example, this evidence may come from clinical trials). In addition, the Minister can request any information the authorization holder(s) may have pertaining to the expanded indication relating to COVID-19.

When the Minister decides to issue an expanded indication, this information related to the authorized drug and the new indication is added to the List of New Drugs for Expanded Indication that is published by the Government of Canada on its website and is then deemed authorized.

Applicants who wish to file for a new indication under the Interim Order for an existing Canadian-authorized product can do so in accordance with section 3 of the Interim Order. Applicants can cross-reference to information on the originally authorized product, provide evidence for the new indication and provide updated labels. Applicants can also use the foreign decision pathway in accordance with section 4 of the Interim Order to add a new indication to an existing Canadian-authorized product where a foreign regulator has authorized the new use and the drug appears on the List of Foreign Drugs.

Labelling

Applicants of a COVID-19 drug shall comply with applicable labelling requirements in the Food and Drugs Act and Part A and Part C of the Regulations (A.01.014, A.01.015, A.01.60.1 to A.01.68, A.01.065, C.01.004 to C.01.011, C.01.401, C.03.202, C.03.203, C.03.206 to C.03.209, C.04.019 and C.04.020). Existing regulatory provisions relating to the labelling of veterinary drugs also apply.

For drugs that have never been authorized in Canada and are filed under the Interim Order, applicants may be asked to consider including a warning statement on the inner and outer labels, which could be displayed on any panel. This will depend on the data submitted to support the authorization and any associated terms and conditions. The recommended wording, displayed in capital letters and in a legible manner as seen below, would indicate that the authorization has been issued based on limited clinical testing in humans and/or limited quality information:

“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 DRUG BASED ON LIMITED CLINICAL TESTING IN HUMANS AND/OR QUALITY INFORMATION.”

« SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE LIÉE À LA COVID-19 SUR LA BASE D'ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN ET/OU D'INFORMATIONS SUR LA QUALITÉ. »

The warning statement could be excluded from small inner labels if there is not sufficient space but could still be included on the outer labels. For veterinary drugs, the recommended wording, displayed in capital letters and in a legible manner as seen below, would be:

“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 DRUG BASED ON LIMITED CLINICAL TESTING IN ANIMALS AND/OR QUALITY INFORMATION.”

« SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE LIÉE À LA COVID-19 SUR LA BASE D'ESSAIS CLINIQUES RESTREINTS CHEZ LES ANIMAUX ET/OU D'INFORMATIONS SUR LA QUALITÉ. »

For existing Canadian-authorized product with a new indication under the Interim Order, package inserts should be included that are usually the prescribing information document equivalent to Part I, Health Professional Information of the new Product Monograph (PM) format for new drugs. Both these documents are intended for use by a healthcare professional. In addition, the package insert should contain the information in Part III of the PM (consumer information/patient medication information). If the product is going to be dispensed in the final packaging, it would be in the best interest of the end-user (transparency, disclosure of risks) to provide Part III of the PM to them as part of the package insert.

The requirements for plain language labelling and Look-alike Sound-alike (LASA) assessment do not apply. Although it is not required, applicants are invited to provide a LASA assessment as part of a brand name assessment.

Applicants should refer to Appendix B for a list of guidance documents that provide further guidance on labelling.

Schedule D drugs

Applicants of a COVID-19 drug for humans that is listed on Schedule D of the Food and Drugs Act (biologic drugs) shall comply with the provisions to prevent cross contamination (C.04.013, C.04.014), lot release (C.04.015) and expectations for animal-derived materials (C.04.016). For Schedule D labelling requirements, please refer to the section on labelling of this guidance document.

Applicants should refer to Appendix B for a list of guidance documents that provide further guidance on Schedule D drugs.

Prescription drug

For an application for authorization for a COVID-19 drug filed under this Interim Order, Health Canada will also consider whether the drug is best sold as a prescription or non-prescription product. As per section 2, the requirements of the Regulations that determine whether a drug requires a prescription for its sale must be considered. This means that in addition to evaluating the data to determine whether the drug should be authorized for sale on the Canadian market, Health Canada will also consider whether the principles and their associated factors for prescription status apply to the drug. If any of the principles or factors apply to the drug, this is considered sufficient for the drug to be given prescription status and added to the Prescription Drug List. For an explanation of the broad principles and factors that Health Canada considers in determining whether a drug would be better sold as a prescription or non-prescription product, please refer to Determining Prescription Status for Human and Veterinary Drugs. For information on the administrative process for adding a drug to the Prescription Drug List, please refer to the Questions and Answers - Prescription Drug List.

Good manufacturing practices

Applicants should refer to Good manufacturing practices guide for drug products (GUI-0001) for information with respect to general good manufacturing practices (GMP) requirements.

As per subsection 2(1)(d) of the Interim Order, COVID-19 drugs must be manufactured in accordance with Division 2 of Part C of the Regulations with the exception of section C.02.019 that has been replaced with section 24 of the Interim Order and requires:

Furthermore, subsection 25(1) of the Interim Order indicates that importers do not need to comply with section C.02.020 (1)(a)(b) and (d) with Division 2 of Part C of the Regulations. This means importers do not need to have master production documents or other manufacturing or packaging batch documents available on-site and may rely on a batch certificate or certificate of manufacture and certificate of analysis to release product.

Importers also do not need to have stability evidence available. The shelf life must still be established in accordance with quality information submitted in the application, refer to the following sections of this guidance document for more information:

As per subsection 19(1) of the Interim Order, the authorization holder must maintain records and on-market reporting of errors and failures for the following:

As per subsection 19(2) of the Interim Order, the authorization holder must provide a summary of a record respecting any information referred to in items (a) to (c) above immediately after the authorization holder establishes the record. All information should be sent to the appropriate Office located within Health Canada. Please refer to Appendix E of the Drug and natural health products recall guide (GUI-0039) for contact information.

As per subsection 19(2) of the Interim Order, the authorization holder must provide a summary of a record respecting any information referred to in items (d) or (e) above within 15 days after the day on which the holder establishes the record. Information on reporting any domestic adverse reactions associated with an unusual failure in efficacy can be found in Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry and Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102).

Furthermore, authorization holders are encouraged to retain records about real-world safety information in a manner that can be easily shared with Health Canada.

Parenteral drugs

Authorization holders shall comply with requirements related to parenteral drugs, preservatives and sterility requirements in the Food and Drugs Act and Part C of the Regulations (C.01.064 to C.01.069).

Format for applications and amendments

All information for human drugs applications should be formatted and structured in eCTD or non-eCTD Format, depending on the product type. These applications should be formatted as per the instructions for a new drug submission (NDS). It is also recommended that applications be compiled using the Regulatory Enrolment Process, in order be able to submit via the Common Electronic Submissions Gateway. Where a manufacturer cannot comply with the formatting requirements, they may contact the Office of Submissions and Intellectual Property (OSIP) at hc.ereview.sc@canada.ca for further options and guidance.

Applications for a veterinary drug should be formatted and structured in non-eCTD Format. These applications can also be compiled using the Regulatory Enrolment Process, however, please contact OSIP at hc.ereview.sc@canada.ca in order to use this process.

Applicants should also refer to The Management of Drug Submissions and Applications, or the Management of Regulatory Submissions for veterinary drugs, for general procedures on how to file applications.

Performance standards

Applications will be prioritized and reviewed in an expedited fashion, and the time that it will take to complete the review will depend on the application itself, the volume of data to be assessed and the number of applications received (for instance, the performance standards in The Management of Drug Submissions and Applications, or the Management of Regulatory Submissions for veterinary drugs do not apply).

Additional information and material

Health Canada may, at any time, request additional information or material (including samples) from the applicant or authorization holder in order to determine whether Health Canada will move forward with the issuance, amendment or cancellation of the COVID-19 drug authorization. The applicant or holder of the authorization must provide the information in the time, form and manner specified by Health Canada.

Issuance of authorization for a COVID-19 drug

For Health Canada to grant authorization for importation or sale of the COVID-19 drug, all of the following conditions must be met:

  1. an application is submitted to Health Canada meets the requirements of section 3 or subsection 4(2) of the Interim Order
  2. all additional requested information and material (including samples and protocols of tests) is submitted to Health Canada upon request, and
  3. Health Canada has assessed the submitted information and has concluded that the applicant provided sufficient evidence to support the benefits of the COVID-19 drug and that the benefits of the COVID-19 drug outweighs the risks associated with it, and that they have committed to any additional measures needed to mitigate risks and address information gaps
    • this takes into consideration the uncertainties related to the drug in the context of an urgent public health need related to COVID-19

When the Minister decides to issue an authorization for a COVID-19 drug, she will make certain information related to the authorized drug publicly available. The authorized drug will be added to the List of Drugs Authorized by Health Canada for Use in Relation to the COVID-19 Pandemic that is published by the Government of Canada on its website and a summary document will be published to describe the rationale for Health Canada’s decision.

Drug Identification Number (DIN)

Once a COVID-19 drug has been authorized for sale in Canada, Health Canada issues a number under subsection 7(1) of the Interim Order, which uniquely identifies the following characteristics of a COVID-19 drug: Strength of Active Ingredient(s), Dosage Form and Route(s) of Administration, manufacturer, trade name and whether the drug is for human or veterinary use. Note that brand names should not be the same as a brand name for a drug that has received a DIN under the Regulations. The format for the number will be the same as for DIN issued under the Regulations.

When authorizing a new indication under the Interim Order for an existing Canadian-authorized product, a new DIN will not be issued if a distinct DIN has already been assigned under the Regulations for the same unique combination of dosage form, strength and route of administration for the COVID-19 drug.

Authorization holders should refer to Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) for additional information on DINs.

Market notification

As per section 8 of the Interim Order, the authorization holder must notify Health Canada when they first sell a drug that has been issued a number. The authorization holder must submit a completed Drug Notification Form (DNF) to Health Canada within 15 days of first selling the drug. The DNF must be filled out, signed, and dated. All pages of the DNF must be returned to Health Canada.

Authorization holders should refer to Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) for additional information and general procedures on market notification.

Notification of discontinuance

The authorization holder must submit the notification of permanent discontinuance of sale within 15 days after the sale of the drug was permanently discontinued as per section 9 of the Interim Order. The date of discontinuance is when the authorization holder last sells its drug, not when it is last sold at retail.

Authorization holders should refer to Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) for additional information and general procedures on notification of discontinuance.

For drugs that are in shortage situation, applicants can refer to the section Shortages or discontinuation of sale of this guidance document for more information on how to report discontinuance of sale.

Terms and conditions

Health Canada may, at any time, impose or amend terms and conditions on the authorization for importation or sale of COVID-19 drugs. This authority allows Health Canada to be agile and authorize a drug for market while attaching additional conditions or limitations on the authorization. These terms or conditions will be used to ensure appropriate oversight or to manage uncertainties or mitigate risks.

Submitting information required under the terms and conditions

Information regarding the fulfilment of terms and conditions that fall outside of the amendment process should be submitted in the form of a cover letter with the subject “Fulfilling Terms and Conditions” and any supporting documentation.

The documentation will be reviewed by Health Canada to determine whether the conditions have been met. Once an authorization holder provides Health Canada with satisfactory evidence that all the terms and conditions of the original authorization have been met, Health Canada will issue a letter indicating that the terms and conditions have been fulfilled, referencing the original file number/ control number.

Submitting an amendment to a COVID-19 drug authorization

Section 6 of the Interim Order states that no person can import or sell a COVID-19 drug if there are significant differences in the information about the drug from that which was initially submitted to Health Canada for authorization under the Interim Order, unless the Minister has issued an amended authorization. These changes apply to any information submitted to the Minister under subsection 3(1) of this Interim Order, other than the list of investigators, or in subsection 4(2) of this Interim Order, other than the labels approved by the foreign regulatory authority, or as a response to a request for additional information under section 13.

Changes to a drug that are “significantly different” mean that they have the potential to impact the safety, efficacy, quality, food safety (for certain veterinary drugs) and/or effective use of the drug. These would include major quality changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.

The onus is on the authorization holder to identify and communicate these changes to Health Canada via an application to amend the authorization. It is recommended that a summary of the changes referencing the original file number/ control number, compared to that which was initially authorized, is submitted.

Authorization holders can refer to Post-Notice of Compliance (NOC) Changes: Framework Document and associated companion guidance documents for additional guidance with respect to the description of “significant”.

Suspension of a COVID-19 drug authorization

Health Canada may, at any time, suspend in whole or in part, the authorization for importation or sale of a COVID-19 drug under the following conditions if:

  1. Health Canada determines that the benefits no longer outweigh the risks of the drug and that the health or safety of Canadian patients, users, animals, or any other person may be unduly affected
  2. the holder of the authorization has contravened any provision of this Interim Order or has contravened, including any terms or conditions, in relation to the drug to which the authorization relates, any provision of the Regulations or of the Food and Drugs Act or any order made under that Act, this would include not appropriately responding to requests for additional information or material
  3. in the case of an authorization that was issued based on a comparison to a foreign drug, the authorization for sale of the foreign reference product that has been issued by a foreign regulatory authority is revoked or suspended

When an authorization is suspended, the authorization holder must cease all activities permitted under the authorization.

An authorization for importation or sale under the Interim Order is subject to compliance and enforcement should Health Canada be made aware of issues of noncompliance.

Reinstatement of a COVID-19 drug authorization

When an authorization has been suspended in full or in part by Health Canada, the authorization holder must provide the information or material, in the time, form and manner specified by Health Canada, that demonstrates that the situation giving rise to the suspension did not exist or has been corrected. Upon satisfactory review, Health Canada will reinstate the authorization.

Discretionary revocation of a COVID-19 drug authorization

Health Canada can revoke an authorization for importation or sale of a COVID-19 drug in whole or in part if the authorization holder has not provided to Health Canada additional information and material (including samples) demonstrating that the situation giving rise to the suspension did not exist or has been corrected in the time, form and manner specified.

When an authorization is revoked, the authorization holder must cease all specified activities.

An authorization for importation or sale under the Interim Order is subject to compliance and enforcement should Health Canada be made aware of issues of noncompliance.

Mandatory revocation of a COVID-19 drug authorization

Health Canada will revoke an authorization for importation or sale of a COVID-19 drug if the authorization holder requests it. The applicant must submit a letter to Health Canada that explicitly makes a request for the revocation and outlines the approach that will be taken for reporting on such material that may remain available on the Canadian market at that time.

Transparency

Lists

A total of four lists, as amended from time to time, will be published on a Government of Canada website relating to this Interim Order:

Safety and efficacy evidence

Health Canada will make publicly available the safety and efficacy evidence relied upon to issue an authorization under the Interim Order respecting authorization of drugs in relation to COVID-19.

Clinical information will be released for non-commercial purposes and will have all personal information and confidential business information protected prior to publication on the portal.

Additional information

A summary document will be published on a Government of Canada website, explaining Health Canada's decision to authorize sections 3 of the Interim Order. In addition, Health Canada will publish a summary document describing supplementary information pertaining to each drug on the List of New Drugs for Expanded Indication and each drug on the List of Foreign Drugs. These documents will include Health Canada’s analysis of the known and potential benefits and known and potential risks associated with the use of the product in relation to COVID-19, as well as the directions for use.

Additionally, Health Canada will continue to publish on the Drug and health product inspections Database, the inspection outcome and the measures taken by Health Canada following a Good Manufacturing Practices Drug inspection.

Intellectual property rights

The Interim Order was designed to provide an expedited and agile temporary market authorization pathway for COVID-19 drugs, needed to address the urgent public health crisis. It supports the intent that intellectual property considerations should not delay Canadians’ access to COVID-19 treatments for the purpose of responding to the COVID-19 public health crisis.

Data protection

Data protection associated with the typical market authorization process under the Regulations does not apply to authorizations granted under the Interim Order.

Applications for authorizations filed under the Interim Order will not trigger the data protection provisions under the Regulations, and new authorized products will not be eligible to be listed on the Register of Innovative Drugs.

However, the issuance of an authorization under the Interim Order does not mean that a product containing a new chemical entity will not be eligible to receive data protection under the Regulations once the Interim Order expires. This is because an authorization of a drug under the Interim Order will not be considered an approval for the purposes of applying the definition of innovative drug under section C.08.004.1 of the Regulations. Furthermore, any drug that is issued an authorization under the Interim Order cannot be used as a Canadian Reference Product for the purposes of a submission made under the Regulations in which a drug compares itself to a drug authorized under the Interim Order. Additionally, the Interim Order does not allow an application from another drug based on a direct or indirect comparison to an innovative drug, unless the manufacturer for the innovative drug is unable to meet the Canadian market demand in sufficient quantities. Prior to allowing an application under such circumstances, Health Canada will invite the manufacturer of the innovative drug to make representations.

The Interim Order will expire after one year. To ensure Canadians maintain access to these drugs, Health Canada intends to put in place transition measures to allow for the continuation of authorizations issued under the Interim Order, to address the urgent public health need related to COVID-19. As part of this pathway, Health Canada will put in place measures to enable some products authorized under the Interim Order to seek approvals under the Regulations, once the Interim Order expires.

These transition measures will set out a process that will allow innovator companies that received an authorization under the Interim Order to be eligible to obtain a notice of compliance under the Regulations. Data protections pursuant to the regulations and patent linkage protection under the Patented Medicines (Notice of Compliance) Regulations (PM (NOC) Regulations) would be considered.

Patented Medicine (Notice of Compliance) Regulations

There is no provision under the Interim Order to link authorizations to patents through the PM (NOC) Regulations. As such, generic or biosimilar drug applications that meet the eligibility criteria for authorizations under the Interim Order will not trigger the PM (NOC) Regulations. In addition, there is no ability to list patents on the Patent Register in respect of patented products authorized under the Interim Order.

However, the issuance of an authorization under the Interim Order does not mean that a patented product would not be eligible to receive protection under the PM (NOC) Regulations once the Interim Order expires. Health Canada intends to transition eligible products authorized under the Interim Order to approvals under the Regulations once the Interim Order expires in order to consider the application of the PM (NOC) Regulations linkage regime.

Certificate of Supplementary Protection

In accordance with the Certificate of Supplementary Protection Regulations, authorizations under the Interim Order are not eligible to support an application for a Certificate of Supplementary Protection (CSP). CSP eligibility will be taken into account as transition measures are developed.

Applicants who choose to file a COVID-19 drug submission for a notice of compliance using one of the existing pathways found in the Regulations, instead of the Interim Order, will continue to be eligible to apply for a CSP.

Drug Establishment Licences (DEL)

As per paragraph 2(2)(c) of the Interim Order, Division 1A of Part C of the Regulations applies to COVID-19 drugs. As such, a person must hold a Drug Establishment Licence (DEL) authorizing any activities conducted with respect to COVID-19 drugs.

For information regarding the interpretations of the Regulations as it pertains to drug establishment licensing requirements, please consult Guidance on Drug Establishment Licences (GUI-0002). For your responsibilities regarding the DEL applications process and how Health Canada manages DEL applications, please consult the Management of Applications and Performance for Drug Establishment Licences (GUI-0127). Questions regarding DEL requirements or DEL applications for COVID-19 drugs can be sent to hc.del.questions-leppp.sc@canada.ca. Include the term “COVID-19” in your email subject line for a faster response.

Applying for a DEL under the Interim Order

Applicants submitting a DEL application are to submit their application following the guidance available in Guidance on Drug Establishment Licences (GUI-0002) and in Management of Applications and Performance for Drug Establishment Licences (GUI-0127). When submitting a DEL application for a COVID-19 drug, the applicant should include the term “COVID-19 drug Interim Order” in the subject line of their application email to help Health Canada identify the high priority application. Also, when the applicant wishes to submit the application under section 20 of the Interim Order, the application should include the following additional information:

All applications submitted under section 20 of the Interim Order will be processed in an expedited manner. Licensing decisions will be made on a case-by-case basis considering both the material submitted in the application and the necessity of the drug in addressing urgent COVID-19 related health needs.

Evidence requirements to support the GMP compliance of foreign buildings is included in the guidance document How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). Applicants that are not able to obtain documents outlined in GUI-0080 should contact Health Canada for guidance at hc.foreign.site-etranger.sc@canada.ca prior to submitting their DEL application and include “COVID-19” in their email subject line. Health Canada may consider other evidence on a case-by-case basis.

DEL terms and conditions

Health Canada has broad discretionary authority to add and amend terms and conditions to DELs issued or amended in respect to applications submitted under section 20 of the Interim Order. This will provide Health Canada with the agility to facilitate rapid access to COVID-19 drugs while mitigating risks.

DEL holders found to be in contravention of the terms and conditions of their licence will be subject to compliance and enforcement actions. Such actions will align with the legislative framework and the principles of POL-0001: Compliance and Enforcement Policy for Health Products.

DEL cancellation

DELs issued under subsection 20(1) of the Interim Order and amendments to a DEL submitted under subsection 20(2) of the Interim Order, along with any associated terms and conditions, will be automatically cancelled when the Interim Order ceases to have effect.

Transition of DELs

Applicants wishing to continue activities after the Interim Order ceases must submit an application under C.01A.005 or section C.01A.006 of the Regulations. The application will be subject to Health Canada’s regular 250 calendar day performance standard as described in Management of Applications and Performance for Drug Establishment Licences (GUI-0127). DELs issued or amended in respect to such applications will not be subject to the Interim Order. The application could be expedited if determined to be medically necessary as outlined in Management of Applications and Performance for Drug Establishment Licences (GUI-0127).

In the event applicants wish to maintain the same activities already requested under section 20 of the Interim Order, the information below should be submitted with their application to allow Health Canada to link the application with the original Interim Order application:

DEL fee remission

The Establishment Licence Fees Remission Order - Indication of an Activity in respect of a COVID-19 Drug (Remission Order) allows for the remission of fees associated with DEL applications submitted under the Interim Order. Fees will be remitted for the review of applications for a new DEL, applications to amend an existing DEL or applications for the Annual Licence Review of DELs submitted under the Interim Order.

Fees remitted for qualifying applications are specified in the Fees in Respect of Drugs and Medical Devices Order and further described in the guidance document: Fees for the Review of Human and Veterinary Drug Establishment Licence Applications.

New DEL applications or DEL amendment applications submitted under the Interim Order

Remission of the fee for the examination of an application submitted under the Interim Order may be granted for the following application types:

  1. an application for a new DEL submitted under section 20(1) of the Interim Order
  2. an application for an amendment to a DEL submitted under section 20(2) of the Interim Order

The following conditions must be met for the application to qualify for fee remission:

  1. the application must include the statement: “This application relates solely to activities in respect of a COVID-19 drug under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.”
  2. for each domestic building, each activity listed in the application will be conducted solely in respect of COVID-19 drugs, and
  3. upon the Minister’s request, the applicant provides documents demonstrating that each activity specified in the application is conducted solely in respect of COVID-19 drugs

Applications that do not meet these conditions will be subject to the DEL fee.

Annual Licence Review (ALR) applications

ALR applications submitted following the issuance of a new or amended DEL under the Interim Order may qualify for remission of the ALR fee if the following conditions are met:

  1. for domestic buildings, each activity applied for under the Interim Order is conducted solely in respect of COVID-19 drugs
  2. for buildings outside Canada (foreign buildings), each activity conducted at that foreign building for that DEL holder is conducted solely in respect of COVID-19 drugs
  3. upon the Minister’s request, the person submitting the ALR application provides documents demonstrating that conditions in 1 and 2 are met and
  4. no subsequent DEL was issued or amended using the same information as the application under the Interim Order but lacking the statement that the application was solely in respect of a COVID-19 drug

Table 1 summarizes the circumstances and timing of fee remissions for eligible applications submitted under the Interim Order.

Table 1: Fee remissions for eligible applications under the Interim Order
Application type under the Interim Order Building type Adding a new building? Adding a new activity? May qualify for fee remission? Timing of fee remission
New DEL Domestic Yes Not applicable Yes, if conditions are met. At application
New DEL Foreign Yes Not applicable Yes, if conditions are met. At application
DEL amendment Domestic Yes Not applicable Yes, if conditions are met. At application
DEL amendment Domestic No Yes Yes, the difference in fees is remitted if the new activity is more expensive and conditions are met. At ALR
DEL amendment Foreign Yes Not applicable Yes, if conditions are met. At ALR
ALR Domestic Not applicable Not applicable Yes, if conditions continue to be met. At ALR
ALR Foreign Not applicable Not applicable Yes, if conditions continue to be met. At ALR

Post-market requirements

Drugs authorized under the Interim Order are subject to all of the post-market reporting requirements in the Regulations with the exception of the Annual Summary Report and Case Reports requirement (C.01.018).

Even though the requirements for Annual Summary Reports and Case Reports do not apply, the requirement to collect and assess safety information on an ongoing basis, determine whether there has been a significant change in what is known about the risks and benefits of the drug, and notify Health Canada without delay of such changes may be required as a term or condition.

Adverse drug reaction reporting

Adverse drug reactions must be reported to Health Canada’s Canada Vigilance Program.

The authorization holder must submit reports of any domestic serious expected and unexpected adverse drug reaction and any foreign serious unexpected adverse reactions within 15 days of receiving the information (C.01.017). However, Health Canada strongly encourages authorization holders to treat adverse reactions associated with COVID-19 drugs authorized under this Interim Order as priority and submit the corresponding reports to Health Canada without delay. Authorization holders should identify in the report that the drug is a COVID-19 drug authorized under the Interim Order.

Authorization holders should refer to Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry for additional information and general procedures on how to report serious adverse drug reactions. Obtain more information on submitting reports to Health Canada electronically.

Authorization holders of veterinary drugs are encouraged to contact the Veterinary Drugs Directorate for details on how to report.

Issue-related summary reports

Health Canada may, at any time, request the authorization holder to prepare an issue-related summary report (C.01.019). An issue-related summary report is a concise, critical analysis of a specific safety or effectiveness issue. Authorization holders should refer to the guidance document Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry for information on how to prepare and submit an issue-related summary report.

Record keeping

The record keeping requirements in section C.01.020(1) of the Regulationsdo apply. Note that record keeping requirements under GMP also apply (refer to the section pertaining to Good manufacturing practices of this guidance document).

Foreign actions reporting

Authorization holders are required (C.01.050 of the Regulations) to notify Health Canada of foreign regulatory actions, including but not limited to, recalls in respect of serious risk, suspension or revocation of manufacturing or market authorizations within one of the specified foreign regulatory jurisdictions, in respect of serious risk. Authorization holders should refer to the Notifying Health Canada of Foreign Actions - Guidance Document for Industry for additional information on this reporting requirement.

Authorization holders should refer to Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102) for additional information on GVP requirements.

Shortages or discontinuation of sale

Section 18 of the Interim Order requires the authorization holder for a COVID-19 drug to report a shortage when there is reason to believe that a shortage is likely to occur or a shortage is occurring. Section 18 of the Interim Order requires the authorization holder for a COVID-19 drug in shortage to report a drug discontinuation when deciding to permanently stop the sale of the drug in Canada.

With respect to drugs for human use, authorization holders should refer to sections C.01.014.9 and C.01.014.10 of Guide to reporting drug shortages and discontinuations for additional information and general procedures on how to report drug shortages and discontinuations of sale. Authorization holders of veterinary drugs should contact the Veterinary Drugs Directorate for more information on reporting shortages.

For drugs that are not in shortage situation, applicants can refer to the section Notification of discontinuance of this guidance document for more information on how to report discontinuance of sale.

Compliance and enforcement

An authorization for importation, sale and advertisement under the Interim Order is subject to compliance and enforcement should Health Canada be made aware of issues of noncompliance or risk to health. Health Canada will take compliance and enforcement actions taking into consideration a number of factors while adhering to the legislative framework and the principles of POL-0001: Compliance and Enforcement Policy for Health Products.

Compliance with the regulatory provisions in the Interim Order will be assessed in accordance with the corresponding guidance documents. Applicants should refer to Appendix B for a list of guidance documents that provide further guidance.

Importation

Each shipment of a COVID-19 drug imported into Canada should be accompanied by a copy of the Establishment Licence and the authorization to import. These documents will facilitate transport of the COVID-19 drugs across the border, as it will be used as a signal that the drug has been authorized under this Interim Order.

Pre-positioning of COVID-19 drugs

A promising COVID-19 drug may be imported into Canada prior to that drug receiving a Canadian market authorization. This early importation, referred to as “pre-positioning”, would facilitate the immediate distribution of the drug upon authorization, making it available to Canadians as early as possible. COVID-19 drugs can only be pre-positioned if the Government of Canada has entered into a contract with the manufacturer to procure it and the Chief Public Health Official of the Public Health Agency of Canada has notified the Minister of the COVID-19 drug to be pre-positioned.

To be eligible to import a COVID-19 drug for pre-positioning, several conditions must be met.

The Chief Public Health Officer must provide a description of the drug which includes the following:

The Chief Public Health Officer must indicate that a manufacturer has filed:

In cases where the manufacturer has filed an application for market authorization to a foreign regulatory authority, the COVID-19 drug to be pre-positioned must be identical in its chemistry and manufacturing to the foreign drug for which the application was filed.

The Chief Public Health Officer must also provide the name and contact information of the drug’s manufacturer and the civic address of the facilities where the drug will be stored once imported, and the name and contact information of the drug establishment license holder who will import the drug. Additionally, the quantity of drug to be imported into Canada must also be provided.

Once all the conditions have been met, the Minister of Health will send a Letter of Acknowledgement to the Chief Public Health Official that will specify the COVID-19 drug to be pre-positioned, the quantity to be imported, the name and contact information of the drug’s manufacturer, the civic address of the facilities where the COVID-19 drug will be stored once imported, and the name and contact information of the Canadian establishment licence holder who will import the drug. To facilitate importation of the drug into Canada, a copy of this letter should be used as the main document accompanying the product. Health Canada should be contacted immediately if errors are found on the Letter of Acknowledgement, or if the Chief Public Health Official wishes to change any of the information provided as part of the initial notification. It is important the Letter is amended to reflect accurate information for the purposes of importing the drug into Canada.

An importer who pre-positions a COVID-19 drug must always hold an establishment licence, but the licence does not have to be one that that authorizes importation. The establishment licence holder must provide evidence demonstrating that foreign buildings at which the COVID-19 drug is fabricated, packaged, labelled, or tested meets Good Manufacturing Practices requirements. This information need not be submitted if the importer’s establishment licence already lists the foreign building, authorizing the same activity, category of drug, dosage form and whether or not the drug is sterile. The required information can be found in the guide entitled How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). As a pre-condition to the issuance of the Acknowledgement Letter, the establishment licence holder must provide evidence demonstrating that foreign buildings at which the COVID-19 drug is fabricated, packaged, labelled, or tested meets Good Manufacturing Practices requirements. This information only needs to be submitted if the importer’s establishment licence does not already list the foreign building, authorizing the same activity, category of drug, dosage form and whether or not the drug is sterile. The required information can be found in the guide entitled How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).

The importer responsible for pre-positioning the COVID-19 drug will be subject to certain sections in Part C, Divisions 2 to 4 of the Regulations as it relates to storage and distribution. As per Section 29 of the Interim Order, the relevant sections that apply are the following: C.02.003.1 C.02.004, C.02.006, C.02.012(1), C.02.013, C.02.014, C.02.015, C.02.021(1), C.02.022(1), C.02.023, C.02.024(1), C.03.013 and C.04.001.1.

Guidance to help importers meet regulatory requirements with respect to storage and distribution of pre-positioned COVID-19 drugs is available in the Good manufacturing practices guide for drug products (GUI-0001).

The pre-positioned COVID-19 drug cannot be distributed for use until it receives a Canadian market authorization under this Interim Order or Division 8 of the Regulations. It can, however, be moved to an alternate storage facility, as long as the Minister has been notified by the Chief Public Health Officer of the civic address of that facility. The drug that will be distributed for use must have the appropriate labelling information accompanying the product. This information must include content from the labelling approved by this Interim Order or the Regulations to allow for the product’s safe use, for example, recommended conditions of use, any warnings, contra-indications, etc.

Pre-positioned COVID-19 drugs that do not receive market authorization in Canada within the validity of this Interim Order must be destroyed or returned to the manufacturer.

Advertising

Authorization holders of a COVID-19 drug shall comply with advertising requirements in the Food and Drugs Act and Part A of the Regulations (A.01.066 to A.01.068). Specific requirements exist for advertisements of prescription drugs to consumers.

Authorization holders should refer to Marketing of drugs and medical devices for additional information.

Recalls

Authorization holders of a COVID-19 drug shall comply with the recall provision (C.01.051) of the Regulations. The Minister also has the ability to order a mandatory recall pursuant to section 21.3(1)(a) of the Food and Drugs Act.

Authorization holders should refer to Recall Policy for health products (POL-0016) and Drug and natural health products recall guide (GUI-0039) for information on recall procedures.

Orders made under the Act (Vanessa’s Law)

The Food and Drugs Act applies to drugs authorized under this Interim Order. As such, authorization holders should refer to the Amendments to the Food and Drugs Act: Guide to New Authorities (power to require and disclose information, power to order a label change and power to order a recall) for information on the Minister’s ability to:

For information about the format and content of assessments ordered under section 21.31, authorization holders should refer to Format and content for post-market drug benefit-risk assessment in Canada - Guidance document.

Appendices

Appendix A: Contact information

To help ensure that we prioritise responding to your inquiry, please include “COVID-19 drug” in the subject of your email.

Biologic and Radiopharmaceutical Drugs Directorate
Office of Regulatory Affairs (ORA)
E-mail: hc.brdd.ora.sc@canada.ca

Therapeutic Products Directorate
Regulatory Project Management Division (RPMD)
E-mail: hc.rpmd-dgpr.sc@canada.ca

Veterinary Drugs Directorate
Submission and Knowledge Management Division (SKMD)
E-mail: hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca

Natural and Non-prescription Health Products Directorate
General Enquiries
Email: hc.nnhpd-dpsnso.sc@canada.ca

For application format related inquiries:
Office of Submissions and Intellectual Property (OSIP)
E-mail: hc.osip-bppi.sc@canada.ca

For adverse reaction reporting related inquiries:
Canada Vigilance Program (CVP)

For Good Manufacturing Practices (GMP) compliance requirements related inquiries:
E-mail: GMP_Questions_BPF@hc-sc.gc.ca

For Drug Establishment Licensing (DEL) related inquiries:
E-mail: hc.del.questions-leppp.sc@canada.ca

Appendix B: Health Canada guidance documents and other reference documents

Authorization application guidance documents

General guidance documents

Safety and efficacy guidance documents

Quality guidance documents

Labelling guidance documents

Establishment licensing guidance documents

Good manufacturing practices (GMP) guidance documents

Good Laboratory Practices (GLP) guidance document

Post-Market vigilance guidance documents

Post-Notice of Compliance (NOC) Changes guidance documents

Advertising guidance documents

Disinfectants and non-prescription pharmaceuticals guidance documents and monographs

Appendix C: Application for authorization of foreign drug, attestation form (example)

Attestation

Under paragraph 4(2)(b) of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, an applicant is required to attest to having access to the information referred to in paragraph 3(1)(n) that was submitted to the relevant foreign regulatory authority to obtain the authorization to sell the foreign drug. Check () the relevant attestation.

[ ] I, the Applicant, have objective evidence to establish that I have access to known information in relation to the quality, safety and effectiveness of the drug that was submitted to the relevant foreign regulatory authority to obtain the authorization to sell the foreign drug. I submit this attestation in partial fulfillment of the application submission requirements of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

[ ] I, as a senior official of the manufacturer of this application, hereby attest that I have direct knowledge of the item checked above and declare that these identified statements are true and that the information provided in this application and in any attached documentation is accurate and complete.

Where a person is named in Item X of this application, I hereby authorize that person to submit this application to the Minister on my behalf. I further authorize Health Canada to direct all correspondence relating to this application to the person named in Item X of this application.

Name:
Title:
Signature:
Date:

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