Draft for consultation: Guide to reporting drug demand surges

This page is for consultation purposes only and may change. Learn about the consultation and how to provide your feedback. The consultation closes on March 8, 2025.

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.

On this page

Overview

Introduction

Health Canada is responsible for helping people in Canada maintain and improve their health. This is done, in part, through our commitment and actions to help address and mitigate the harm to public health caused by drug shortages. Our goal is to help ensure that people in Canada have access to the drugs they need when they need them.

Drug shortages and discontinuations can have a negative impact on patients, caregivers, health care providers and the health care system. Since March 2017, market authorization holders (MAHs) have been mandated to report actual and anticipated drug shortages and discontinuations to Drug Shortages Canada.

Some drug shortages are caused by increases in demand. When a drug establishment licence (DEL) holder who imports or wholesales a drug reports a significant increase in demand to Health Canada, it can provide important signals of potential or actual shortages. We will use this information to protect people in Canada from the harm that shortages present and will work with partners to determine and implement shortage mitigation measures, as needed.

Examples of mitigation strategies that can be considered, whenever possible and appropriate, include:

Section C.01.014.91 of the Food and Drug Regulations (FDR) creates a framework to require DEL holders who import or wholesale a drug to report significant increases in demand. These are also known as demand surge reporting requirements. This framework would apply to drugs for which a shortage could present a serious risk of injury to human health.

Learn more about drug shortages and the roles of various parties in addressing them.

For related information on Health Canada's authority to compel market authorization holders and DEL holders to provide information related to drug shortages, consult:

Purpose

This guidance document sets out Health Canada's interpretation of the requirements in sections C.01.014.8 to C.01.014.91 of the FDR.

It will help regulated parties (DEL holders who import or wholesale a drug) comply with the demand surge reporting requirements. It also helps ensure that we enforce the rules fairly, consistently and effectively.

This guidance document will outline:

Scope

Inclusions

Sections C.01.014.8 and C.01.014.91 of the FDR apply to the following drugs for which a shortage could present a serious risk of injury to human health:

Health Canada interprets the serious risk of injury to human health due to a shortage as the likelihood that interruption, lack or delay of treatment due to a shortage could cause serious harm to human health.

Elements that determine the seriousness of the harm caused by the interruption, lack or delay in treatment due to a shortage include, but are not limited to, an injury that:

The Critical and Vulnerable Drug List (CVDL) contains drugs for which a shortage could present a serious risk of injury to human health. Use this list to help you determine if demand surge reporting is required for the drug that you import or wholesale.

Learn more about how Health Canada develops the list of drugs for which a shortage could present a serious risk of injury to human health:

Exclusions

The following products are excluded from the scope of these provisions:

Sex- and gender-based analysis plus (SGBA Plus): Advancing equity, diversity and inclusion

Health Canada has a formal, corporate commitment to applying a sex- and gender-based analysis plus (SGBA Plus) approach to develop, implement and evaluate our activities. This includes our research, surveillance, legislation, policies, regulations, programs and services. This is in keeping with the federal government's commitment to gender-based analysis plus (GBA Plus).

The SGBA Plus process is an intersectional approach to assess how a range of factors interact and intersect with each other and broader systems of power. Examples of factors are sex, gender, age, race, ethnicity, socioeconomic status, disability, sexual orientation, cultural background, migration status and geographic location.

Conducting this analysis helps us to understand how intersecting identity factors, histories, power relations, distribution of resources and individuals' lived realities contribute to differences in accessing health-related resources and health outcomes. By applying SGBA Plus, we can engage in responsive and inclusive health research and develop policies, services, programs and other initiatives to promote greater health equity.

When engaging in this regulatory framework, we encourage you to conduct an SGBA Plus analysis and also take necessary steps to mitigate any possible negative impacts on particular groups.

Learn more about SGBA Plus analysis and assessment:

Note about guidance documents in general

Guidance documents provide assistance to industry on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that Health Canada may consider alternative approaches to meeting the regulatory requirements that stakeholders may propose. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. Stakeholders should discuss their proposals with Health Canada in advance so that the regulator can determine whether the applicable statutory or regulatory requirements can be met.

In accordance with its regulatory authorities and its mandate under the Food and Drugs Act, Health Canada may request other information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the relevant sections of the regulations and other applicable guidance documents.

Responsibilities of regulated parties and Health Canada

Responsibilities of DEL holders who import or wholesale

DEL holders who import or wholesale a drug are responsible for:

Learn how a significant demand surge is defined.

DEL holders for the activity of distribution and market authorization holders (MAHs) are required to report a drug shortage.

For more information, consult:

Responsibilities of Health Canada

Health Canada is responsible for:

We will maintain the confidentiality of any protected information in accordance with the laws governing the Government of Canada.

We conduct compliance and enforcement activities related to these regulatory requirements as per our Compliance and enforcement policy for health products (POL-0001).

Understanding the regulations

Assessing if a significant demand surge has occurred

A significant demand surge occurs when monthly volume of sales in Canada for a drug in scope has increased by at least 250% within a month, compared to the volume of sales in the same month in the previous calendar year. The month in the previous year is known as "the reference period" while the month of reporting is known as "the designated period".

Example:

When to report

If you determine that a significant demand surge has occurred for a drug for which a shortage could present a serious risk of injury to human health, you must:

We will follow up with questions and requests for information, if needed.

You do not have to report demand surges if 12 months have not elapsed since the day on which you first sold the drug in Canada. This is because a reference period has not been established.

Learn more about the exemptions from reporting.

What to report

As per subsection C.01.014.91(1) of the FDR, the report must contain the following information:

  1. the name and contact information of the DEL holder
  2. the drug identification number assigned for the drug
  3. the drug's brand name and proper name or, if it does not have a proper name, its common name
  4. the proper names of the drug's medicinal ingredients or, if they do not have proper names, their common names
  5. the drug's therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for the drug
  6. the drug's strength
  7. the drug's dosage form
  8. the quantity of the drug contained in its package
  9. the drug's route of administration
  10. the date on which the increase in demand began
  11. the reason for the increase in demand, if known

As a best practice, we recommend that you maintain monthly records that quantify the demand increase (in both units and percentage) and show the reason for the demand increase. We also recommend that you develop and maintain procedures for keeping records for significant demand surge reporting.

Exemptions from reporting

You do not have to submit a demand surge report for a drug in scope if:

Example:

Definitions

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 FDR, as applicable.

Import:
To import into Canada a drug for the purpose of sale.

Incorporation by reference:
A term used to describe a mechanism that 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:

Incorporation by reference can also be used to align with provincial and territorial regulations and to achieve international cooperation on matters of trade, without compromising health and safety.

Manufacturer or distributor:
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 (FDR, A.01.010).

Market authorization holder (MAH):
Refer to definition for manufacturer or distributor.

Person:
An individual or an organization as defined in section 2 of the Criminal Code.

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

Wholesaler:
A person who is not a distributor described in section C.01A.003 of the FDR and who sells any of the following drugs other than at retail sale:

Resources

Legislation and regulations

Policies and guides

Web pages and associated documents

Contact us

To submit a demand surge report, email us at drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.

For questions about drug shortage and discontinuation regulations, email the Health Product Shortages Directorate at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.

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