Draft for consultation: Guide on the requirements for providing information related to drug shortages (GUI-0146)

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.

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Overview

Introduction

Since 2021, Food and Drug Regulations (FDR) have contained an authority for the Minister to require certain information upon request, in response to a drug shortage or risk of a shortage in Canada that could present a risk of injury to human health.

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.

We work with stakeholders across the drug supply chain to:

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

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

Purpose

This guidance document will help regulated parties (marketed authorization holders (MAHs) and drug establishment licence (DEL) holders) understand how to comply with the regulations in relation to the obligation to provide information related to a drug who is in shortage or at risk of a shortage.

Specifically, it will help you understand section C.01.014.94 of the FDR by outlining:

Scope and application

Section C.01.014.94 applies to any drug (defined in Section 2 of the Food and Drugs Act (FDA) that has a Canadian drug identification number (DIN), is in shortage or at risk of shortage and for which a shortage could present a risk of injury to human health.

In this context, the definition of drug could apply to any prescription or over-the-counter product that has been given a DIN. It can also apply to a DIN product used in the veterinary field that could present a risk of injury to human health if in shortage.

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

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 MAHs and DEL holders

Section C.01.014.94 of the FDR applies to MAHs and DEL holders. For more information on when DELs are required and how to obtain one, consult the Guidance on Drug Establishment Licences (GUI-0002).

In accordance with the regulations, MAHs and DEL holders must provide the requested information on a drug who is in shortage or at risk of a shortage to Health Canada in the time and manner communicated by us.

Responsibilities of Health Canada

Health Canada is responsible for determining the drugs for which information is required in order to prevent or mitigate a shortage or risk of a shortage that could present a risk of injury to human health. We will:

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

In this section, we provide the provision in the FDR (section C.01.014.94), followed by an interpretation.

Provisions to provide information

Regulatory text

The Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug- or any person who holds an establishment licence in respect of a drug in the case where a drug identification number has been assigned under that subsection provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

  1. there is a shortage or risk of shortage of the drug
    1. (a.1) a shortage of the drug, if it were to occur, could present a risk of injury to human health
  2. the information is necessary to establish or assess
    1. the existence of a shortage or risk of shortage of the drug
    2. the reason for a shortage or risk of shortage of the drug
    3. the effects or potential effects on human health of a shortage of the drug or
    4. measures that could be taken to prevent or mitigate shortage risks associated with the drug and
    5. measures that could be taken to mitigate the impacts of a shortage of the drug and
  3. the manufacturer or licensee will not provide the information without a legal obligation to do so. (subsection C.01.014.94 (1))

Interpretation

A person is an individual or an organization as defined in section 2 of the Criminal Code.

Health Canada will act on behalf of the Minister in assuming the responsibilities in this guidance document.

Three conditions must be met for Health Canada to require the MAH or DEL holder to provide information on a drug shortage or risk of a drug shortage that is in their control. We must have reasonable grounds to believe that:

Health Canada considers a number of factors when determining:

For example, we may consider the information available in the mandatory drug shortage report of a shortage.

Note: Health Canada works with stakeholders from across the drug supply chain to address shortages and risk of shortages that could present a risk of injury to human health. Our initial approach will generally be to request that the MAH or DEL holder voluntarily share information on shortages, as this better helps to mitigate shortages.

Scope of information that must be provided

Health Canada's authority under these regulations to require information from the MAH or DEL holder is limited to information within their control.

The information we request may include, for example:

Process for providing information

We will give the MAH or DEL holder instructions for providing the information, including a timeframe for response.

A request for required information will include:

A response from the MAH or DEL holder must be submitted by the deadline in the format specified. We may follow up with more questions if needed.

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.

Drug identification number (DIN): An 8-digit numerical code assigned by Health Canada to each drug product marketed under the FDR.

A DIN uniquely identifies the following product characteristics:

Establishment licence: Refer to the definition for drug establishment licence.

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 manufacturer or distributor definition

Person: An individual or an organization as defined in section 2 of the Criminal Code. (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. (FDR, C.01.014.8 (2))

Resources

Legislation and regulations

Policies and guides

Web pages and associated documents

Contact us

Contact the Health Product Shortages Directorate by email at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca

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