Draft for consultation: Guide to reporting drug shortages and discontinuations (GUI-0120)
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
- Introduction
- Purpose
- Scope and application
- Sex- and gender-based analysis plus (SGBA Plus): Advancing equity, diversity and inclusion
- Note about guidance documents in general
Introduction
Since 2017, the Food and Drug Regulations (FDR) require manufacturers to report actual and anticipated drug shortages and discontinuations to the Drug Shortages Canada website.
Health Canada is responsible for helping people in Canada maintain and improve their health. This is done, in part, through its 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.
To help prevent or mitigate an actual or anticipated shortage or discontinuation, it is necessary to have information as early as possible. Mandatory reporting:
- creates greater transparency around shortages and discontinuations for everyone
- helps the health care system prepare for gaps in supply
- leads to the development of strategies to prevent or mitigate the impact to health of a drug shortage or discontinuation
Examples of mitigation strategies that can be considered, whenever possible and appropriate, include:
- assessing the feasibility of extending the expiration dates of existing Canadian authorized drugs and
- exploring access to foreign-authorized drugs to address shortages under the exceptional importation and sale pathway
Timely notification and communication are essential to managing drug shortages and discontinuations. Mandatory reporting supports this by making information publicly available.
Learn more about drug shortages and the roles of various parties in addressing them.
Purpose
This guidance document will help drug market authorization holders (MAHs) understand how to comply with the regulations.
Specifically, it will help you:
- comply with sections C.01.014.8 to C.01.014.9 and C.01.014.92 to C.01.014.93, which focus on mandatory reporting of drug shortages and discontinuations to the Drug Shortages Canada website
- understand the requirements for pre-market review for dormant drugs and recommencing sale following 12 consecutive months of not selling
If Health Canada requires more information on a shortage, our first approach will generally be to ask companies to share information voluntarily. When information is not provided voluntarily, Health Canada may use its regulatory authorities to compel drug establishment licence (DEL) holders or MAHs to do so.
There are other reporting requirements for DEL holders that experience a surge in demand for a drug.
Visit:
- Drug Shortages Canada
- Draft for consultation: Guide on the requirements for providing information related to drug shortages (GUI-0146)
- Draft for consultation: Guide to reporting drug demand surges
Scope and application
Sections C.01.014.8 to C.01.014.9 and C.01.014.92 to C.01.014.93 of the FDR apply to the following drugs:
- drugs listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances Act
- drugs on the Prescription Drug List
- drugs listed in Schedules C and D of the Food and Drugs Act (Act)
- known as radiopharmaceuticals and biological drugs
- drugs that are permitted to be sold without a prescription, but that are administered only under a practitioner's supervision
- commonly referred to as "ethical" drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents)
- drugs that are set out in Part 1 and 2 of the List of Drugs for the Purposes of the Definition "Drug" in Section C.01.014.8 of the FDR (Expanded Scope List)
Note: The Expanded Scope List is incorporated by reference into the FDR and is updated as needed. Regulations outlined in this guidance document apply to drugs as soon as they are added to the list. Regulated parties will be notified before a drug is added to the list.
Learn more:
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:
- Sex- and gender-based analysis plus
- Health portfolio sex and gender-based analysis policy
- Take the gender-based analysis plus course
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.
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