Draft for consultation: Guide on the exceptional importation and sale of drugs in response to drug shortages and discontinuations (GUI-148): Overview

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.

Document change log:
Date Nature of and/or reason for change:

YYYY/MM/DD

Broaden the scope of the drugs eligible for this framework, including drugs produced domestically for foreign markets and foreign authorized drugs in response to discontinuations. It also clarifies requirements for the regulated parties related to adverse reactions.

2022/03/02 Sections C.01.014.8 and C.10.004 to C.10.012 were added making exceptional importation a permanent pathway.

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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.

Sections C.01.014.8 and C.10.004 to C.10.012 of the Food and Drug Regulations (FDR) allow for the exceptional importation and sale of foreign authorized drugs in response to drug shortages.

Exceptional importation and sale refers to both the importation and sale of foreign authorized drugs from other countries and the sale of foreign authorized drugs that are manufactured in Canada.

Drugs sold under this framework are authorized in and labelled for a foreign market but have been manufactured according to quality standards similar to those required in Canada. Drugs allowed for importation or sale under this framework may be sold until their expiry. Drugs allowed for importation or sale under this framework are not eligible to extend expiry dates.

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

Purpose

This guidance document is meant to help drug establishment licence (DEL) holders involved in the exceptional importation and sale of drugs understand how to comply with the FDR. This document is intended to help you understand sections C.10.004 to C.10.013 (Exceptional Importation and Sale regulations) of the FDR by outlining:

Aspects of this document also provides guidance for pharmacists and retailers.

Scope

Exceptional Importation and Sale regulations apply to foreign authorized drugs that are acceptable substitutes for a drug with a Drug Identification Number (DIN) that:

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.

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