Forward Regulatory Plan 2021-2023: Regulatory Proposal to Transition the Interim Orders Respecting Shortages of Health Products

Title of Regulatory Initiative

Regulatory Proposal to Transition Interim Orders Regarding Shortages of Health Products

Enabling Act

Food and Drugs Act

Description

On March 1, 2021, the Minister of Health made the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. This Interim Order (IO) came into effect upon signing and remains in force for a year.

This IO repealed and replaced the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 that the Minister of Health made on March 30, 2020. The new IO extends, clarifies and modifies certain measures from the first interim order

Interim Order No 2:

On October 16, 2020, the Minister made the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19. The Interim Order came into effect upon signing and remains in force for a year. This Interim Order:

On November 27 2020, the Minister of Health made the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply). The Interim Order came into effect upon signing and remains in force for a year. This Interim Order:

New regulations or regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations are being proposed to contribute to ensuring that authorizations, obligations and oversight made possible by these Interim Orders continue uninterrupted after they expire.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation plan.

The proposed regulatory changes will continue to align Health Canada’s emergency provisions with global best practices to authorize unapproved products and track or prevent shortages of drugs and medical devices.

Potential impacts on Canadians, including businesses

The proposed regulatory changes are necessary to contribute to ensuring that:

Consultations

Due to the fact that the Interim Orders are only temporary in nature, an expedited regulatory development process is anticipated to introduce regulations that will preserve authorities granted under the Interim Orders. Policy consultations and stakeholder engagement on the proposed transition were conducted in January 2021.

Health Canada will seek an exemption from pre-publication in the Canada Gazette, Part I.

The publication of the regulatory amendment in the Canada Gazette, Part II, is expected to take place in fall 2021.

Further information

Stakeholders can refer to the Interim Order No. 2 Respecting Drugs, Medical Devices, and Foods for a Special Dietary Purpose, the Interim Order Respecting Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, and the Interim Order Respecting Drug Shortages (Protection of the Drug Supply) for details of the regulatory authorities being sought by regulations in Canada Gazette, Part II.

Additional information can be requested from the departmental contact.

Departmental contact information

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 343-540-8524
Email: hc.prsd-questionsdspr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory

February 2021

Consult Health Canada's acts and regulations web page for:

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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