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
Food and Drugs Act
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This IO repealed and replaced the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 that the Minister of Health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:
- Authorizes exceptional importation of drugs, biocides, medical devices, or foods for a special dietary purpose
- Mandates reporting of select medical device shortages
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:
- Authorizes the Minister to require any person who sells a drug to provide information about a shortage or potential shortage of that drug caused or exacerbated, directly or indirectly, by the COVID-19 pandemic
- Authorizes the Minister to add or amend terms and conditions to certain authorizations to sell a drug for the purpose of preventing or alleviating a shortage caused or exacerbated, directly or indirectly, by the COVID-19 pandemic
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:
- Prohibits the sale of certain drugs for consumption outside of Canada if doing so could cause or exacerbate a drug shortage
- Authorizes the Minister to request that a manufacturer or authorization holder provide information about a drug either in shortage or at risk of shortage
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:
- Canadians are protected from the significant risk to their health as a result of health product shortages; and
- Any regulatory obligations or other requirements set up under the Interim Orders continue uninterrupted after the Interim Orders expire.
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.
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
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Date the regulatory initiative was first included in the Forward Regulatory
Consult Health Canada's acts and regulations web page for:
- a list of acts and regulations administered by Health Canada
- further information on Health Canada's implementation of government-wide regulatory management initiatives
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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