Ensuring predictability for exceptionally imported health products: Notice to industry
From: Health Canada
When it comes to supplying COVID-19 drugs, medical devices and foods for a special dietary purpose, companies need to be able to plan ahead. Health Canada understands this. That is why it is proposed that the Interim Order Respecting Drugs, Medical Devices, and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO) will be remade.
The purpose of this notice is to advise stakeholders that Health Canada intends to:
- continue regulatory oversight provided by the IO until at least the fall of 2021
- conduct a consultation on parts of the IO
- propose regulatory amendments that would allow many of the flexibilities provided by the IO to continue after the fall of 2021
On this page
- Policy changes to be proposed under the second interim order (March 2021 through fall 2021)
- Proposed plan to normalize authorities after the fall of 2021
- Next steps
- Contact us
In March 2020, Health Canada made the Interim Order Respecting Drugs, Medical Devices, and Foods for a Special Dietary Purpose in Relation to COVID-19. This was required to respond to the urgent need for access to health products and to allow the department to be informed about medical devices shortages during the COVID-19 pandemic.
An IO is one of the fastest mechanisms available to the federal government to help make health products available to address public health emergencies.
This IO allows Health Canada to permit the exceptional importation and sale of drugs, medical devices and foods for a special dietary purpose. These items may not fully meet Canadian requirements, such as licensing and labelling, but are manufactured to comparable standards in foreign jurisdictions. The IO also requires industry to report shortages of medical devices related to COVID-19 to Health Canada in order for effective mitigation of potential risks.
The COVID-19 pandemic has not ended. For this reason, Health Canada is planning to remake the IO before it expires in March 2021. The flexibilities and regulatory oversight provided by the IO would continue until at least the fall of 2021, with minor changes to account for lessons learned and feedback received from stakeholders.
Health Canada intends to propose regulatory amendments that would allow the authorities provided by the IO to continue after the fall of 2021.
Policy changes to be proposed under the second interim order (March 2021 through fall 2021)
Consultations will happen in January and February 2021 on possible revisions to the IO that would:
- address concerns about the availability of information for safe use in both official languages for exceptionally imported products
- align IO definition for biocides with what Heath Canada is proposing in the future
- clarify responsibilities for mandatory medical device shortage reporting
Other changes may be made based on consultations.
Proposed plan to normalize authorities after the fall of 2021
Health Canada intends to advance regulatory amendments to the Food and Drug Regulations and the Medical Device Regulations. These would allow the authorities provided by the IO and by the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 to continue after the fall of 2021.
These proposed changes would seek to maintain:
- the exceptional importation pathways for drugs and medical devices
- the authorized status of previously authorized drugs and medical devices
- medical device shortage reporting requirements
- authorities to compel information for drugs and medical devices
- authorities related to applying terms and conditions on the authorizations for drugs
Health Canada does not intend to maintain permanently the provisions for the exceptional importation of foods for a special dietary purpose. If stakeholders wish to continue importing foods for a special dietary purpose once the transition regulations come into force, they would be required to go through the normal regulatory process.
Health Canada will consult with industry stakeholders, health system partners and other government departments beginning in January. This notice will be updated and provide links to information on these consultations and any related measures, as required.
For more information, please contact us by email at firstname.lastname@example.org.
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