Health Canada is taking measures to help expedite the importation and sale of certain licensed products required to combat COVID-19.
Expedited review of Health Product Submissions and Applications
Health Canada has announced that it will expedite the review of any COVID-19 related vaccines, therapeutic products and other health product submissions and applications. Until a vaccine or therapeutic product is available on the Canadian market, the Special Access Program will continue to be available for COVID-19 related treatments.
Submissions or applications to Health Canada should be directed to the appropriate bureau using the contact information found on this page.
Diagnostic tests and medical devices
The Minister of Health has signed an Interim Order to expedite market access for COVID-19 related medical devices. The Interim Order simplifies the requirements for approval of a medical device. Class III and IV devices will also have to provide details of the manufacturing materials and its history of sales. The Interim Order allows Health Canada to look to foreign regulatory approvals in deciding whether to approve an application for the importation or sale of COVID-19 related medical devices.
Under the Interim Order, the Minister must issue the authorization for importation or sale if the following requirements are met:
- the applicant has submitted an application to the Minister that meets the prescribed requirements in the Interim Order
- the applicant has submitted to the Minister all additional information or material, including samples, requested by the Minister;
- the Minister has sufficient evidence to support the conclusion that the benefits associated with the COVID-19 medical device outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the urgent public health need; and
- the Minister determines that the health or safety of patients, users or other persons will not be unduly affected.
Health Canada has already approved the importation and sale of two commercial COVID-19 diagnostic tests under the Interim Order.
The Interim Order will remain in effect for a minimum of 14 days, at which point it can be extended for up to one year. The full text of the Interim Order, including the application requirements, is available online.
Disinfectants, Hand Sanitizers, Personal Protective Equipment and Swabs
As an interim measure Health Canada is also expediting access to certain supplies, including: 1) disinfectants; 2) hand sanitizers; and 3) Class I personal protective equipment (such as masks and gowns) and swabs for testing.
Disinfectant products are classified as non-prescription drugs. Hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients. Class I personal protective equipment and swabs are regulated as medical devices in Canada. Typically, these products require authorization from Health Canada before they are sold in Canada and importers require a Drug Establishment Licence or Site Licence for NHPs.
Health Canada will facilitate the importation of the following:
- Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling).
- Products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.
Companies are required to maintain records to facilitate product recalls if needed.
Thank you to Daniel Weiss for his help in drafting this article.
For more information on the legal implications of COVID-19, please consult our COVID-19 Hub. As a full service global firm with offices across Canada, Norton Rose Fulbright is closely monitoring this evolving situation over a number of practice areas including employment and labour, risk advisory, banking and finance, corporate, M&A and securities, and dispute resolution and litigation, and across a variety of industries including energy, infrastructure, mining and commodities, financial institutions, life sciences and healthcare, technology and innovation, and transport.