Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister on March 30, 2020.
The Interim Order allows the Minister to permit the exceptional importation and sale of: (1) drugs, including biocide drugs (such as hand sanitizers and disinfectants) but not natural health products (NHPs); (2) medical devices; and (3) foods for special dietary purposes (e.g., infant formula). Certain Canadian requirements (including requirements for pre-market review and compliant labelling), will not apply in respect of listed products provided they are manufactured according to standards comparable to Health Canada’s regulatory requirements.
The Interim Order also allows the exceptional sale of an unapproved medical device or food for a special dietary purpose that is manufactured in Canada when the product is needed to respond to a shortage.
The Minister will maintain up-to-date lists of the drugs, medical devices, and foods eligible for exceptional importation and selling on Health Canada’s website.
Any importer who intends to use the exemptions in this Interim Order must notify the Minister at least five days before importation. These products will still be subject to some of the requirements set out in the Food and Drugs Act and its Regulations, including reporting adverse drug reactions, recall requirements, and mandatory problem reporting (medical devices).
The following summarizes the exemptions for specific classes of health products.
The Interim Order refers to “designated drugs” which are included on the List of Drugs for Exceptional Importation and Sale. Designated Drugs are eligible for the exceptional importation and sale provisions provided for in the Interim Order. The Minister will consider adding a drug to the list if:
- it is experiencing a “Tier 3 shortage”, as defined by the Multi-Stakeholder Steering Committee Protocol on Notification of Drug Shortages;
- the product is manufactured in accordance with GMP requirements; and
- companies that are importing and selling the drugs have a valid drug establishment licence.
Manufacturers can submit a proposal to add a product (except NHPs and biocide drugs) to the list of designated drugs.
Additionally, the Interim Order refers to “designated medical devices” which are included on the List of Medical Devices for Exceptional Importation and Sale. Designated medical devices are eligible for the exceptional importation and sale provisions provided for in the Interim Order.
The Interim Order also introduces a mandatory mechanism for the Minister to be notified of shortages of medical devices considered to be critical during the COVID-19 pandemic.
To submit proposals to add a medical device to the list, email the completed Medical devices interim order request form and copies of labels to: firstname.lastname@example.org.
The Interim Order modifies certain application requirements to allow for the expedited authorization of biocide drugs that irreversibly destroy or reduce viruses such as SARS-CoV-2 (such as hard surface disinfectants and hand sanitizers). The Interim Order exempts anyone conducting activities solely respecting biocide drugs from the requirement to hold a drug establishment licence.
For those interested, Health Canada has published a guidance document on the application of the Interim Order for foods for a special dietary purpose. The list of foods for a special dietary purpose for exceptional importation and sale can be found here.
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, financial institutions, life sciences and healthcare, technology and innovation, and transport.