Health Canada Responds to COVID-19: Here’s What You Need to Know About its Expedited Approval Processes
In light of Canada’s exceptional and urgent need for critical personal protective equipment and sanitizer products, Health Canada has significantly streamlined the regulatory requirements associated with the manufacture and import of certain natural health products and medical devices.
Note also that the Canadian Border Services Agency has compiled a list of medical supplies used in the COVID-19 response, and their associated tariff classifications, to facilitate the importation of these critical resources. This list can be accessed here, along with instructions with respect to the declared value for duty of these goods, and the circumstances under which emergency importations may be eligible for duty and tax relief.
Fast-Tracking the Approval of Hand Sanitizers and Other Natural Health Products
Generally speaking, hand sanitizer and associated sanitizer products (sprays, cleaners) are classified as Natural Health Products (“NHP”) pursuant to the Natural Health Products Regulations (“NHPR”). Under normal circumstances, these products can only be distributed in Canada if they have been approved by Health Canada as meeting various prescribed standards regarding the manufacturing process, label content, efficacy, etc., and have been issued a Natural Product Number. Similarly, the manufacturing process itself for NHPs is typically subject to licensing and other regulatory compliance requirements.
Distribution of Unauthorized Hand Sanitizers
Given the scarcity of these sanitizer products, and the urgent need to increase the supply available to front-line healthcare workers, Health Canada has made the decision to relax some of the requirements otherwise applicable under the NHPR. In short, Health Canada will now allow certain products to be distributed in Canada, including:
- Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements; and
- Products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.
Importers who currently have a Drug Establishment Licence or Site Licence to conduct activities related to hand sanitizers and disinfectants are required to notify Health Canada in advance that they will be importing products and must maintain records that will facilitate product recalls, if needed.
A list of products that are permitted to be sold in Canada under this interim regime that may not fully meet labeling, licensing or packaging requirements is available here.
Companies that are seeking to manufacture, package, label and/or import alcohol-based hand sanitizers in Canada must apply for and receive product authorization, which will result in the issuance of a Site Licence on an expedited basis.
New Manufacturers or Distributors of Hand Sanitizers
Recognizing the Canadian business community’s desire to support efforts to combat COVID-19, and the fact that many facilities are shifting production from products like alcoholic beverages and perfumes to hand sanitizers, Health Canada has created four expedited approval channels:
- If a manufacturer already has a Site Licence for manufacturing, packaging, labeling, and/or importing NHPs and is adding a hand sanitizer to its product line with the intention of distributing it to the public, the manufacturer is required to apply for a Product Licence.
- Companies that intend only to distribute alcohol-based hand sanitizers made by another company need to apply for a Product Licence.
- Companies that intend only to manufacture, package, label and/or import alcohol-based hand sanitizers on behalf of another company need to apply for a Site Licence.
- Companies that do not manufacture or import Natural Health Products and would like to manufacture and sell alcohol-based hand sanitizers to the public, need to apply for both a Product and Site Licence.
Further detail with respect to these approval channels is available from Health Canada here.
Note: This expedited approval process is available only for alcohol-based hand sanitizers that contain the following medicinal ingredients: Ethanol (60-80% v/v, also known as anhydrous alcohol, ethyl alcohol, grain alcohol) and Isopropanol (60-75% v/v, also known as isopropanol, 2-propanol).
Streamlining the Registration and Importation of Masks and Respirators
Masks and respirators are considered essential products by Health Canada during the COVID-19 outbreak as they help to slow the spread of the disease and improve protection for health care providers. Health Canada has issued a streamlined process for the registration, importation, and distribution process of medical devices, including masks and respirators that have not been approved in Canada and do not fully comply with the applicable standards.
Fast-Tracking the Approval of Masks and Respirators in Canada
Under normal circumstances, companies that manufacture, import or distribute medical devices are required to obtain a Medical Device Licence (“MDL”) and a Medical Device Establishment Licence (“MDEL”). An MDL is issued to the manufacturer of Class II, III, or IV devices. This licence is not required for Class I medical devices (the class in which surgical and N95 masks are usually classified). An MDEL is issued for the activities of importing and selling medical devices in Canada. It is issued pursuant an establishment certifying that it meets certain requirements and are then inspected for compliance.
Currently there are two expedited authorization processes in place with respect to Class I medical devices: for the manufacturing and for the import and distribution.
The review and authorization process for the import or sale of masks and respirators is conducted under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. Essentially, the Interim Order allows Health Canada to depart from strict requirements under Part 1 of the Medical Device Regulations, especially in cases where the device is authorized by a foreign regulatory authority and such authorization has not been suspended.
For further details on the review and authorization processes please see the Guidance on Optimizing the use of masks and respirators during the COVID-19 outbreak.
Exceptional Importation and Sale of Non-Compliant Masks and Respirators in Canada
Given the urgent and immediate need for personal protective equipment, manufacturers and importers may wish to import into Canada masks and respirators that are technically considered to be non-compliant. Health Canada recognizes that certain types of non-compliant personal protective equipment may be effective in providing a sufficient level of protection from the spread of the coronavirus. Accordingly, Health Canada announced that it may allow for importation of some categories of non-compliant masks and respirators, such as those that are past their expiry date, or those that do not have a bilingual label. The review process is conducted under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.
To import non-compliant masks and respirators, manufacturers and importers should:
- Complete the Medical devices interim order request form;
- Include “COVID – Notification” in the subject line of the e-mail to help Health Canada fast-track requests; and
- E-mail the completed form along with a copy of the product label to [email protected].
3D Printing of Masks and Face Shields
The public, including various organizations, may employ innovative manufacturing approaches, such as 3D printing, to produce masks, face shields and other personal protective equipment for healthcare workers. In response to these incentives, Health Canada issued recommendations for those intending to 3D print such equipment. The recommendations, although not mandatory, provide useful guidance on the standards that could be consulted when manufacturing the 3D medical devices.
False and Misleading Advertising in Connection with COVID-19-Marketed Products
Notwithstanding Health Canada’s expedited procedures developed in connection with COVID-19 regulated products, it is still important to monitor performance-type claims associated with these goods. Indeed, Health Canada has begun enforcement on false and misleading claims around products advertised as preventing, treating or curing COVID-19. Health Canada is also coordinating with other government agencies, like the Competition Bureau, to address the recent prevalence of false and misleading claims related to COVID-19.
We encourage all distributors of regulated products and consumer products to ensure related product claims are substantiated with appropriate data.
We recognize that administrative response resulting from COVID-19 is happening in real-time. Our team will continue to monitor these developments and provide updates as necessary. If you require any assistance, please reach out to any member of our team.