Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice

Date published: February 26, 2022

About the new regulations

The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made on August 11, 2021. They amend the Food and Drug Regulations and Medical Devices Regulations and were published in Canada Gazette, Part II on September 1, 2021.

These Regulations extend and modify certain measures already in place through 2 interim orders (IOs). They have been made to help monitor, prevent and mitigate shortages of key health products in Canada, including drugs and medical devices.

In particular, the Regulations:

allow the Minister to require certain regulated parties to provide information needed to assess or respond to a drug or medical device shortage
keep the existing framework for the exceptional importation of drugs and medical devices, but with small modifications to clarify how a product may be eligible for the framework, how much product can be imported and how long it can be sold
keep the mandatory shortage reporting framework for specified medical devices and add the reporting of discontinuations for specified medical devices
prohibit the distribution of certain drugs intended for the Canadian market for consumption outside Canada if it could cause or worsen a shortage
end the exceptional importation of biocides and foods for a special dietary purpose and introduce temporary flexibilities to allow the sale of products that were already imported into Canada
continue temporary flexibilities related to drug establishment licensing for activities related to drug-based hand sanitizers

The Regulations also amend the Certificate of Supplementary Protection Regulations. The definition of "authorization for sale" is amended to also exclude exceptional importation for a drug under C.10.008(1). This change is consistent with other exclusions of limited purpose authorizations in these Regulations.

Why we introduced the amendments

Drug and medical device shortages are a growing global problem, especially for small markets like Canada.

Health care providers need to access drugs and medical devices to provide proper and timely treatment.

Drug and medical device shortages can contribute to a number of negative outcomes, like:

adverse patient outcomes, including delayed or cancelled surgeries
disruptions in care because of the need to use other treatments or medical devices
discontinued use of a therapeutic product where there's no alternative
drug or medical device rationing or hoarding

In 2020 and 2021, the Minister of Health made IOs giving Health Canada new powers to respond to shortages caused or made worse by the COVID-19 pandemic. These include:

Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply), made on November 27, 2020
Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose, made on March 1, 2021

These IOs expire 1 year after they are made by the Minister.

These new Regulations were introduced to preserve powers from IOs that are still needed to address future shortages.

The Regulations were scheduled to come into force in a manner that prevents these powers from lapsing when the IOs expire.

On November 28, 2021, provisions came into force that:

prohibit the distribution of drugs intended for the Canadian market outside of Canada that could cause or worsen a shortage
allow the Minister to compel information concerning a drug shortage

On March 2, 2022, provisions coming into force concern the:

exceptional importation and sale of drugs and medical devices
continued sale of exceptionally imported foods for a special dietary purpose as well as biocides for a set period
amendment to the Certificate of Supplementary Protection Regulations
mandatory reporting of shortages and discontinuations of specified medical devices and the power to compel information on medical device shortages
extension of licensing flexibilities for some drug-based hand sanitizers

How the amendments address therapeutic product shortages in Canada

These Regulations prohibit the distribution of certain drugs intended for the Canadian market outside of Canada if that sale could cause or worsen a drug shortage. The prohibition applies to drug establishment licence (DEL) holders (for example, fabricators, wholesalers and distributors). A distribution is only permitted if the DEL holder has reasonable grounds to believe that it will not cause or worsen a drug shortage.

The DEL holder is required to determine whether the distribution could cause or worsen a shortage before distributing the drug for use outside Canada. The DEL holder must then make a record showing how this was determined.

The Regulations do not apply to:

the distribution of drugs for consumption outside of Canada if it will not cause or worsen a drug shortage
drugs manufactured for export (not labelled for the Canadian market)

Under these Regulations, the Minister may require that certain regulated parties provide specific information needed to assess or respond to a drug or medical device shortage. The Minister uses this information to:

assess the level of risk for the drug or medical device that may be experiencing a shortage; and
decide on measures to be taken that may prevent or alleviate the shortage

These Regulations also keep the existing framework for the exceptional importation of drugs and medical devices that:

may not fully meet Canadian regulatory requirements but
are manufactured according to comparable standards

The Regulations incorporate lists of drugs and medical devices that may be temporarily imported and sold on an exceptional basis. This will help prevent and alleviate shortages while maintaining Canada's high quality standards for health products. These lists will be updated as necessary.

The new Regulations also end the exceptional importation of biocides and foods for a special dietary purpose. Temporary flexibilities have been introduced to allow the sale of products that were already imported into Canada through the IOs. The changes give retail sellers the opportunity to sell the existing stock of imported products.

Under the new Regulations, manufacturers and importers of specified medical devices are still required to report shortages of their devices. Health Canada will be able to continue to track these shortages and inform Canadians when there is a shortage or risk of shortage.

These amendments also extend temporary flexibilities allowing some people to conduct activities related to drug-based hand sanitizers without an establishment licence. Examples of activities are manufacturing, labelling, distributing or importing. This allows the continued sale of drug-based hand sanitizers while industry comes into compliance with existing requirements for establishment licensing.

Health Canada developed guidance documents for the new provisions to help industry stakeholders understand their obligations and comply with the new Regulations.

How the amendments differ from previous interim orders

The Regulations are similar to provisions contained in the IOs. Because these IOs have been in place for some time, Health Canada and stakeholders have been able to use the provisions, consult on amendments and identify improvements. Based on this, we made some minor changes to make them clearer and easier to implement. For example, the Regulations clarify how long DEL holders need to keep records or when manufacturers or importers need to submit medical device shortage reports.

The Regulations do not allow for the exceptional importation of biocides and foods for a special dietary purpose, which was permitted by Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose. Exceptional importation of biocides and foods for a special dietary purpose will end when that IO expires on March 1, 2022.

We have introduced temporary flexibilities so that products that were already imported into Canada may continue to be sold. For example, foods for a special dietary purpose that were already imported under the IO can continue to be sold until they expire.

However, Health Canada will delay the end date by which importers of products on the List of biocides for exceptional importation and sale must cease importation. We have based our decision on the current state of the COVID-19 pandemic in Canada and its effect on the supply chain

We are implementing the following measures for designated biocides that were previously accepted to the List of biocides for exceptional importation and sale under the IO:

Exceptional importation of designated biocides will be permitted until September 30, 2022.
Distribution of these products will be permitted to retail facilities until December 31, 2022.
Retail sale and use at the institutional level will be permitted until product in stock has been exhausted or has expired.

Contact us

If you have any questions, please contact us by email at prsd-questionsdspr@hc-sc.gc.ca.

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Date modified:: 2022-09-01

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