Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages)
Date published: September 1st, 2021
The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made on September 1st, 2021. They amend the Food and Drug Regulations and Medical Devices Regulations and are published in Canada Gazette, Part II.
These new regulations extend and modify certain measures already in place through 2 interim orders (IOs). They have been made to help track, 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 much product can be imported and how long it can be sold
- keep the mandatory shortage reporting framework 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 make an amendment to the Certificate of Supplementary Protection Regulations. The definition of “authorization for sale” is being 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.
On this page
- Why we introduced the amendments
- How the amendments will address health product shortages in Canada
- How the amendments are different from previous interim orders
- Contact us
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 devices
- discontinued treatment or use of a therapeutic product where there is no alternative
- drug or 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 worsened 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
Interim Orders (IO) 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 will come into force in a manner that prevents these powers from lapsing when the IOs expire.
Coming into force on November 27, 2021, are provisions 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 in respect of drug shortages
Coming into force on March 1, 2022, are provisions concerning the:
- exceptional importation and sale of drugs, 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 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 will 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 sale 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 sale 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 sale 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 device that may be experiencing a shortage and then make a decision on measures 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
Health Canada will continue to keep and update 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 therapeutic products.
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 will 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 shortages of medical devices 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 (for example, manufacturing, labelling, distributing or importing them) without an establishment licence. This will allow the continued sale of drug-based hand sanitizers while industry comes into compliance with existing requirements for establishment licensing.
How the amendments are different 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 amendments 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:
- Biocides that were already imported under the IO can continue to be sold to retail stores until December 31, 2022. These biocides can be sold at retail level until they expire or until the stock is exhausted
- Foods for a Special Dietary Purpose that were already imported under the IO can continue to be sold until they expire
We will send out additional notices before the regulations come into force on November 27, 2021, and March 1, 2022. These notices will refer to revised guidance for industry.
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