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 August 11th, 2021. They amend the Food and Drug Regulations and Medical Devices Regulations and were published in Canada Gazette, Part II on September 1st, 2021.

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:

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.

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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:

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 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:

Coming into force on March 1, 2022, are provisions concerning the:

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:

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:

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:

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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