Drug shortages in Canada: Regulations and guidance
On this page
- About the regulatory provisions for drug shortages
- Mandatory reporting of drug shortages and discontinuations
- Exceptional importation and sale of drugs
- Risk communication plans
- Requirement to provide information on drug shortages
- Prohibition on distributing certain drugs intended for the Canadian market for use outside Canada
- Contact us
About the regulatory provisions for drug shortages
The Food and Drug Regulations (FDR) contain provisions that help to safeguard the Canadian drug supply. The regulatory provisions are one part of Canada's overall multi-stakeholder toolkit to help prevent and mitigate drug shortages. Compliance and enforcement actions related to these provisions are undertaken as per Health Canada's Compliance and enforcement policy for health products (POL-0001).
The regulatory provisions for drug shortages only apply to human drugs that require a prescription or are used only under the supervision of a health care professional. They do not apply to natural health products, veterinary drugs or over-the-counter drugs.
Mandatory reporting of drug shortages and discontinuations
Since March 2017, manufacturers have been mandated to report actual and anticipated drug shortages and discontinuations to the third-party website Drug Shortages Canada.
To help mitigate a shortage, it's critical to have information on an anticipated or actual shortage or discontinuation as early as possible. Mandatory reporting:
- creates greater transparency around shortages and discontinuations
- helps to inform actions throughout the supply chain
- helps the health care system prepare for and respond to gaps in supply
In some cases, drug shortages are resolved and patients don't experience any difficulty obtaining their drugs.
Shortages and discontinuations that must be reported
A shortage is any situation when a drug manufacturer isn't able to fully meet demand for its drug in Canada. There are 2 types of shortages:
- anticipated shortages (if a manufacturer believes a shortage is likely to occur in the future)
- actual shortages (if a manufacturer determines they are currently not able to meet demand)
Manufacturers shouldn't wait until inventory of a drug is in 'stock-out' (that is, is depleted completely) before reporting an actual shortage. They must report all instances in which they cannot meet demand or expect they will not be able to meet demand.
Market authorization holders (MAHs) must report all shortages, no matter how long the shortage will last and even if other options are available to meet demand.
A discontinuation is when an MAH decides to permanently stop selling a drug in Canada.
Manufacturers must report all shortages and discontinuations:
- within 5 calendar days of becoming aware of an anticipated shortage/discontinuation that is expected to happen in the next 6 months
- within 5 calendar days of becoming aware of an actual shortage
Manufacturers must also update all existing shortage and discontinuation reports within 2 calendar days of becoming aware of a change in information (that is, the estimated end date of a shortage).
For further guidance for industry, please refer to our Guide to reporting drug shortages and discontinuations (GUI-0120).
Manufacturers must notify Health Canada of an interruption of the sale of certain drugs when they have not been sold in Canada for 12 consecutive months (drug becomes dormant). They must also notify us on resumption of the sale of a drug following a period of 12 consecutive months without sales.
For more information, please refer to the following guidance document:
Exceptional importation and sale of drugs
The FDR create a framework for the exceptional importation and sale of drugs that are not otherwise licensed for sale in Canada. This framework is intended to help address critical drug shortages such as Tier 3 shortages. These drugs are not fully compliant with Canadian regulations, but are manufactured according to similar standards.
Exceptional importation was initially implemented via interim orders (IOs) in 2020-2022. The last of these was the Second Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19(IO No. 2).
The IO provisions on the exceptional importation and sale of drugs have been transitioned into permanent amendments to the FDR, which came into force on March 2, 2022. The permanent regulations do not require a drug shortage to be related to the COVID-19 pandemic to be eligible for exceptional importation and sale.
To be eligible for the exceptional importation and sale provisions, drugs must be included on the List of drugs for exceptional importation and sale Health Canada maintains and updates the list as required. A drug that has been added to the list is called a "designated drug".
For more information, please consult the following guidance document:
Risk communication plans
Section C.10.011 of the FDR requires risk communication plans to support the safe use of designated drugs. DEL holders are expected to work closely with Health Canada when developing and implementing their risk communication plans.
Health Canada reviews risk communication plan requirements as part of the proposal review process for designated drugs. In most cases, it's expected that DEL holders will generate letters to health care professionals that contain information:
- on the safe use of the designated drug
- comparing the Canadian-authorized product in shortage to the foreign-authorized product
In some cases, Health Canada may take the lead in developing the risk communication plan. Before a designated drug can be sold in Canada, risk communications to support its safe use must be finalized and made available in English and French.
Before drafting a risk communication document (for example, a "dear health care professional" letter), companies should wait for Health Canada to complete its review of the proposal and the risk communication requirements. The review will include recommendations on the information to include in the risk communication plan, such as:
- the audience for risk communications, such as group purchasing organizations (GPOs), wholesalers, health care professional associations and customers
- it may be necessary to indicate specific recipients, such as hospital pharmacists or anesthesiologists
- the method for sending out the information (for example, by fax, posting on the company's website, attaching a copy of customer letter with each shipped unit)
- a statement that Health Canada has permitted the exceptional, temporary importation and sale of the foreign-authorized product
- information to support safe use of the designated drug, including:
- name of the foreign product and the reason it's being imported
- differences between the foreign and Canadian products that are relevant to users (for example, approved indications, expression of strength, packaging, volume, concentration, storage conditions)
- specific recommendations to health care professionals about the appropriate use of the foreign product (for example, use during pregnancy)
Recommendations will also include the following:
- where to find information about the Canadian-authorized and foreign products online
- how to report adverse reactions
- English and/or French translation of the foreign product label(s), if the original label does not include both languages
- a clear image of the foreign product label(s) as well as the final foreign product in its primary packaging
Requirement to provide information on drug shortages
Obtaining information as quickly as possible is an important step in mitigating or preventing drug shortages. Health Canada continues to rely on strong stakeholder relationships and the voluntary sharing of information on actual and anticipated shortages. Regulatory requirements have been put in place to encourage companies to provide information in a timely manner.
The Minister of Health made the Interim Order respecting drug shortages (safeguarding the drug supply) on November 27, 2020. This interim order allowed Health Canada to compel a MAH or drug establishment licence (DEL) holder to provide information on actual or anticipated drug shortages. The provisions have been transitioned to permanent provisions in the FDR, which took effect on November 28, 2021.
For the requirements to provide information, please refer to the following guidance document:
Prohibition on distributing certain drugs intended for the Canadian market for use outside Canada
A DEL holder who plans to distribute a drug intended for the Canadian market for consumption or use outside of Canada must prove that doing so will not cause or worsen a drug shortage within Canada. The regulatory provisions for such an assessment were first introduced in the Interim Order respecting drug shortages (safeguarding the drug supply) on November 27, 2020. The provisions have been transitioned to permanent provisions in the FDR, which took effect on November 28, 2021.
For the requirements on distributing Canadian drugs for use outside Canada, please refer to the following guidance document:
Contact us
Drug Shortages Division: Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca
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