Drug shortages in Canada: Regulations and guidance

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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:

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:

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:

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:

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:

Recommendations will also include the following:

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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