Draft for consultation: Guide to shortage prevention and mitigation plans
This page is for consultation purposes only and may change. Learn about the consultation and how to provide your feedback. The consultation closes on March 8, 2025.
Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.
On this page
- Overview
- Responsibilities of regulated parties and Health Canada
- Understanding the regulations
- Providing an SPMP to Health Canada on request
- Definitions
- Resources
- Contact us
Overview
Introduction
Health Canada is responsible for helping people in Canada maintain and improve their health. This is done, in part, through our commitment and actions to help address and mitigate the harm to public health caused by drug shortages. Our goal is to help ensure that people in Canada have access to the drugs they need when they need them.
Market authorization holders (MAHs) are required to have shortage prevention and mitigation plans for their drugs for which a shortage could present a serious risk of injury to human health. This requirement is laid out in section C.01.014.81 of the Food and Drug Regulations (FDR).
MAHs are well placed to assess and address potential shortage risks. Health Canada has established criteria to help determine if a shortage of that drug could present a serious risk of injury to human health. Drugs on the Critical and Vulnerable Drug List (CVDL) meet this criteria and this list is publicly available.
Learn more about drug shortages and the roles of various stakeholders in addressing them.
Purpose
This guidance document will help MAHs understand how to comply with the regulations for developing and maintaining drug shortage prevention and mitigation plans (SPMPs). It outlines the:
- circumstances in which MAHs are required to establish and maintain an SPMP
- information that should be included in an SPMP
- record keeping requirements related to SPMPs
Scope
Inclusions
Section C.01.014.81 of the FDR applies to the following drugs for which a shortage could present a serious risk of injury to human health:
- drugs listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances Act
- drugs on the Prescription Drug List
- drugs listed in Schedules C and D of the Food and Drugs Act (FDA)
- known as radiopharmaceuticals and biological drugs
- drugs that may be sold without a prescription, but are administered only under a practitioner's supervision
- commonly referred to as "ethical" drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents)
- drugs that are set out in Part 1 and 2 of the List of Drugs for the Purposes of the Definition "Drug" in Section C.01.014.8 (Expanded Scope List) which is:
- incorporated by reference into the FDR
- updated as required
Health Canada interprets a serious risk of injury to human health due to a shortage as the likelihood that interruption, lack or delay of treatment due to a shortage could cause serious harm to human health.
Elements that determine the seriousness of the harm caused by interruption, lack or delay in treatment due to a shortage include, but are not limited to, an injury that:
- results in death
- is life threatening
- requires inpatient hospitalization or prolongs existing hospitalization
- results in persistent or significant disability/incapacity
As an MAH, you must determine if a shortage of your drug could present a serious risk of injury to human health. The CVDL contains drugs for which a shortage could present a serious risk of injury to human health. Use this list to help you determine if SPMPs are required for the drug that you manufacture.
Learn more about how we develop the list of drugs for which a shortage could present a serious risk of injury to human health:
Exclusions
The following products are excluded from the scope of these provisions:
- natural health products
- drugs that have a Drug Identification Number (DIN) but do not meet the criteria for inclusion (for example, products like topical antibiotics for cuts and scrapes)
Sex- and gender-based analysis plus (SGBA Plus): Advancing equity, diversity and inclusion
Health Canada has a formal, corporate commitment to applying a sex- and gender-based analysis plus (SGBA Plus) approach to develop, implement and evaluate our activities. This includes our research, surveillance, legislation, policies, regulations, programs and services. This is in keeping with the federal government's commitment to gender-based analysis plus (GBA Plus).
The SGBA Plus process is an intersectional approach to assess how a range of factors interact and intersect with each other and broader systems of power. Examples of factors are sex, gender, age, race, ethnicity, socioeconomic status, disability, sexual orientation, cultural background, migration status and geographic location.
Conducting this analysis helps us to understand how intersecting identity factors, histories, power relations, distribution of resources and individuals' lived realities contribute to differences in accessing health-related resources and health outcomes. By applying SGBA Plus, we can engage in responsive and inclusive health research and develop policies, services, programs and other initiatives to promote greater health equity.
When engaging in this regulatory framework, we encourage you to conduct an SGBA Plus analysis and also take necessary steps to mitigate any possible negative impacts on particular groups.
Learn more about SGBA Plus analysis and assessment:
- Sex- and gender-based analysis plus
- Health portfolio sex and gender-based analysis policy
- Take the gender-based analysis plus course
Note about guidance documents in general
Guidance documents provide assistance to industry on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that Health Canada may consider alternative approaches to meeting the regulatory requirements that stakeholders may propose. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. Stakeholders should discuss their proposals with Health Canada in advance so that the regulator can determine whether the applicable statutory or regulatory requirements can be met.
In accordance with its regulatory authorities and its mandate under the Food and Drugs Act, Health Canada may request other information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with the relevant sections of the regulations and other applicable guidance documents.
Responsibilities of regulated parties and Health Canada
The regulatory requirements in section C.01.014.81 of the FDR applies to MAHs. Health Canada recommends that drug establishment licence (DEL) holders involved in the supply chain for drugs for which a shortage could present a serious risk of injury to human health also establish and maintain SPMPs. DEL holders may follow the procedures outlined for MAHs.
Responsibilities of MAHs
MAHs are responsible for:
- establishing and maintaining an SPMP for any of their drugs for which a shortage could present a serious risk of injury to human health while it's authorized and sold in Canada
- submitting the SPMP for each drug upon request to the Minister within 24 hours or any longer period specified as per subsection C.01.014.81(2) of the regulations
- updating the plan every 3 years or sooner if there is a significant change in the likelihood that a shortage could occur as per subsection C.01.014.81(3)
Note: MAHs must establish and maintain an SPMP for each drug for which a shortage could present a serious risk of injury to human health. The CVDL contains drugs that meet this threshold, but it is not exhaustive, so MAHs may need to determine the risks presented by a shortage of other drugs that are not included on this list.
As well, drugs with comparable risk profiles may be grouped into the same SPMP. For example, drugs with the same active ingredient, route of administration and dosage form with a different strength may have a similar risk profile.
Responsibilities of Health Canada
Health Canada is responsible for:
- providing guidance to MAHs so they can meet the regulatory requirements for SPMPs
- includes consulting with industry on the contents of the guidance
- developing and maintaining the CVDL
- for information on how a drug is added or removed from the list and stakeholder input into the process, visit the CVDL web page
- requesting and reviewing SPMPs
Health Canada conducts compliance and enforcement activities related to these regulatory requirements as per our Compliance and enforcement policy for health products (POL-0001).
Understanding the regulations
Shortage prevention and mitigation plans
As per section C.01.014.81 of the FDR, MAHs must establish and maintain SPMPs for any drugs for which a shortage could present a serious risk of injury to human health.
Health Canada can request that MAHs submit their SPMPs within 24 hours, as needed, or any longer period specified.
To help you develop an SPMP, you should consult:
- ICH Q9 framework
- ISPE Drugs shortages prevention model
This guidance document is aligned with these international frameworks.
Required elements of an SPMP
SPMPs must include a detailed description of the following key elements:
- the measures that you intend to take to identify and assess shortage risks associated with the drug
- the shortage risks associated with the drug you have identified and assessed
- the measures that you intend to take to prevent or mitigate shortage risks associated with the drug
- the measures that you intend to take to mitigate the impacts of a shortage of the drug
- a general description of how you intend to evaluate the effectiveness of the measures you have taken
- how you will communicate to the Minister any significant increase in the likelihood that a shortage of the drug could occur
If applicable, you must also provide a detailed description of the measures to be taken to comply with the obligation in paragraph C.01.014.84(1)(d) of the FDR to maintain a safety stock.
Note: Safety stock requirements apply to drugs for which a shortage could present a serious and imminent risk of injury to human health. These drugs are provided on the List of Drugs for the Purposes of Section C.01.014.84 of the FDR (Safety Stock List).
For more information on maintaining a safety stock, consult:
If you have more than one drug for which a shortage could present a serious risk of injury to human health, you may group drugs with comparable risk profiles in the same SPMP.
Acceptability of SPMPs from other jurisdictions
The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have required formats for shortage prevention plans and risk management plans. These formats generally align with Canada's requirements for SPMPs. Health Canada will generally accept plans from other jurisdictions as long as they include all the specified Canadian elements.
Although the EMA's shortage prevention plans and FDA's risk management plans are in a format that Health Canada accepts, regional differences can affect a drug's shortage risks. Key elements of an SPMP that are specific to Canada may be added to these internationally recognized plans as an annex.
Identifying and assessing shortage risks
MAHs are required to identify and assess the shortage risks associated with their drugs.
When assessing shortage risks, there are many factors to take into consideration. Table 1 gives some examples of risk factors to consider, such as:
- manufacturing process and product issues
- product demand
- distribution issues
- communication issues
For more information on these risks, consult the following International Society for Pharmaceutical Engineering (ISPE) resources:
- Business continuity planning to prevent drug shortages
- Drug shortages prevention model
Risk factor | Explanation |
---|---|
You are the sole MAH or you have a significant market share in Canada. | Shortages of drugs with few alternatives are more likely to have a negative impact on patients or the health system. |
You do not have multiple suppliers for active pharmaceutical ingredients (APIs), bulk process intermediates (BPIs) and finished dosage forms (FDFs) or raw materials. | Sourcing APIs, BPIs, FDFs or raw materials from 1 site makes supply more vulnerable to disruptions (such as natural disasters, geopolitical issues, good manufacturing practices (GMP) compliance issues or manufacturing disruptions). The situation is more pronounced if multiple MAHs are sourcing their API or FDF from the same manufacturing site. |
Your active ingredient or FDF providers have a history of:
|
Active ingredient or FDF providers with a poor record of meeting the requirements may be more vulnerable to experiencing future delays. |
Your manufacturing process requires raw materials or packaging components for which there are limited suppliers or sourcing difficulties. | Packaging shortages can result in production delays. |
Your drug has a low sales volume or a limited shelf life. | It may be difficult to always have adequate inventory levels on hand due to product loss. |
Your manufacturing plant is operating at capacity. | Manufacturing plants operating at capacity have more difficulty meeting an unexpected demand increase or handling issues such as batch rejections. |
There are environmental or geographic risks or other risks associated with your drug supply chains (for example, potential for natural disasters, political instability, competitive landscape, market demand, cyberattacks). | Environmental and geographic events can make raw materials unavailable, concentrate supply chain activities in 1 geographic area or disrupt manufacturing and distribution. These can all contribute to drug shortages. |
Your drug is susceptible to unanticipated increases or fluctuations in demand. | Unstable demand may result in insufficient quantities to meet needs. Also, competitors with a history of going into shortages may lead to increased demand for your drug. |
Your drug has a history of shortage in Canada or other global markets. | A drug with a previous history of shortage may have a higher chance of subsequent shortages. Shortages in more than one country at the same time can lead to increased competition, making it hard for Canada to access the drugs needed to protect public health. |
There are societal or epidemiological trends or emerging needs that could impact demand for your drug. | Certain trends may change demand patterns or have an impact on supply availability. |
The level of inventory maintained in Canada can be a factor. | Drugs with higher in-country inventory levels are usually less at risk of shortage due to unexpected events such as shipping delays or manufacturing issues. |
You encounter logistical challenges (for example, complex supply chain, import or export issues, insufficient reserve inventory or distribution channels). | Logistical challenges can cause drug shortages. |
Your drugs are personalized. | Personalized medicines are more likely to go into shortage due to complex manufacturing processes, specialized components, inability to hold safety stock of finished products and small patient populations. |
You do not have established procedures to communicate with supply chain stakeholders and health care partners as needed. | Lack of sufficient and timely communication between stakeholders may impact distribution and thus contribute to shortages. Robust communication protocols and procedures can help prevent and mitigate shortages. |
Health Canada has identified your drug product as critical and vulnerable to shortage. | The CVDL contains drugs for which a shortage could present a serious risk of injury to human health. This list, developed through a multi-stakeholder approach, serves as guidance for which drugs require a SPMP. This list takes into account the vulnerability of drugs to shortage. |
Shortage management measures
For drugs for which a shortage could present a serious risk of injury to human health, you are required to describe the measures that you intend to take to prevent or mitigate the risk and impacts of a shortage. You are also required to describe how you plan to evaluate the effectiveness of these measures.
Examples of measures you can take to prevent or mitigate the risk of a shortage include having:
- a safety stock or increased inventory levels
- alternative manufacturing sites for critical raw materials
- qualification of alternate API manufacturing sites
- qualification of secondary manufacturing sites
Examples of measures you can take to mitigate the impacts of a shortage include having specific processes in place to:
- communicate availability issues within the company
- communicate availability issues within the supply chain
- report a shortage to Health Canada as per the requirements in subsection C.01.014.9 (1)
As an MAH, you are required to:
- describe how you plan to evaluate the effectiveness of these measures
- have a strategy for communicating to the Minister any significant increase in the likelihood that a shortage of the drug could occur
Health Canada recommends that you also review and amend your SPMPs if the evaluation determined that the shortage management measures were not effective.
Providing an SPMP to Health Canada on request
Health Canada has the regulatory authority as per subsection C.01.014.81(2) to request a copy of an SPMP. You must submit the SPMP to us within 24 hours after we make the request or within any longer period we specify.
During our review of an SPMP, we may verify that all:
- applicable risk factors have been considered
- mitigation and evaluation measures have been identified and
- risk factors have been documented in full
We may also suggest improvements or modifications.
Record keeping requirements
SPMPs must be:
- maintained as long as the drug is marketed and sold in Canada
- updated every 3 years or, if applicable, after a significant change in the likelihood that a shortage of the drug could occur and then every 3 years after the change as per subsection C.01.014.81(3)
- examples of significant changes could include a shortage or consolidation of the supply chain
Definitions
- Active ingredient:
- A drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect.
- Active pharmaceutical ingredient (API):
- An active ingredient that is used in the fabrication of a pharmaceutical.
- Bulk process intermediate (BPI):
- An active ingredient that is used in the fabrication of either a drug of biological origin that is listed in Schedule C to the Act or a drug that is listed in Schedule D to the Act.
- Drug establishment licence (DEL):
- A licence issued to a person in Canada pursuant to Division 1A of the FDR to conduct licensable activities in a building that has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the FDR.
- Drug identification number (DIN):
-
A computer-generated 8-digit number assigned by Health Canada to a drug upon market authorization under subsection C.01.014.2(1) of the FDR.
This number uniquely identifies each drug under the regulations that is sold in a dosage form in Canada. It is located on the package label of prescription and non-prescription drugs that have been evaluated and authorized for sale in Canada.
A DIN uniquely identifies the following characteristics:
- product name
- manufacturer name
- active ingredient or ingredients
- strength of active ingredient or ingredients
- dosage form
- route or routes of administration
- species (for veterinary drugs only)
- Manufacturer or distributor:
- A person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug. (FDR, A.01.010)
- Market authorization holder (MAH):
- Refer to manufacturer or distributor definition.
- Person:
- An individual or an organization as defined in section 2 of the Criminal Code.
- Shortage:
- In respect of a drug, a situation where the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the DIN assigned for the drug is unable to meet the demand for the drug in Canada. (FDR, C.01.014.8 (2))
- Shortage prevention and mitigation plans (SPMPs):
- Plans that aim to prevent the occurrence or mitigate the impact of drug shortages by identifying, assessing and taking measures to prevent or mitigate the shortage risks associated with a drug.
Resources
Legislation and regulations
Policies and guides
Web pages and associated documents
- Drug Shortages Canada
- Drug shortages in Canada
- Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028
Contact us
Contact the Health Product Shortages Directorate by email at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.
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