Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada
From: Health Canada
Current status: Open
Opened on December 28, 2024 and will close on March 8, 2025.
Health Canada is proposing to amend the Food and Drug Regulations and Medical Devices Regulations to help prevent and mitigate the risk of harm to human health due to drug and medical device shortages and discontinuations. The proposed amendments:
- are outlined in the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices)
- were published for consultation in the Canada Gazette, Part I, on December 28, 2024
Key questions for discussion
Your ideas and input are sought around the proposed amendments to the Food and Drug Regulations and Medical Devices Regulations concerning shortages and discontinuations for drugs and medical devices, and the associated draft guides. The regulatory amendments would give Health Canada more tools to help prevent adverse health outcomes due to a drug or medical device shortage.
The input gathered through this consultation process will help us:
- design systems and procedures that promote readiness and a rapid response to shortages
- detect when there's a risk of a shortage and intervene to help avoid the shortage before it happens
- detect early shortage signals to minimize their impacts when they occur and restore access to needed products quickly
Who is the focus of this consultation
We want to hear from:
- drug and medical device industry stakeholders, such as:
- manufacturers
- distributors
- wholesalers and importers
- industry associations
- group purchasing organizations
- health care providers and associations
- researchers and academics
- Indigenous groups and communities
- provincial and territorial governments
- the public, including patients, families and caregivers
Join in: How to participate
Share your ideas online
Use the following table to submit your ideas and comments. Note: Links to the draft guides for consultation are provided at the end of the table.
Proposed regulations and lists incorporated by reference
| Title | Description | How to provide feedback |
|---|---|---|
Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) |
These are the proposed regulatory changes to the Food and Drug Regulations and Medical Devices Regulations. The regulatory impact analysis statement describes the goal of the regulations, proposed implementation and expected impact. |
Submit your comments using the comment boxes provided in the: |
| Lists incorporated by reference - drugs | ||
List of Drugs for the Purposes of the Definition "Drug" in Section C.01.014.8 (Expanded Scope List) |
This is the draft landing page for a proposed new regulatory list to identify non-prescription drugs that would be covered by the shortage requirements, such as for reporting shortages and discontinuations. |
Submit your comments on how the lists are formatted by email to hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca. Indicate the documents you are commenting on. Note: We would be holding a separate consultation on the drugs we propose to add to the Safety Stock List and the Expanded Scope List when the final regulations come into force. |
List of Drugs for the Purposes of Section C.01.014.84 of the Food and Drug Regulations (Safety Stock List) |
This is the draft landing page for a proposed new regulatory list to indicate which drugs require safety stock to be held in Canada. |
|
List of Drugs with Extended Expiration Dates (Extended Expiration Date List) |
This is the draft landing page for a proposed new list to indicate which lots or batches of drugs have an extended expiration date for the purpose of addressing a shortage. |
|
This is the draft landing page for the existing list, which would change with the proposed regulatory amendments. Drugs on this list would be allowed for exceptional importation and sale in Canada. |
||
New draft guidance to support this regulatory proposal
| Title of document | How to provide feedback |
|---|---|
| Drugs | |
Draft for consultation: Guide to shortage prevention and mitigation plans |
Submit your comments by email to hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca. Indicate the documents you are commenting on. |
Draft for consultation: Guide to reporting drug demand surges |
|
Draft for consultation: List of drugs that are critical and vulnerable to shortages (Critical and Vulnerable Drug List) |
Submit your comments via the Consultation on draft Critical and Vulnerable Drug List questionnaire. The questionnaire will be available from January 6th to March 8th 2025. If you would like to receive the questionnaire in another format, email us at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca. |
Proposed updates to existing guidance to support this regulatory proposal
| Title of document | How to provide feedback |
|---|---|
| Drugs | |
Draft for consultation: Guide to reporting drug shortages and discontinuations (GUI-0120) |
Submit your comments by email to hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca. Indicate the documents you are commenting on. |
Medical devices |
|
Draft for consultation: Guide to reporting medical device shortages and discontinuations (GUI-0137) |
Submit your comments by email to hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca. Indicate the documents you are commenting on. |
Draft for consultation: Guide to the exceptional importation and sale of medical devices (GUI-0147) |
|
Participate by mail
Mail your ideas and comments for items that are open for consultation by sending a letter to the address in the Contact us section.
Contact us
Director, Policy and Data Division
Health Product Shortage Directorate
Health Canada
200 Tunney's Pasture Driveway
Ottawa ON K1A 0K9
Email: hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca
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