Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada
From: Health Canada
Current status: Closed
Opened from December 28, 2024 to March 8, 2025.
Health Canada has proposed 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:
- were 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
Who was the focus of this consultation
We wanted 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
Key questions for discussion
Your ideas and input were 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 documents for consultation included:
1) Proposed regulations and lists incorporated by reference
- Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) and the associated Regulatory Impact Assessment Statement
- List of Drugs for the Purposes of the Definition "Drug" in Section C.01.014.8 (Expanded Scope List)
- List of Drugs for the Purposes of Section C.01.014.84 of the Food and Drug Regulations (Safety Stock List)
- List of Drugs with Extended Expiration Dates (Extended Expiration Date List)
- List of Drugs for Exceptional Importation and Sale
2) New draft guidance to support the regulatory proposal
- Draft for consultation: Guide to shortage prevention and mitigation plans
- Draft for consultation: Guide to reporting drug demand surges
- Draft for consultation: Guide on extending expiration dates of marketed drugs in response to drug shortages
- Draft for consultation: Guide to safety stocks
- Draft for consultation: List of drugs that are critical and vulnerable to shortages (Critical and Vulnerable Drug List)
3) Proposed updates to existing guidance to support the regulatory proposal
Drugs
- Draft for consultation: Guide to reporting drug shortages and discontinuations (GUI-0120)
- Draft for consultation: Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145)
- Draft for consultation: Guide on the requirements for providing information related to drug shortages (GUI-0146)
- Draft for consultation: Guide on the exceptional importation and sale of drugs in response to drug shortages and discontinuations (GUI-0148)
Medical devices
- Draft for consultation: Guide to reporting medical device shortages and discontinuations (GUI-0137)
- Draft for consultation: Guide to the exceptional importation and sale of medical devices (GUI-0147)
The input gathered through this consultation process was intended to 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
We will review the feedback and makes changes as necessary. The final regulations will be published in Part II of the Canada Gazette.
Contact us
Director, Policy and Data Division
Health Product Shortages Directorate
Health Canada
200 Tunney's Pasture Driveway
Ottawa ON K1A 0K9
Email: hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca