Therapeutic Product Recall and Licence Changes

Summary#

This is a proposed rule, published in the Canada Gazette on April 15, 2023, that would change the Food and Drug Regulations and the Medical Devices Regulations to tighten and clarify how recalls are reported, modernize some establishment‑licence rules, and allow limited exemptions from finished product testing for certain products. The changes are meant to give Health Canada clearer, faster information during recalls and more flexible tools to manage risks and supply.

What it does#

• Makes recall reporting clearer and faster for drugs:

  • companies must notify Health Canada within 24 hours of deciding to recall and give more detailed information within 72 hours; a final report is due within 30 days of completion.
  • extends the reporting rules to active ingredients and to people (e.g. wholesalers or retailers) who may be ordered by the Minister to recall a product.

• Updates medical device recall rules:

  • manufacturers and importers would only have to report company‑initiated recalls that are likely to cause injury (so most low‑risk notifications would no longer be reported), but all recalls must be documented and records kept.
  • manufacturers/importers still must notify Health Canada within 24 hours of deciding to recall and submit a completion report within 30 days.
  • record-keeping rules require retaining recall records for the device’s projected useful life plus 2 years.

• Modernizes establishment‑licence rules:

  • replaces a hard‑coded table of foreign regulators with an online, updatable list (incorporated by reference) so mutual recognition agreements can be reflected more quickly.
  • requires medical device establishment licence (MDEL) applicants and holders to provide and update contact information (including email) and to give any previous company names — updates must be provided within 15 days when information changes.
  • allows the Minister to impose or change terms and conditions on an MDEL (for example, to restrict certain device types or require corrective measures) so compliance can be handled in a targeted way.

• Eases finished product testing in narrow situations:

  • conditionally exempts packagers/importers/distributors from finished product testing for some short‑lived radiopharmaceuticals (useful life ≤ 30 days) and for certain gene therapies and cell therapies, if the company keeps evidence that the product was properly tested and handled.

• Timing: most changes would come into force six months after the regulations are registered; the updates about designated foreign regulators and the testing exemptions would come into force immediately on registration.

Who's affected#

• Manufacturers, importers, distributors, wholesalers and retailers of drugs and medical devices.
• Holders and applicants for a drug establishment licence (DEL) and a medical device establishment licence (MDEL).
• Companies that make or handle short‑lived radiopharmaceuticals, and developers or suppliers of gene and cell therapies.
• Health Canada (will get earlier and more detailed recall information and new tools for targeted oversight).
• Patients who rely on niche, time‑sensitive therapies or medical devices — the rules aim to protect supply and safety.
• It is not always clear how often the Minister will use the power to impose terms and conditions; the text is a proposal and the exact application will depend on future cases.

Why it matters#

• Faster, clearer reporting (the 24‑hour, 72‑hour, and 30‑day timeframes) gives regulators earlier information to protect people’s health.
• Reducing mandatory reporting for low‑risk device notices cuts paperwork and reputational risk for industry while keeping records for oversight.
• Conditional testing exemptions for certain radiopharmaceuticals and cell/gene therapies are intended to avoid delays and help patients get treatments faster without lowering safety expectations (companies must still show evidence of testing and proper handling).
• Allowing targeted terms and conditions on MDELs helps keep safe parts of a business operating while Health Canada addresses specific problems, instead of suspending an entire licence.
• Health Canada’s cost‑benefit summary estimates annualized benefits of $5,817,052 per year (present value $40,856,537 over 10 years) and a net monetized impact of about $39,536,684 (PV) over 10 years, with modest costs for industry and government.
• These are proposed amendments, not law yet. The Canada Gazette notice invited comments for 75 days after publication.