UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with permanent regulatory tools to help prevent or alleviate therapeutic product shortages when the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 and Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) cease to have effect (as reported here).
Health Canada has again released a flurry of COVID-19 related materials. Below are some highlights:
- In response to a new U.S. rule permitting import of certain drugs from Canada, on November 27, 2020, Health Canada issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) prohibiting bulk exportation of drugs which may risk drug shortages. The Interim Order includes, but is not limited to, drugs authorized pursuant to the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (signed September 16, 2020). See our article here.
- Since the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 ends on September 16, 2021, Health Canada recently launched a consultation (closing December 21, 2020) on transition measures and proposed amendments to the Food and Drug Regulations to minimize disruptions when this Interim Order ends. On December 9, Health Canada granted an authorization under this Interim Order for the Pfizer-BioNTech COVID-19 Vaccine. A further three vaccine applications are pending. See our update and original article here.
- Similarly with medical devices, Health Canada announced on November 27, 2020 its intention to maintain the flexibilities provided by the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 when it ends March 18, 2021 by issuing a second Interim Order (for March 2021 to Fall 2021) and then transition regulations for Fall 2021 that would last two years. See November 27, 2020 Notice, including for consultation information. See our original article here.
- Health Canada published new Guidance for market authorization requirements for COVID-19 vaccines (effective November 20, 2020).
- The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 is scheduled to end May 23, 2021. Since the pandemic is continuing, to ensure predictability for COVID-19 trials, Health Canada announced on December 10, 2020 its intention to maintain the flexibilities provided by this Interim Order until at least the fall of 2021 and, through regulatory amendments, beyond. Also proposed are 15-year record retention requirements for clinical trials (whether authorized through the Interim Order or normal regulatory pathway). Health Canada is accepting feedback until January 25, 2021. See our original article here and Health Canada’s December 10, 2020 update here.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.