COVID-19: New tools to prevent and alleviate drug shortages related to the pandemic

Drug Establishment Licensing Bulletin 98, October 28, 2020

Protecting the supply of certain drugs during the COVID-19 pandemic has been challenging. To reduce the impacts of drug shortages, the Minister of Health signed the Interim Order respecting the prevention and alleviation of shortages of drugs in relation to COVID-19. This interim order (IO) took effect upon signing, on October 16, 2020.

A shortage is considered related to the pandemic if the drug is used to treat COVID-19 patients or its availability has been impacted by the pandemic.

The IO gives the Minister new authorities to:

• require the provision of information and
• place terms and conditions on a market authorization for a drug

Health Canada and drug supply chain stakeholders have collaborated extensively over the past several years to address drug shortages. The COVID-19 pandemic has led to an increase in the number of critical drug shortages occurring in Canada. Multi-stakeholder collaboration has been critical in effectively addressing these shortages.

An IO is one of the fastest mechanisms available to deal with significant health and safety risks, such as large-scale public health emergencies, without following the usual regulatory processes.

Further information on the rationale for this IO can be found in the explanatory note.

Information on the products included in the scope of this IO and the criteria for requiring information or placing terms and conditions are found in a guidance document. You can ask for a copy by emailing hc.prsd-questionsdspr.sc@canada.ca.

Health Canada is holding an information session for stakeholders on Monday, November 2. To participate, please follow one of the following links:

English session: November 2, 2020, 01:00 pm Eastern	French session: November 2, 2020, 02:00 pm Eastern
Join Zoom meeting https://ca01web.zoom.us/j/68861273076 Meeting ID: 688 6127 3076 Passcode: 427223 Dial based on your location +1 647 374 4685 Canada +1 647 375 2970 Canada +1 647 375 2971 Canada +1 778 907 2071 Canada +1 204 272 7920 Canada +1 438 809 7799 Canada +1 587 328 1099 Canada +1 613 209 3054 Canada 1- 855 703 8985 Canada Toll-free	Join Zoom meeting https://ca01web.zoom.us/j/61776816102 Meeting ID: 617 7681 6102 Passcode: 392734 Dial based on your location +1 587 328 1099 Canada +1 613 209 3054 Canada +1 647 374 4685 Canada +1 647 375 2970 Canada +1 647 375 2971 Canada +1 778 907 2071 Canada +1 204 272 7920 Canada +1 438 809 7799 Canada 1-855 703 8985 Canada Toll-free

You may direct your questions or comments to:

Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
200 Eglantine Driveway
Jeanne Mance Building
7th Fl
Tunney's Pasture
Ottawa ON K1A 0K9
Email: hc.prsd-questionsdspr.sc@canada.ca