Drug Establishment License Holders to Import Urgently Needed Drugs

Health Canada’s April 2017 announcement regarding the importation of drugs for urgent public health needs confirmed that the Canadian government is indeed taking steps to respond quickly to a public health crisis. Health Canada plans to achieve this by opening up a new regulatory pathway for importation of products that have not been authorized for sale in Canada, but are approved in the US, The European Union or Switzerland. The proposed amendment to the Food & Drug Regulations will allow licensed facilities to import unapproved drug products to Canada as long as that product is included in the official List of Drugs for an Urgent Public Health Need (the “List”).

Drug establishment license (DEL) holders will be in an advantageous position as they will be allowed to import foreign-authorized medications as long as the license holder complies with some mandatory procedures including the notification to Health Canada within15 days of importation of a drug on the List, and proper record keeping in order to support a potential recall.

This Health Canada initiative was primarily focussed on the current opioid crisis. However if future population-based urgent needs arise in Canada (such as a flu pandemic) a system will now be in place to allow Health Canada to respond quickly and efficiently to the need for unapproved medication for Canadians.

Find out more on the proposed amendments to the Food & Drug Regulations (Importation of Drugs for an Urgent Public Health Need) at: http://www.gazette.gc.ca/rp-pr/p1/2017/2017-04-22/html/reg3-eng.php