Regulatory News

Health Canada’s Interim Order for the import, sale, and advertising of Drugs for use in relation to COVID-19 (ISAD IO) will be in place until September 16, 2021 and then replaced by Amended Food and Drug Regulations.

Thereafter, Drug authorizations under ISAD IO will no longer legally be permitted to be sold in Canada and any DELs issue under this Order will be automatically canceled. DEL holders who intend to maintain their DEL must notify Health Canada. COVID-19-related Drugs will be authorized under the amended Food and Drug Regulations. Consult the updated guidance on the amended Regulations here, which has also resulted in an update in fees.