CANADA GAZETTE – Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need)
The objective of the regulatory amendments is to enable access to drugs that would help address an urgent public health need (e.g. opioid use disorder) that have been authorized for sale in either the United States, the European Union, or Switzerland, but are not yet available in Canada.
These Regulations provide an alternate pathway for accessing drugs as a response to an urgent public health need. The use of this alternate pathway is not mandatory, as the existing pathways through the SAP and the filing of a CTA will remain.