Snapshot

The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. pathway has been developed by the Health Canada of Canada.

This pathway can be used where The Interim Order allows for the issuance of an expedited authorization for the importation, sale and advertising of drugs used in relation to COVID-19; this includes both human and veterinary drugs. It allows the Minister to account for urgent public health needs relating to COVID-19 in deciding whether to authorize a COVID-19 drug based on the provided evidence of safety, efficacy, and quality. The Interim Order also allows establishment licences to be issued in relation to COVID-19 drugs in a more agile manner, taking into consideration urgent public health needs, and provides a mechanism for the Minister to allow the Public Health Agency of Canada (PHAC) to import promising COVID-19 drugs for placement (pre-positioning) in Canadian facilities prior to their authorization in Canada. Applicants can apply for authorization, or they can apply for authorization based on comparison to a foreign drug. Application based on comparison: A person may submit an application for an authorization in respect of a COVID-19 drug under this section on the basis of a direct or indirect comparison to another drug only if the person notifies the Minister of their intention to submit the application and provides information to the Minister to establish that the following requirements are met: a notice of compliance or authorization is issued in respect of the other drug, and the other drug is not offered for sale in Canada or is offered for sale in Canada but not in sufficient quantities to address the urgent public health need related to COVID-19; the Minister, after receiving the notification and information referred to in paragraph (a), provides the manufacturer of the other drug with, having regard to the urgent public health need related to COVID-19, an opportunity to make representations to the Minister as to whether the requirement set out in subparagraph (a)(ii) is met; and the Minister determines that the requirements set out in subparagraphs (a)(i) and (ii) are met and notifies the person in writing of that determination..

It is an abridged review (a reliance pathway).

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