Updated requirements for COVID-19 drug authorizations: Notice

From: Health Canada

Date published: March 31, 2021

The COVID-19 pandemic posed an immediate and significant risk to the health and safety of Canadians. To address the public health need in Canada, it was necessary to expedite the authorization of drugs and vaccines for COVID-19.

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ISAD IO in effect until September 16, 2021

The Minister of Health-approved interim order to import, sell and advertise drugs during COVID-19 took effect on September 16, 2020. This interim order, known as ISAD IO, provided a temporary emergency authorization for COVID-19 drugs to address the pandemic.

The ISAD IO introduced temporary regulatory tools to expedite the authorization and licensing for importing, selling and advertising COVID-19-related drugs and vaccines without compromising standards for patient safety. Please refer to the Information and application requirements for drugs authorized under the interim order guidance document.

The ISAD IO ends on September 16, 2021.

Amended Food and Drug Regulations replace ISAD IO

The eventual termination of the ISAD IO meant that drugs authorized through the interim order would no longer be legally permitted to be sold in Canada. As well, any drug establishment licence (DEL) issued through the interim order would be automatically cancelled.

To ensure that COVID-19-related drugs authorized under ISAD IO may continue to be imported and sold in Canada, we introduced transition measures.

The review, authorization and oversight of COVID-19 drugs, including new drugs, can now be conducted under the Food and Drug Regulations. Please refer to the Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. The guidance is final, but stakeholders may submit comments for 30 days after posting. Please email comments to hc.hpfb-covid19-dgpsa.sc@canada.ca.

Stakeholders wishing to maintain their DEL issued under the ISAD IO will be required to notify Health Canada of their intention. Otherwise, the DEL will be automatically cancelled, in full or in part, upon expiry of the interim order (September 16, 2021).

Due to the amended Regulations to allow for these new flexibilities, we have had to update our fees. For more information, please refer to the Guidance on evaluation fees for human drugs and disinfectants.

For more information, contact us by email at hc.hpfb-covid19-dgpsa.sc@canada.ca.

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