Remdesivir (Veklury): Authorization information

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• Notice of compliance with conditions
• Risk management plan
• International considerations

Notice of compliance with conditions

Health Canada approved remdesivir with conditions to ensure the continued safety, efficacy and quality of the drug. Following submission by the manufacturer for approval, we issued a notice of compliance (NOC) as per the Food and Drug Regulations, under the notice of compliance with conditions guidance.

Find detailed technical information about remdesivir, such as the product monograph and our regulatory decision summary, in the COVID-19 vaccines and treatments regulatory portal.

An NOC with conditions supports early access to promising medicines where there’s an unmet medical need. Health Canada issues a market authorization with conditions when we’ve approved a medicine on the basis of less comprehensive data than would normally be required.

The drug must show promising evidence that it works well, is of high quality and is reasonably safe. The available data must demonstrate that the medicine’s benefits outweigh its risks.

Based on its review, Health Canada authorized remdesivir with conditions. As a result, the manufacturer (Gilead Sciences Canada, Inc.) is required to submit to Health Canada:

• post-market safety monitoring reports, such as those on serious adverse drug reactions, and foreign regulatory actions related to the drug’s safety
• any further data on the safety and efficacy of the drug, including final data from ongoing clinical trials
• further quality data confirming that the manufacturing processes and controls will consistently produce product of suitable quality for the intended use

For more information about the conditions, please see the Qualifying Notice.

Risk management plan

Companies are required to submit a risk management plan (RMP) to Health Canada when applying for a marketing authorization.

RMPs include information on:

• a medicine's safety profile
• how its risks will be prevented or minimized in patients
• plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine
• measuring the effectiveness of measures that minimize risk

Health Canada reviewed the RMP for remdesivir and found it to be acceptable.

International considerations

Health Canada exchanges information with our international regulatory counterparts on an ongoing basis to support the review process and post-market safety monitoring activities.

Health Canada is aware of the World Health Organization’s updated guidelines for the use of remdesivir. 

At this time, Health Canada is not making any immediate changes to the status of remdesivir in Canada. Remdesivir will continue to be available as a treatment option for those with severe COVID-19 disease.

We will continue to actively monitor and review all relevant data to determine whether changes to the market authorization of remdesivir in Canada are required.

Related links

• Notice prescription drug list for remdesivir
• Remdesivir regulatory authorization information
• Update on remdesivir: continued monitoring
• Importation of U.S. clinical trial-labelled remdesivir for injection due to shortage of Canadian-labelled remdesivir
• List of authorized drugs, vaccines and expanded indications for COVID-19
• Vaccines and treatments for COVID-19