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Found 10 records similar to Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variants

Federal

How Health Canada is addressing clinical trials of drugs and vaccines, its expedited review process and the Special Access Program to find therapies to prevent or treat COVID-19.

Last Updated: Jul. 27, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, vaccines for COVID-19, drugs for COVID-19
Federal

Variant strains of SARS-CoV-2 are emerging that may affect the level of protection provided by currently authorized COVID-19 vaccines. As a result, manufacturers are adapting authorized COVID-19 vaccines to provide protection against infection and disease caused by virus variants.

Last Updated: Jul. 27, 2021
Date Published: Mar. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
Federal

This document provides guidance to vaccine manufacturers seeking authorization for their vaccine that targets the SARS-CoV-2 virus. This guidance applies to applications under the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19.

Last Updated: Jul. 28, 2022
Date Published: Nov. 18, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, vaccine manufacturers, importation, sale and advertising
Federal

What you, and what communities can do to lower the spread of COVID-19 in settings including social services, workplaces, outdoors, community, religious, transport and remote and Indigenous communities.

Last Updated: Sep. 24, 2021
Date Published: Jun. 12, 2020
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  Coronavirus, COVID-19, pandemic, measures, to reduce, COVID-19, COVID
Federal

COVID-19 vaccine ingredients in the Pfizer-BioNTech, Moderna and AstraZeneca vaccines.

Last Updated: May 28, 2021
Date Published: May 7, 2021
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  Covid-19, pandemic, covid vaccine, Pfizer covid vaccine, Pfizer COVID-19 vaccine, Moderna covid vaccine, Moderna COVID-19 vaccine, AstraZeneca covid vaccine, AstraZeneca COVID-19 vaccine
Federal

This document provides guidance on developing the evidence and documentation needed to obtain an authorization and licensing for importing or selling a COVID-19 vaccine in Canada.

Last Updated: Jul. 27, 2021
Date Published: Apr. 6, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
Federal

This document provides guidance on brand name assessment, inner and outer product labels, and risk management planning.

Last Updated: Jul. 28, 2022
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, labelling requirements, post-market requirements
Federal

Currently there are no therapies available for either the prevention or treatment of COVID-19. Health Canada is closely tracking all potential therapeutic treatments and vaccines in development in Canada and abroad, including products that are being used off-label. The Department is working with vaccine developers, researchers, and manufacturers to help expedite the development and availability of medical products such as vaccines, antibodies, and drugs to prevent and treat COVID-19.

Last Updated: Sep. 25, 2020
Date Published: Apr. 2, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Vaccines for COVID-19, treatments for COVID-19, vacc.ine developers, researchers, and manufacturers
Federal

This document provides guidance on establishment licensing, product quality and lot release to bring a COVID-19 vaccine to market in Canada.

Last Updated: Jul. 28, 2022
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, vaccine manufacturers, establishment licensing, product quality
Federal

This report presents evidence-informed recommendations for testing a vaccinated population and vaccinated individuals.

Last Updated: Sep. 24, 2021
Date Published: Sep. 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, testing for COVID-19, testing vaccinated populations, testing vaccinated individuals
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