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Found 10 records similar to Guidance for market authorization requirements for COVID-19 drugs: Labelling and post-market requirements

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

The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not required, sponsors are invited to provide a brand name assessment should one be available.

Last Updated: Jul. 27, 2021
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
Federal

We are collaborating with other national regulatory authorities to align the requirements for evaluating, authorizing and post-market surveillance of variant COVID-19 vaccines as much as possible.

Last Updated: Jul. 28, 2022
Date Published: Mar. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, vaccine manufacturers, requirements for vaccines, SARS-CoV-2 variants
Federal

Canada has several systems in place to monitor the safety and effectiveness of vaccines starting in the early development stage and continuing for as long as the vaccines are in use. Get the facts. Visit Canada.ca/covid-vaccine to learn more.

Last Updated: Aug. 31, 2021
Date Published: Jul. 14, 2021
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  COVID-19, Vaccine safety, post-market surveillance, surveillance, vaccines, vaccine safety, COVID-19 vaccine, vaccine effectiveness, Community immunity
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

This document provides guidance to drug manufacturers seeking authorization for their drug manufactured, sold, or represented for use in relation to COVID-19. The guidance explains recent changes to the regulatory process for new COVID-19 drugs.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process
Federal

COVID-19 drugs must be manufactured under good manufacturing practices (GMP) conditions. These conditions must be in line with the international requirements outlined in the International Council for Harmonization Q7A guideline and with applicable Health Canada's guidance.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process, manufacturing requirements, quality requirements
Federal

This document provides guidance on the standard for accepting a rolling submission and non-clinincal requirements for authorization.

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, rolling submissions, non-clinical-and-clinical requirements
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

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
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