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

A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph describes the properties, claims, indications and conditions of use for the drug. It also contains any other information that may be required for optimal, safe and effective use of the drug.

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, labelling requirements, post-market requirements
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

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 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
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

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

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

Last Updated: Jul. 29, 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
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