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Found 10 records similar to COVID-19: Vaccine safety post-market surveillance
This document provides guidance on brand name assessment, inner and outer product labels, and risk management planning.
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.
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.
The only amendment related to post-market regulation is the Minister’s new (continued) authority to impose terms and conditions for a designated COVID-19 drug (C.01.014.21).
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.
On this page you can find vaccine safety, Common side effects, COVID-19 vaccine ingredients, Allergic reactions, rare reactions that have been reported, Ongoing monitoring of side effects and reactions of COVID-19.
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.
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.
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.
Learn more about drugs and vaccines being developed or authorized for COVID-19.