Health Canada

This labelling standard describes the requirements necessary to receive marketing authorization (Drug identification number (DIN)) for oral expectorant nonprescription product containing guaifenesin as a single ingredient for use in adults and children 12 years of age and older to relieve...

This labelling standard describes the requirements necessary to receive market authorization (a Drug Identification Number (DIN)) for non-prescription oral antitussive products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient for use in adults and children 12...

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.

Decisions made about COVID-19 vaccines will follow processes established for reviews under the modified requirements for COVID-19 drugs. Health Canada will start rolling reviews to build towards a complete dossier for each vaccine. The dossier will include data to support the safety, efficacy and...

Due to the urgent public health needs relating to COVID-19, we can issue a market authorization with conditions. This is done to support early access to promising health products when the potential benefits outweigh the potential risks.

At the time of authorization, no major safety concerns have been reported in the available data submitted to Health Canada. We are carefully monitoring the post-market (after authorization) safety and effectiveness of authorized COVID-19 vaccines. As part of our commitment to keep Canadians...

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...

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.

Modified requirements for COVID-19 drugs allow for the filing of rolling submissions (section C.08.002(2.3) of Canada's Food and Drug Regulations). Before filing a submission for a rolling review, sponsors of clinical trials are expected to have gathered a certain level of evidence on the safety,...

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.