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This section of the guidance outlines the additional requirements for good clinical practices, qualified investigators, and labelling.

Record Modified: Oct 28, 2023
Record Released: Oct 26, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance for applicants seeking authorization drug-clinical-trials conduct COVID-19 drug-clinical-trials the Regulations additional requirements

This section of the guidance outlines the application processes and guidelines under the Regulations.

Record Modified: Oct 28, 2023
Record Released: Oct 26, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance for applicants seeking authorization drug-clinical-trials conduct COVID-19 drug-clinical-trials the Regulations application process

This section of the guidance outlines requirements for the licence holder after authorization of the clinical trials.

Record Modified: Oct 28, 2023
Record Released: Oct 26, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance for applicants seeking authorization drug-clinical-trials conduct COVID-19 drug-clinical-trials the Regulations post-authorization requirements

The purpose of this notice is to advise stakeholders that Health Canada is proposing to: maintain the flexibilities and regulatory …

Record Modified: Oct 28, 2023
Record Released: Oct 26, 2023
Publisher: Health Canada
Formats: HTML
Keywords: ensuring predictability COVID-19 clinical trials proposal for clinical-trials notice to stakeholders

The purpose of this Notice of Amendment is to notify about the addition of casirivimab and imdevimab to the Prescription …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL casirivimab imdevimab human-and-veterinary PDL

The purpose of this Notice of Amendment is to notify about the addition of sotrovimab to the Prescription Drug List …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Sotrovimab (COVID-19)

COVID-19 and other drug product announcements until July 2023.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug product announcements COVID-19 vaccine announcements

General COVID-19 flexibilities for all disinfectant application/submission pathways.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: applying for DIN DIN for disinfectant-drug COVID-19 pandemic application flexibilities COVID-19 flexibilities disinfectant application/submission

Steps to select the applicable fee category, the proper application stream and the pathways used to seek an authorization for …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: applying for DIN DIN for disinfectant-drug COVID-19 pandemic application stream applicable fee category proper application stream authorization for disinfectant-product

This document provides information on the application process and application contents for a disinfectant drug product regulated under the Food …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: applying for DIN DIN for disinfectant-drug COVID-19 pandemic purpose-and-eligible products