Open Government Portal

46954 records

When Health Canada issues certain negative decisions related to the submission review process for a human drug, including hard-surface disinfectants, …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: human drug submissions natural health products submission review process reconsideration of decisions

To provide sponsors of an Abbreviated New Drug Submission or an Abbreviated Extraordinary Use New Drug Submission who are seeking …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: New-Drug-Submission Abbreviated New-Drug Submission Abbreviated Extraordinary-Use New-Drug-Submission pharmaceutical equivalence bioequivalence reference drug Canadian reference product CRP foreign-sourced reference product

The purpose of the guidance document is to outline the requirements when preparing submissions that rely on Certificates of Suitability …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Drug-Submissions certificates-of-suitability use of certificates-of-suitability supporting-information in Drug-Submissions safety-and-effectiveness of drug

For Drug Identification Number applications, a separate completed HC/SC 3011 must be provided for each formulation, strength and dosage form. …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance completing Drug-Submission-Application Form DIN applications formulation form strength-and-dosage form

Health Canada has recently updated the Guidance document on fees for the review of human and disinfectant drug submissions and …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug submissions-and-applications human-drugs-and-disinfectants submission guidance-document on fees fees for review evaluation fees guidance-document overview revised guidance

The applicable fees are laid out in Schedule 1 of the Fees in Respect of Drugs and Medical Devices Order. …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug submissions-and-applications human-drugs-and-disinfectants submission guidance-document on fees fees for review evaluation fees applicable-fees and fee-groupings revised guidance

The DPR lays out CSC's performance during the fiscal year against the plans, priorities and expected results set out in …

Record Modified: Aug 27, 2023
Record Released: Aug 25, 2023
Publisher: Correctional Service of Canada
Formats: HTML
Keywords: Report departmental results rehabilitate Report on Plans and Priorities

Appearance by the Deputy Minister of Employment and social Development Canada, François Tremblay, at the Standing Committee on Public Accounts …

Record Modified: Aug 27, 2023
Record Released: Aug 25, 2023
Publisher: Employment and Social Development Canada
Formats: HTML
Keywords: ESDC PACP committee binder proactive disclosure deputy minister françois tremblay appearance reports auditor general parliament report 10 ...

This fact sheet presents information on criminal court cases where the most serious offence in the case is a drug-related …

Record Modified: Aug 27, 2023
Record Released: Aug 25, 2023
Publisher: Department of Justice Canada
Formats: HTML PDF
Keywords: Drugs Mandatory Minimum Penalty Criminal Justice Justice System

Astronomical data from the Massive Compact Halo Objects MACHO product held in the Canadian Astronomy Data Centre (CADC).

Record Modified: Aug 25, 2023
Record Released: Nov 25, 2016
Publisher: National Research Council Canada
Formats: HTML
Keywords: Canadian Astronomy Data Centre CADC observatory telescope MACHO Magellanic Cloud Milky Way dark matter