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Open Data Portal Catalogue Dataset
Found 38944 records

Listing of therapeutic products with paediatric information available in their labelling

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: listing of therapeutic-products paediatric information labelling

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: M3(R2) Questions-and-Answers (R2) guidance nonclinical safety studies human clinical trials marketing authorization pharmaceuticals ICH Expert Working-Group regulatory parties

Responding to the Opioid Crisis and Other Emergency Situations.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: urgently needed drugs making available emergency situations opioid crisis responding to opioid-crisis

Medical batteries are medical devices and are regulated under the Food and Drugs Act and Medical Devices Regulations. The Act and Regulations govern the import, advertising and sale of medical devices in Canada.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical batteries medical devices Food-and-Drugs Act Medical Devices Regulations import advertising sale of medical-devices

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical device medical device reports medical device publications medical instruments treatment mitigation diagnosis prevention of a disease abnormal physical condition

Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device licences in Canada now participate in the program, which improves Health Canada's oversight of the medical devices sold in Canada, and ensures that the medical devices Canadians use meet higher quality standards.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical-device medical-device single-audit program MDSAP manufacturers medical-device licences medical-devices sold in-Canada higher quality standards

A growing number of Canadians are using medical test kits in their homes to diagnose or monitor certain health conditions. These test kits are considered to be medical devices. Like all medical devices, they provide potential benefits, but they can also present risks.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical test-kits home use diagnose certain health-conditions medical devices potential benefits present risks

This guidance document provides medical device stakeholders with information on the requirements that the Therapeutics Products Directorate will use in recognizing Auditing Organizations under the MDSAP.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice guidance document requirements recognition process medical-device single-audit program MDSAP auditing organizations medical-device stakeholders

This guidance document applies to drugs regulated under Part C, Division 1 of the Regulations that have received a DIN pursuant to Section C.01.014.2. This includes pharmaceuticals for human and veterinary use, as well as disinfectant drugs, but excludes biologics and radiopharmaceuticals and any drug that has received an NOC.

Last Updated: Dec 1, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice guidance post-drug identification-number DIN changes drugs regulated under-part-C

Since 2016, under Guide BB of the Filing Manual, major CER-regulated pipeline companies are required to report their pipelines’ throughput and capacity data at key points every quarter. Oil and liquids pipelines report monthly data and natural gas pipelines report daily data. This dataset can be explored in interactive dashboard format: A look at pipeline flow and capacity. Throughput and capacity graphs can also be explored by individual pipeline in Pipeline Profiles. The dataset covers 2006 to present. Files are updated quarterly but may be refreshed as needed.

Last Updated: Dec 1, 2023
Date Published: Apr 21, 2017
Publisher: Canada Energy Regulator
Formats: CSV
Keywords: throughput capacity transportation natural gas Canadian oil light heavy refined petroleum products utilization export import ...