Open Government Portal

Open Data Portal Catalogue Dataset
Found 20922 records

Opioid products need to include specific content within their RMP to address: the risk and uncertainties of opioid-related harms in …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: risk management plans RMP submitting RMP risks uncertainties of drug-products procedures to submit opioid products

The RMP summary should include specific sections, which mirror the EU RMP Summary format sections.

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: risk management plans RMP submitting RMP risks uncertainties of drug-products procedures to submit RMP summary template

A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and measures that the manufacturer …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: risk management plans RMP submitting RMP risks uncertainties of drug-products procedures to submit Canadian-specific addendum template

Each year, Health Canada receives thousands of reports of suspected adverse reactions (side effects) about drugs and natural health products …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Adverse reactions medical device incidents health product recalls adverse reaction reports recalls in Canada 2019 summary report Canada Vigilance Program post-market monitoring health product safety

To ensure that advertising material meets Canadian regulatory standards for advertisements for drugs and medical devices, advertising preclearance agencies (APAs) …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: advertising preclearance system preclearance services advertising material regulatory standards advertisements for drugs-and-medical devices advertising preclearance agencies

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Health product infowatch September 2023 pharmaceuticals biologics medical devices natural health products

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Health product infowatch October 2023 pharmaceuticals biologics medical devices natural health products

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Health product infowatch November 2023 pharmaceuticals biologics medical devices natural health products

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Health product infowatch December 2023 pharmaceuticals biologics medical devices natural health products

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Health product infowatch January 2024 pharmaceuticals biologics medical devices natural health products