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Catalogue Entry: Submitting risk management plans draft guidance document: RMP summary template
The RMP summary should include specific sections, which mirror the EU RMP Summary format sections.-
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Catalogue Entry: Submitting risk management plans draft guidance document: Opioid products
Opioid products need to include specific content within their RMP to address: the risk and uncertainties of opioid-related harms in Canada and other risks and uncertainties...-
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Catalogue Entry: Submitting risk management plans draft guidance document: Procedures to submit
Information on risk management plan submissions for drugs including when to file, considerations, requirements, and compliance.-
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Catalogue Entry: Submitting risk management plans draft guidance document: Introduction
Health Canada has adopted and integrated the use of risk management plans (RMPs) and the International Conference on Harmonization (ICH) E2E Guideline into the regulatory review...-
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Catalogue Entry: Regulatory Requirements for Advertising
Only health products that Health Canada authorizes for sale in Canada may be advertised. Specific requirements exist for advertisements of prescription drugs to consumers.-
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Catalogue Entry: Regulating health products
Learn how Health Canada makes sure that the health products you use are safe, effective and of high quality.-
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Catalogue Entry: Regulating Advertising of Health Products
Health Canada sets the standards for health product advertising material in Canada to help advertisers produce messages that are not false, misleading or deceptive.-
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Catalogue Entry: Reporting adverse reactions to marketed health products - Guidance document...
This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural...-
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Catalogue Entry: Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making
Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions.-
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Catalogue Entry: Notice of clarification to drug manufacturers and sponsors:...
We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the risk management plans (RMPs) for...-
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Catalogue Entry: Notice of clarification to drug manufacturers and sponsors - Risk Management...
This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled...-
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Catalogue Entry: Module 4: Health Canada’s review and communication of safety findings
Educational module provides overview of health product vigilance, report management, post-market surveillance activities and Health Canada risk communications.-
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Catalogue Entry: Module 3: Strategies to promote and support mandatory reporting
Educational module helps identify and overcome barriers to hospital mandatory reporting of adverse drug reactions and medical device incidents, recognize opportunities and...-
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Catalogue Entry: Module 2: Reporting processes to Health Canada
Educational module includes considerations for mandatory reporting of adverse drug reactions and medical device incidents, reporting options to Health Canada, differentiating...-
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Catalogue Entry: Module 1: Overview of Vanessa’s Law and reporting requirements
Educational module includes an outline of Vanessa’s Law, who/what/when of regulations for mandatory reporting of adverse drug reactions and medical device incidents, required...-
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Catalogue Entry: Let's talk about acetaminophen
Acetaminophen is safe and effective when used as directed, but there is a limit to how much you can take in one day. Taking more than the recommended dose can cause severe or...-
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Catalogue Entry: Laser eye surgery
Thousands of Canadians are turning to laser eye surgery to correct their vision and eliminate their dependency on glasses or contact lenses. Like all medical procedures, laser...-
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Catalogue Entry: Health Canada's Response to the Carlin Jury Recommendations Aimed at the...
Health Canada's top priority is protecting the health and safety of Canadians. The department has a strong record of enhancing drug safety in Canada and is continually looking...-
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Catalogue Entry: Canadian Student Tobacco, Alcohol and Drugs Survey (CSTADS) 2021-2022 Public...
The Canadian Student Tobacco, Alcohol and Drugs Survey (CSTADS) is a biennial school-based survey of alcohol, cannabis, tobacco and drug use among Canadian students in grades 7... -
Catalogue Entry: Airborne Radionuclide Concentrations Dataset
The Airborne Radionuclide Concentrations (ARC) Dataset is a general dataset of airborne radionuclide concentrations analyzed at the Radiation Protection Bureau (RPB). The RPB is...