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Proposed Re-evaluation Decision PRVD2022-09, Bacillus amyloliquefaciens...
Bacillus amyloliquefaciens strain MBI600 is a naturally occurring bacteria which suppresses plant diseases by preventing growth of pathogenic fungi through displacement and... -
Submitting risk management plans draft guidance document: Canadian-specific...
A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and measures that the manufacturer intends to take that are unique... -
Guidance Document: Use of Certificates of Suitability as supporting...
The purpose of the guidance document is to outline the requirements when preparing submissions that rely on Certificates of Suitability (CEPs) issued by the European Directorate... -
Backgrounder: New Canada Health Act Initiatives (August 2018)
The Government of Canada is moving forward with three new initiatives related to the Canada Health Act. In August 2018, the Minister of Health issued letters to the provinces... -
Cosmetic-Drug Interface
The Guidance on the Classification of Products at the Cosmetic-Drug Interface clarifies how Health Canada interprets and applies the definitions of cosmetic and drug in the Food... -
Explanatory note: Order Respecting Certain Time Limits under the Food and...
The objective of this Ministerial Order is to ensure that Health Canada is able to review all applications for new clinical trials or amendments to ongoing trials within the... -
Food Safety Resources
Help promote food safety through your organization with Health Canada’s new Food Safety Toolkit. The Toolkit is designed to help your organization raise awareness about the... -
Special Review Decision SRD2021-02, Special Review Decision: Linuron and Its...
This document presents the final regulatory decision for the special review of linuron. A reference list of information used as the basis for the proposed special review... -
Canada Consumer Product Safety Act - Information for Retailers
Product safety is in everyone's best interest. Under the Canada Consumer Product Safety Act you have certain responsibilities as a seller of consumer products. -
Monitoring System for Medical Assistance in Dying in Canada
The federal legislation sets out several requirements for the federal government in order to implement a monitoring and reporting system for medical assistance in dying in Canada. -
Health Canada’s regulatory response to COVID-19: Access to health products
Health Canada introduced innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety,... -
Non-prescription Drugs: Category IV Monographs
A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings,... -
Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device...
Reports about serious ADRs and MDIs can be important signals of emerging safety issues. Such post-market observations can also lead to improved safety information about a product. -
Guidance Document: Drug Identification Numbers for Schedule C Drugs...
On December 13, 2017, Health Canada published the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs in Dosage Form Listed in Schedule C to the Food... -
Data requirements for switching medicinal ingredients from prescription to...
This guidance document provides information to help sponsors determine what evidence should be submitted to Health Canada when applying to switch a medicinal ingredient from... -
Eye health
Health Canada approved one new generic drug for eye health. -
Summary: Proposed new guidance pieces for the Novel Foods Regulation,...
These new guidance pieces will introduce new elements to the existing 2006 Guidelines for the Safety Assessment of Novel foods, including: Guidance on foods derived from... -
Canada-Ontario Home and Community Care and Mental Health and Addictions...
Canada and Ontario agreed to a Common Statement of Principles on Shared Health Priorities (hereinafter referred to as the Common Statement, attached hereto as Annex 1) on August... -
Fifth Report on Human Biomonitoring of Environmental Chemicals in Canada
These data tables present national data on concentrations of environmental chemicals in Canadians. These data were collected as part of an ongoing national direct health... -
Phosphoric Acid Derivatives Group
These substances were identified for action under the Chemicals Management Plan (CMP). The screening assessment focuses on 3 of 6 substances referred to collectively as the...