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Policies Policy documents are interpretations of the purpose and intent of the Food and Drugs Act and Regulations. Notice: Application of the definition of Canadian Reference Product [2024-01-26] Policy statement: Use of pharmacometrics in drug submissions and clinical trial…

Notice: Re: Category IV / Labelling Standards Submission Application Process Review December 19, 2006 (PDF Version - 65 K) Contact: BGIVD Enquiries Notice Our file number: 06-129002-483 Re: Category IV / Labelling Standards Submission Application Process Review Category IV…

Submissions Containing Clinical Data from Studies Conducted outside of Canada Contact: Bureau of Policy, Science and International Programs Enquiries June 5, 2009 Notice Our file number: 09-114651-928 Submissions Containing Clinical Data from Studies Conducted outside of Canada…

Notice - Regulatory Cooperation Council (RCC) Over-the-Counter (OTC) Products - Common Monograph Working Group - Selection of a Monograph for Alignment (PDF Version - 18 K) January 10, 2013 Our file number: 12-122540-781 Health Canada is pleased to announce the launch of the…

Notice - Reconsideration of Decisions Issued for Human Drug Submissions April 1st Notice Our file number: 15-103791-905 Release of the revised: Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions Health Canada is pleased to announce the release of…

Notice - Release of the Final Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience) (PDF Version - 32 K) May 1, 2015 Notice Our file number: 15-104593-161 Release of the Final Guidance Document: Drug Submissions Relying on Third-Party…

Updates to the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use September 15, 2015 Our file number: 15-109734-699 Notice On June 19, 2013, Health Canada published in Canada Gazette , Part II amendments to the Food and Drug Regulations . The Regulations Amending…

Notice: Updates to the Guidance Document: Fees for the Review of Drug Submissions and Applications November 6, 2015 Our file number: 15-111707-967 On July 2, 2014, Health Canada published in the Canada Gazette , Part II, the Regulations Amending the Food and Drug Regulations…

Notice - Antimicrobials Product Labelling November 16, 2015 Our reference number: 15-112507-157 Responding to the threat of Antimicrobial Resistance (AMR) has been at the forefront of recent international discussions due to the increasing concern of resistance to antibiotics for…

Update: Implementation of Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document: Product Monograph November 20, 2015 Our reference number: 15-111865-364 In April 2014, Health Canada announced the final release of…