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Exceptions to the Prescription Drug List: Closed consultation From: Health Canada Current status: Closed This consultation ran from July 28, 2022 to November 29, 2022. We sought input from health care providers and other stakeholders on current exceptions to the Prescription Drug…

Post-Drug Identification Number (DIN) Changes Guidance Document Assignment of Drug Identification Numbers (DINs) According to Product Name Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales Food and Drugs Act Food and Drug Regulations…

Notice: Revisions to the performance standards for Post-authorization Division 1 Changes August 2, 2022 Our file number: 22-107706-88 Health Canada is revising the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and…

Notice: Revision to the Guidance Document Management of Drug Submissions and Applications (August 2022) August 2, 2022 Our file number: 22-107705-486 Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This…

Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-08-17] Date: August 17, 2022 Our file number: 22-109195-425 The purpose of this Notice of Amendment is to notify about the additions of avacopan, berotralstat, capmatinib, faricimab, mogamulizumab, selinexor,…

Guidance on veterinary drug labelling: Overview Overview General labelling requirements Specific requirements for label content and format Package insert Labelling of unique types of packages Annexes On this page Purpose Scope and application Definitions Note about guidance…

Health Canada to monitor the inclusion of disaggregated data in clinical evidence: Notice to stakeholders On this page Purpose Background Implementation Contact us Purpose This notice is to inform stakeholders that Health Canada will be using a questionnaire to verify if…

Qualifying notice for Yescarta - Canada.ca

Health CanadaCaptures 12Dernière capture 11 avr. 2026en

Qualifying notice for Yescarta Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney’s Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: HC6-024-E214145 Control #: 256106 [employee name removed] [employee title removed] Gilead Sciences…

Notice: Multiple additions to the Prescription Drug List (PDL) October 14, 2022 Our file number: 22-110895-558 The purpose of this Notice of Amendment is to notify about the addition of abrocitinib, asciminb, belzutifan, difelikefalin, maribavir and tezepelumab to the…

Notice to stakeholders: Health Canada's expectations regarding risk-management measures for clinical trials involving psychedelic-assisted psychotherapy December 5, 2022 Our file number: 22-111811-471 Purpose Health Canada recognizes the growing interest in the use of…

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