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Notice to Stakeholders: Release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug May 15, 2017 Our file number: 17-105256-845 Health Canada is pleased to announce the release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug . This…

Notice: Publication of Update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations May 17, 2017 Our file number: 17-105376-499 Health Canada is pleased to announce the publication of an update to the Guidance Document: Data Protection under…

Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) October 30, 2017 Our file number: 17-109365-631 A final version of the following Guidance Documents and…

Notice - Amendments to the Food and Drug Regulations for Mica December 21, 2017 Our file number: 17-114005-350 Health Canada intends to amend the Food and Drug Regulations to permit the use of mica coated with titanium dioxide and/or iron oxide as colouring agents in drugs for…

Notice: Publication of Update to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations May 11, 2018 Our file Number: 18-104750-127 Health Canada is pleased to announce the publication of an update to the Guidance Document: Patented Medicines (Notice of…

Notice: Revision of Guidance documents: Conduct and Analysis of Comparative Bioavailability Studies & Comparative Bioavailability Standards: Formulations used for Systemic Effects June 8, 2018 Our file number: 18-104623-884 Health Canada is pleased to announce the revision of two…

Notice: Health Canada Review of Vitamin D Levels for Non-Prescription Use June 4, 2018 Our file number: 18-104907-757 The current non-prescription limit of 1,000 International Units (IU) for vitamin D was added to Schedule F (now the Prescription Drug List (PDL)) in 1997. Since…

Notice of Intent to Restrict the Marketing and Advertising of Opioids Prescription opioids can help Canadians who need them to manage pain. However, over-prescription of opioids has contributed to Canada’s current opioid crisis. To help address this issue, Health Canada intends…

Notice: Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy June 26, 2018 Our file number: 18-103273-150 Health Canada is pleased to announce the release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes…

Explanatory Note Epinephrine - Canada.ca

Health CanadaCaptures 12Latest capture Apr 11, 2026en

Explanatory Note Epinephrine Interim Order Respecting Epinephrine Auto-injectors (This note is not part of the Order.) Proposal The Interim Order Respecting Epinephrine Auto-injectors (the Interim Order) made by the Minister of Health on August 27, 2018 permits the immediate…

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