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Notice of Intent: Transitioning Product Monographs to a Structured Format April 10, 2019 Our file number: 19-107892-703 Health Canada is pleased to announce its intent to transition product monograph templates to a new structured format based on Extensible Markup Language (XML),…
Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs - document Date adopted: 2015/04/30 Date posted: 2020/03/23 Effective date: 2020/04/01 PDF version Document change log Version Guidance Document: Questions and Answers: Plain Language Labelling…
Notice - Final Release: Part I - Health Professional Information and Part II - Scientific Information of the Guidance Document - Product Monograph December 9, 2016 Reference number: 16-113259-317 This notice was updated on May 12, 2020. Under the continuing efforts of the Health…
Notice: Product Monograph Implementation Plans May 12, 2020 Our Reference No: 19-123473-315 UPDATE: In light of current priorities and circumstances related to COVID-19, Health Canada is revising the Product Monograph Implementation timelines. Health Canada will initiate Phase I:…
Product monograph guidance documents and notices Contact: Bureau of Policy, Science and International Programs On this page Product monograph guidance Notices Archived notices Product monograph guidance Guidance Document: Product Monograph [2024-12-23] Product Monograph Master…
Border requirements for importing and exporting health products (COVID-19) There is an unprecedented demand and urgent need for access to health products during the COVID-19 pandemic. As part of Canada's response to COVID-19, interim measures and interim orders (IO) are in place…
Health Canada’s regulatory response to COVID-19: International engagement Access to health products International engagement During the COVID-19 pandemic, Health Canada is working closely with domestic and international partners to anticipate and meet Canadians' health product…
Drug and vaccine authorizations for COVID-19: Overview Overview List of applications received List of authorized drugs On this page About market authorization Prioritizing COVID-19 applications and being transparent Authorization pathways for COVID-19 drugs and vaccines…
Conducting a COVID-19 drug and vaccine clinical trial Conducting a COVID-19 clinical trial List of authorized clinical trials On this page Clinical trial regulations Applying to conduct a clinical trial for COVID-19 purposes Clinical trial regulations Clinical trials are studies…
Drugs and vaccines for COVID-19 On this page Regulatory response to COVID-19 Regulating drugs and vaccines sold in Canada Monitoring SARS-CoV-2 variants Potential drugs and vaccines for COVID-19 Clinical trials for drugs and vaccines Market authorization Special Access Program…
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