Ybpr Template Health Canada
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Yearly Biologic Product Report Template - annotated version
(9 days ago) Yearly Biologic Product Report (YBPR) is a requirement that applies to Schedule D (biologic) drugs assigned to Evaluation Groups 2, 3, and 4, as … See more
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Guidance for Sponsors: Lot Release Program for Schedule D …
(5 days ago) WEBManufacturers of Schedule D (biologic) drugs in Evaluation Groups 2, 3, and 4 shall provide, under section C.01.014.5 Footnote 4, C08.007 Footnote 5 and/or C.08.008 of …
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Yearly Biologic Product Report… The YBPR and you
(6 days ago) WEBYBPR format • Three options to consider: • Modify an existing annual report prepared for the FDA or EMEA to reflect the Canadian approval status • Prepare a Canadian-specific …
https://capra.ca/_uploads/archive/presentations/13-NancyGreen-YBPRUpdate.pdf
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Guidance Document
(2 days ago) WEBHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …
https://publications.gc.ca/collections/collection_2019/sc-hc/H164-267-2019-eng.pdf
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Biologic and Radiopharmaceutical Drugs Directorate
(6 days ago) WEBAny questions or comments on this report should be forwarded to: Office of Submissions and Intellectual Property, Resource Management and Operations Directorate Finance …
https://www.publications.gc.ca/collections/collection_2021/sc-hc/H162-5-2021-1-eng.pdf
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Product Information Template: Regulatory Enrolment Process
(6 days ago) WEBPurpose of collection: Health Canada requires the personal information to process regulatory application forms related to human and veterinary drug products under the …
https://health-products.canada.ca/rep-pir/v44/product/product.html
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Biologics and Genetic Therapies Directorate
(4 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many consumer …
https://www.publications.gc.ca/collections/collection_2019/sc-hc/H166-4-2019-eng.pdf
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Biologics and Genetic Therapies Directorate
(Just Now) WEBAny questions or comments on this report should be forwarded to: Office of Submissions and Intellectual Property, Resource Management and Operations Directorate Finance …
https://publications.gc.ca/collections/collection_2020/sc-hc/H2-2-2019-3-eng.pdf
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Guidance Document
(2 days ago) WEBHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …
https://publications.gc.ca/collections/collection_2021/sc-hc/H164-293-2019-eng.pdf
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Regulatory Transaction Template: Regulatory Enrolment Process
(5 days ago) WEBFrom Health Canada. Date modified: 2024-05-01. Regulatory Transaction Template: Regulatory Enrolment Process (REP) (Version 4.4.2) From Health Canada. Report a …
https://health-products.canada.ca/rep-pir/v44/transaction/regulatory-transaction.html
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Biologic and Radiopharmaceutical Drugs Directorate
(5 days ago) WEBAny questions or comments on this report should be forwarded to: Office of Submissions and Intellectual Property Resource Management and Operations Directorate Finance …
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REP Templates for Health Canada
(2 days ago) WEBCompany (CO) Template (updated 2023-02-28) Required to obtain a company ID and/or update company information to Health Canada. Sent via email. Attach draft CO XML file …
https://health-products.canada.ca/rep-pir/index.html
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Standardized Health Product Risk Communication Template
(9 days ago) WEBAction taken by Health Canada. Text describing any risk management measures (e.g., [specific section] of the product monograph will be updated to reflect the …
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Biologics and Radiopharmaceutical Drugs Directorate
(5 days ago) WEBNAS Biontech Manufacturing GMBH 10-06-2021 16-09-2021. 8The CR Date is the date the submission is received and considered administratively complete by Health Canada. …
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Yearly Biologic Product Reports: Questions and Answers
(9 days ago) WEBHealth Canada has the authority to request a YBPR based on section C.01.014.5, C08.007 and/or C.08.008 of the Food and Drug Regulations, which requires manufacturers of …
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Company Template: Regulatory Enrolment Process - Canada.ca
(2 days ago) WEBPurpose of collection: Health Canada requires the personal information to process regulatory application forms related to human and veterinary drug products under the …
https://health-products.canada.ca/rep-pir/company/company.html
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Health Canada Lot Release Program for Biologic Drugs
(4 days ago) WEB1.2 The Lot Release Program. Each lot of a Schedule D (biologic) drug is subject to the Lot Release Program before sale1 in Canada. The risk-based Lot Release …
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Guide for using the Standardized Health Product Risk …
(5 days ago) WEBPurpose. This guide is intended to assist in the drafting of risk communications, using the standardized template to communicate health product …
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