Health Canada Rep Forms

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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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Notice: Regulatory Enrolment Process (REP) …

(2 days ago) WEBHealth Canada is pleased to announce that the assessment of the REP pilot was generally positive. Therefore, we will begin REP implementation in August 2019. …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/notice-rep-implementation-expansion-cesg.html

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Implementing the regulatory enrolment process (REP) for …

(9 days ago) WEBREP medical device guidance document; These items will be posted on our REP information web page by December 2023. Announcement. Health Canada intends …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/regulatory-enrolment-process-medical-devices-regulatory-activities-notice.html

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Notice: Confirmation of the Mandatory use of the Regulatory

(8 days ago) WEBDate: July 6, 2020 Our file number: 20-1052634-535. By way of this update, Health Products and Food Branch (HPFB) is reminding sponsors that the mandatory date for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/notice.html

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Regulatory Enrolment Process (REP) Template Revision History

(2 days ago) WEBRegulatory Enrolment Process (REP) Template Revision History. Health Canada has updated the Regulatory Enrolment Process (REP) templates to reflect process changes …

https://health-products.canada.ca/rep-pir/version_history.html

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Regulatory enrolment process (REP) - Open Government Portal

(9 days ago) WEBThe Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to: company, dossier and product, regulatory activity, and regulatory …

https://open.canada.ca/data/info/0e0a226c-cda8-4a63-9825-1a040686097c

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Dossier ID request form for pharmaceutical/biologic dossiers

(8 days ago) WEBPharmaceutical. Biologic. Company ID (5 characters) (required) 2. Company Name (100 characters) (required) Intended date of filing – a request for dossier ID must be sent a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically/pharmaceutical-dossier-template.html

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Health Canada's Regulatory Enrollment Process REP Purpose

(8 days ago) WEBThis program captures information in a structured form. REP templates have replaced the previous processes, which were processing Health Canada forms and …

https://qualitysmartsolutions.com/blog/health-canadas-regulatory-enrollment-process-rep/

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Regulatory Transaction Template: Regulatory Enrolment Process

(Just Now) 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/transaction/regulatory-transaction.html?wbdisable=true

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Guidance on evaluation fees for human drugs and disinfectants

(2 days ago) WEBOverview. Health Canada has recently updated the Guidance document on fees for the review of human and disinfectant drug submissions and applications. The revised …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-317-2021-eng.pdf

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Important Changes to Health Canada’s Regulatory Enrolment …

(5 days ago) WEBBy: Teri Dickinson, Regulatory Affairs Group Manager, email As of October 1, 2020, all companies submitting regulatory information to Health Canada for hard surface …

https://delltech.com/blog/important-changes-to-health-canadas-regulatory-enrolment-process-rep/

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Health Canada announces REP Expansion RegDesk

(1 days ago) WEBHealth Canada announces REP Expansion. Jun 4, 2020. The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the …

https://www.regdesk.co/health-canada-announces-rep-expansion/

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Guidance document : preparation of regulatory activities in the

(1 days ago) WEBGuidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format.: H164-293/2019E-PDF "This guidance document …

https://publications.gc.ca/site/eng/9.882674/publication.html

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Canada Guidance: Regulatory Enrolment Process (REP)

(1 days ago) WEBHealth Canada's Regulatory Enrolment Process (REP) assists regulators in filing and processing regulatory information about: Company. Dossier and product. …

https://www.regulatoryaffairsnews.com/post/canada-guidance-regulatory-enrolment-process-rep

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Health Canada Regulatory Modernization: Yesterday, Today …

(9 days ago) WEBREP replaces the processes for the existing Health Canada 3011: Drug Submission Application Form and the Drug Submission - Application Fee Form for Human and …

https://www.certara.com/app/uploads/2021/03/WP_Health_Canada_Regulatory_Modernization.pdf

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Regulatory Enrolment Process: Mandatory effective October 1, …

(3 days ago) WEBAuthor: Preetha Prabhu. On Mar. 30, 2020, Health Canada published a notice that as of October 1, 2020 use of the Regulatory Enrolment Process (REP) will be …

https://capra.ca/en/blog/regulatory-enrolment-process-mandatory-effective-october-1-2020-2020-04-06.htm

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