Health Canada Regulatory Transaction Form

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REP Templates for Health Canada

(2 days ago) WEBRegulatory Transaction (RT) Template (updated on 2023-02-28) Required with each regulatory transaction filed to Health Canada. Sent via the CESG in folder 1.2.1 for …

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

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Common Electronic Submissions Gateway - canada.ca

(7 days ago) WEBThe CESG allows Trading Partners provide regulatory transactions to Health Canada electronically, i.e. an "electronic" courier. The CESG has been the mandatory method of transmission for regulatory transaction …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/common-electronic-submissions-gateway/frequently-asked-questions.html

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Regulatory Enrolment Process (REP) Template Revision History

(2 days ago) WEBHealth Canada has updated the Regulatory Enrolment Process (REP) templates to reflect process changes and improvements. Refer to the Guidance Document: Regulatory …

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

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Forms: Applications and submissions for drug products - Canada.ca

(9 days ago) WEBDetails for Payment of Invoice (formerly Details of Payment of a Drug Submission Invoice) [2020-03-23] Drug Establishment Licence Application Form (FRM …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/forms.html

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Guidance Document

(2 days ago) WEBEnrolment: The process of providing Health Canada information related to a company using a draft CO file, and in return receiving a Company ID from Health Canada using a …

https://publications.gc.ca/collections/collection_2024/sc-hc/H164-292-2024-eng.pdf

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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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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 …

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

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Organization and document placement for Canadian module 1

(2 days ago) WEBThis document contains a table outlining the Canadian module 1 sections and subfolders, with a list of possible documents. Sponsors must use this table to determine …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/organization-document-placement-canadian-module-1.html

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Regulatory submissions and transactions with Health Canada

(8 days ago) WEBStarting January 1, 2020, all regulatory transactions for Master Files prepared in the non-eCTD format must be sent via the Common Electronic Submission …

https://www.certara.com/blog/regulatory-submissions-and-transactions-with-health-canada/

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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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Clinical Trial Regulatory Activities in eCTD - CAPRA

(4 days ago) WEBAuthor: Preetha Prabhu. On February 19, 2020, Health Canada announced that the pilot for Clinical Trial regulatory activities in electronic Common Technical …

https://capra.ca/en/blog/clinical-trial-regulatory-activities-in-ectd-2020-03-02.htm

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Health Canada's Regulatory Enrollment Process REP Purpose

(8 days ago) WEB1. Purpose of REP. REP has been designed to modernize how regulatory information is shared with Health Canada. The primary purpose of using this program is …

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

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Important Changes to Health Canada’s Regulatory Enrolment …

(5 days ago) WEBThe REP Regulatory Transaction (RT) and Product Information (PI) templates replace existing Health Canada forms such as the HC-SC3011 drug …

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

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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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Validation rules for regulatory transactions provided to Health …

(8 days ago) WEB6/7/22, 11:27 AM Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format - Canada.ca password set, excluding Health Canada. …

https://pink.citeline.com/-/media/supporting-documents/pink-sheet/2022/06/p0622can_3.pdf

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