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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.

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Consultation on the Risk classification guide of observations related to clinical trial inspections of human drugs (GUI-0043) From Health Canada Current status: Closed Opened for consultation on November 15, 2021 and closed to new input on December 14, 2021. Health Canada is…

Extension of interim enforcement approach for federal, provincial and territorial COVID-19 testing initiatives Medical Devices Compliance Program Bulletin, December 21, 2022 In the ongoing interest of public health, the Interim enforcement approach for federal, provincial and…

Updated guidance on how to apply for a manufacturer's certificate to export (MCE) MDEL Bulletin, January 18, 2023, from the Medical Devices Compliance Program On this page Background Key changes in the guide Process to apply for an MCE Contact us Background Remote working…

Medical Device Establishment Licences - Canada.ca

Health CanadaCaptures 11Latest capture Apr 11, 2026en

Medical Device Establishment Licences Medical Devices Annual Review Documents Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097) Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2015-06-12] Medical Devices Establishment…

Export Certificate for Drugs Exported Under Section 37 of the Food and Drugs Act (PDF Version - 129 K) Exporters exporting drugs in compliance with section 37 of the Food and Drugs Act are required to issue an export certificate in accordance with section A.01.045 of the Food and…

Forms – Establishment licences – Drugs and health products Drugs Drug Establishment Licence Application Forms and Instructions (FRM-0033) [2014-10-23] Table A: Foreign Building Conducting Active Pharmaceutical Ingredients Related Licensable Activities Medical Device Medical…

Directives, Guidance Documents and Policies - Establishment Licences - Drugs and Health Products - Health Canada Directives Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004) Guidance Documents Guidance on obtaining…

Annual Review Documents - Canada.ca

Health CanadaCaptures 11Latest capture Apr 11, 2026en

Annual Review Documents As of April 1, 2011, establishment licences will no longer expire on December 31 of each year. In order to continue to hold a valid establishment licence, an application for annual review along with the appropriate payment must be submitted to Health…

Archived Importation and Exportation Good Manufacturing Practices (GMP) Questions and Answers - Drug and Health Products (PDF Version - 51 K) Unit Name : Drug GMP Inspection Unit Telephone : 613-957-1492 Fax : 613-957-6709 Email : GMP_questions_BPF@hc-sc.gc.ca The Importation and…

Guidance on obtaining electronic certificates of pharmaceutical product and good manufacturing practices (GUI-0024) Download in PDF format (344 KB, 13 page) Organization: Health Canada Date published: 2023-03-27 March 2023 Date approved: March 27, 2023 Effective date: March 27,…

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