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Information by Health Product The Health Products and Food Branch Inspectorate is responsible for branch-wide compliance and enforcement activities, enabling consistency of approach across the spectrum of regulated products. The Inspectorate core functions are compliance…

Import and export of drugs and health products: Compliance and enforcement Importing and exporting health products is regulated under the Food and Drugs Act and its associated Regulations. Some health products may also have additional restrictions placed on them by other Acts and…

Good manufacturing practices Health Canada is supporting drug establishment licence holders by providing temporary measures due to COVID-19. For more information, please visit DEL and GMP temporary measures due to COVID-19 . On this page What are good manufacturing practices Drug…

Good Clinical Practices The Regulatory Operations and Enforcement Branch (ROEB) has the responsibility for the inspections and investigations of clinical trials. These new functions were announced in January 2000, and along with the publication in June of the new Regulations on…

Establishment Licences For industry information about COVID-19, visit our COVID-19 health product industry section. Establishment Licence Live Listing Drug and health product inspections Medical Devices Establishment Licence Listing (MDEL) Good Manufacturing Practices (GMP)…

Enforcement Activities The Health Products and Food Branch Inspectorate (Inspectorate) is responsible for activities concerning compliance and enforcement of the Food and Drugs Act (with the exception of products regulated as foods which are the responsibility of the Canadian…

Registration and notification guide for donor sperm and ova establishments (GUI-0128) Date issued: 2022 Date implemented: 2022 Replaces: N/A On this page Overview Guidance Registration Notification Importation Distribution Annual attestation Appendix A: Glossary Appendix B:…

Compliance and Enforcement As part of its regulatory responsibilities, Health Canada is responsible for compliance monitoring and enforcement activities related to health products in order to verify that regulatory requirements are being applied appropriately. What information…

Reporting a complaint for the Assisted Human Reproduction Act Health Canada is committed to verifying complaints from Canadians (e.g., donors, surrogates, intended parents, children born of assisted human reproduction (AHR), healthcare professionals, and clinics) and industry…

Reporting complaints about health products Health Canada encourages individuals to send in their complaints about health products to the Regulatory Operations and Enforcement Branch (ROEB). ROEB manages health product complaints on a priority basis according to the risk to…