Establishment Licences

Establishment Licence Live Listing

Renewal Documents

Drugs

• Drug Establishment Licences
• Drug Establishment Licence Listing (DEL)
• Guidance on Evidence to Demonstrate Drug Compliance of Foreign Sites (GUI-0080)
• Drug Establishment Licence Application: Form and Instructions
• Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
• Fee Reduction Request for Drug Establishment Licence
• GMP Inspection Policy for Canadian Drug Establishments (POL-0011)
• Guidance on Drug Establishment Licences (GUIDE-0002)

Medical Devices

• Medical Device Establishment Licences
• Medical Devices Establishment Licence Listing (MDEL)
• Guidance on Medical Device Compliance and Enforcement(GUI-0073)
• Guidance on Medical Device Establishment Licensing
• Guidance on the Medical Device Inspection Programme
• Inspection Strategy for Medical Device Companies
• Medical Device Establishment Licence: Fee Reduction Request
• Medical Devices Establishment Licence Application Form

Export

• Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported
• Export Certificate (FRM-0176)
• Request for Stamping
• Guidance Document on the application for Certificate of a Pharmaceutical Product (GUIDE-0024)

CTO Registration

• Draft Guidance Document: Cells, Tissues and Organs (CTO) for Transplantation
• Human Cells, Tissues and Organs (CTO) for Transplantation Registration Application Form (FRM-0171)