Topics
	Directives, Guidance Documents & Policies
	Drug Establishment Licences
	Forms
	Medical Device Establishment Licences
	Renewal Documents
	Suspension of Establishment Licence

Establishment Licences

Establishment Licence Live Listing

Renewal Documents

Drugs

• Companies that hold a Drug Establishment Licence
• GMP Inspection Policy for Canadian Drug Establishments (POL-0011)
• Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
• Drug Establishment Licence Application: Form and Instructions
• Conditions of Acceptance of Foreign Inspection Reports for Listing Foreign Sites on Canadian Establishment Licences
• Fee Reduction Request for Drug Establishment Licence
• Guidance Document on Drug Establishment Licences and Establishment Licensing Fees

Medical Devices

• Guidance on Medical Device Establishment Licensing
• Companies that hold a Medical Device Establishment Licence
• Medical Device Compliance and Enforcement Directive (POL-0045)
• Guidance on the Medical Device Inspection Programme
• Medical Devices Establishment Licence Application Form
• Inspection Strategy for Medical Device Companies
• Medical Device Establishment Licence: Fee Reduction Request

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• Draft Guidance Document: Cells, Tissues and Organs (CTO) for Transplantation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)
• Human Cells, Tissues and Organs for Transplantation - Error or Accident Prelimanary Investigation Report Form (FRM-0172)