Forms

Alternate Sample Retention Site

• Guidance Document - Alternate Sample Retention Site Guidelines (GUI-0014) [2011-11-18]

Canada's Access to Medicines Regime

• Guidance for Pre-manufacturing and Pre-exportation Notifications under Canada's Access to Medicines Regime (GUIDE-0072)

Drugs under Foreign Ownership

• Notification Form / Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership (GUIDE-0067)

Foreign Sites (August 1, 2009)

• Good Manufacturing Practices - Audit Report Form (FRM-0211)
• Good Manufacturing Practices - Audit Report Form (FRM-0211) - Instructions
• Good Manufacturing Practices - Foreign Site Submission Form (FRM-0212)
• Good Manufacturing Practices - Request for Inspection of a Foreign Site Form (FRM-0213)
• Good Manufacturing Practices - Foreign Site Inspection Services Agreement Form (FRM-0214)

Products being Exported - Section 37

• Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported