Blood and Donor Semen

Blood

• Inspection Strategy for Blood and Source Plasma Establishments (POL-0039) [2010-07-23]
• Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061)[2010-04-29]
• Guidance Document: Human Plasma Collected by Plasmapheresis
• Drug Establishment Licence Application: Form and Instructions
• Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2011-04-01]
• Product Recall Procedures
• Annex 14 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule D Drugs, Human Blood and Blood Components (GUI-0032) [2012-11-09]

Donor Semen

• List of Canadian Establishments that Process and/or Import Semen for Assisted Conception [2013-06-17]
• Inspection Strategy for Semen Establishments (POLICY-0023)
• Guidance and Directives
  • Risk Classification of Observations to Donor Semen Establishments (GUI-0053)
  • Guidance on the Processing and Distribution of Semen for Assisted Conception Regulations (GUIDE-0041)
  • Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access
  • Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination
  • Guidance on Donor Semen Special Access Programme: Alternative Test Requirements
  • Therapeutic Products Programme Guidance on the Donor Semen Special Access Program
•  Processing and Distribution of Semen for Assisted Conception Regulations

Enforcement Guides and Policies

• Drugs - Guidance Documents, Directives and Policies
• Quality System Framework - Summary
• Health Products and Food Branch Inspectorate - Recall Policy
  (POL-0016)
• Compliance and Enforcement Policy (POL-0001)