Directives, Guidance Documents & Policies

Directives

• Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)

Guidance Documents

• Guidance on Medical Device Establishment Licensing
  
• Conditions of Acceptance of Foreign Inspection Reports for Listing Foreign Sites on Canadian Establishment Licences


• Guidance Document on Drug Establishment Licences and Establishment Licensing Fees
  
• Guidance Document on the Application for Certificate of a Pharmaceutical Product (GUIDE-0024)
  
• Guidance on the Medical Device Inspection Programme


• Inspection Strategy for Medical Device Companies


• Site Reference File Guideline

Policies

• GMP Inspection Policy for Canadian Drug Establishments (POL-0011)


• Medical Device Compliance and Enforcement Directive (POL-0045)