Directives, Guidance Documents & Policies

Directives

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

Guidance Documents

• Medical Device Establishment Licence: Calculation Chart [2011-07-12]
  
• Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2011-04-01]
• Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUIDE-0024) [2011-02-04]
• Medical Device Compliance and Enforcement Directive (GUI-0073)
• Draft Guidance Document: HPFBI Guidelines for Recall of Drug and Natural Health Products. (GUIDE-0039) [2008-01-18]
  
• PIC/S Annex 1: Explanatory Notes for Industry on the Preparation of a Site Master file (January 18, 2008)
  
• Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) [2011-04-01]
  
• Guidance on Evidence to Demonstrate Drug Compliance of Foreign Sites (GUI-0080)
• Guidance on the Medical Device Inspection Programme
• Inspection Strategy for Medical Device Companies (POL-0035) [2011-08-12]

Policies

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