Directives, Guidance Documents and Policies - Establishment Licences - Drugs and Health Products - Health Canada

Directives

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

Guidance Documents

• Guidance on obtaining electronic certificates of pharmaceutical product and good manufacturing practices (GUI-0024)
• Draft guidance for exceptional importation and sale of medical devices [2022-02-16]
• Guidance on Medical Device Establishment Licensing (GUI-0016) [2020-04-01]
• Guidance on Drug Establisment Licences and Associated Fees (GUI-0002)
• Medical Device Establishment Licence: Calculation Chart [Updated 2015-04-01]
• Medical Device Compliance and Enforcement Directive (GUI-0073) [2015-06-12]
• Draft Guidance Document: HPFBI Guidelines for Recall of Drug and Natural Health Products. (GUIDE-0039) [2008-01-18]
• Explanatory notes for drug establishments on the preparation of a site master file (GUI-0005)
• Guidance on Evidence to Demonstrate Drug Compliance of Foreign Sites (GUI-0080)

Policies

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