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Drugs and Health Products
What's New - 2012
- Drug and Medical Device Recall Listings [2012-12-24]
- Drug Establishment Licensing
- Summary report of the Drug Good Manufacturing Practices (GMP) Inspection Program - April 1, 2006 to March 31, 2011 [2012-12-21]
- Medical Device Establishment Licensing
- Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016)[2012-12-12]
- Medical Device Establishment Licence Application Form and Instructions (FRM-0292) [2012-12-12]
- Medical Device Establishment Licence Annual Review 2013 [2012-12-12]
- Medical Device Establishment Licensing and Fees - Frequently Asked Questions [2012-12-12]
- Medical Device Establishment Licensing Application Completion Checklist [2012-12-12]
- Medical Device Establishment Licence: Calculation Chart [2012-12-12]
- Summary Report: Stakeholder Consultation Workbook for the Cells, Tissues and Organs (CTO) Programs Inspection Strategy [2012-11-21]
- Inspection Strategy for Cells, Tissues and Organs Establishements (POL-0057) [2012-11-21]
- 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]
- Human Cells, Tissues and Organs for Transplantation - Error or Accident Investigation Preliminary Report Form (FRM-0172) [2012-11-06]
- Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104) [2012-10-22]
- Cost-Benefit Analysis: Regulations Amending the Food and Drug Regulations – Good Manufacturing Practices for Active Ingredients [2012-10-18]
- Cost-Benefit Analysis Supplemental: Small Business Lens under the Cabinet Directive on Regulatory Management [2012-10-18]
- Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049) [2012-09-25]
- Process Validation: Form-Fill-Seal for Drugs (GUI-0008) [2012-09-25]
- Risk Classification of Good Manufacturing Practices (GMP) Observations (GUI-0023) [2012-09-11]
- Notice to Stakeholders: Foreign Sites - Expiring; Change to Expiry Calculation [2012-08-29]
- Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2012-08-10]
- Drug Establishment Licence Application Completion Checklist [2012-07-05]
- Medical Device Establishment Licence Application Completion Checklist [2012-07-05]
- Compressed Gas Association (CGA) - Minutes of meeting - July 26, 2011 [2012-04-25]
- Compressed Gas Association (CGA) - Minutes of meeting - November 25, 2010 [2012-04-25]
- Compressed Gas Association (CGA) - Minutes of meeting - April 20, 2010 [2012-04-25]
- Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101) [2012-04-04]
- Quality System Framework 2012 [2012-04-04]
- Mutual Recognition Agreements Updates [2012-04-04]
- Guidance on the Application for a Certificate of a Pharmaceutical Product (GUI-0024) [2012-04-01]
- Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) [2012-04-01]
- Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2012-04-01]
- Summary Report of Inspections of Clinical Trials conducted from April 2004 to March 2011 [2012-03-28]
