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Drugs and Health Products
What's New - 2011
- Drug and Medical Device Recall Listings [2011-12-28]
- Consultation: Draft Guidance on Process Validation : Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074) [2011-12-16]
- Consultation: Cleaning Validation Guidance (GUI-0028) [2011-12-16]
- Consultation: Draft Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101) [2011-12-08]
- Developing a Model for Scheduling Inspections of Cells, Tissues and Organs Programs - Consultation Workbook [2011-12-08]
- Guidance Document - Alternate Sample Retention Site Guidelines (GUI-0014) [2011-11-18]
- List of Canadian Establishments that Proces and/or Import Semen for Assisted Conception [2011-11-16]
- Compressed Gas Association (CGA) - Procès-verbal de la réunion - Octobre 29, 2009 [2011-11-03]
- Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031) [2011-09-23]
- Inspection Strategy for Medical Device Companies (POL-0035) [2011-08-12]
- Medical Devices: Reviewing the Medical Devices Inspection Cycle - Consultation Workbook Instruction [2011-08-11]
- Human Cells, Tissues and Organs (CTO) for Transplantation Registration Application Form (FRM-0171) [2011-08-09]
- List of Registered Cells, Tissues and Organs (CTO) Establishments [2011-08-04]
- 2012 -Annual Review Drug Establishment Licences (DELS) letter [2011-07-29]
- Drug Establishment Licence Fee Form [2011-07-29]
- Emergency Contact Information Form [2011-07-29]
- Drug Establishment Licence Application Completion Checklist [2011-07-29]
- Guidance on Evidence to Demonstrate Drug Good Manufacturing Practices (GMP) Compliance on Foreign Sites (GUI-0080) - Current Practices letter [2011-07-29]
- Notice to Stakeholders - New for 2012 Drug Establishment Licence (DEL) Annual Review - Evidence to Demonstrate GMP Compliance of Foreign Sites [2011-07-29]
- 2011 Drug Establishment Fee Remission Applicants in Respect to Veterinary Use Only (Letter and Form) [2011-07-29]
- 2012 - Annual Review of Medical Device Establishment Licences (MDELS) letter [2011-07-29]
- Medical Device Establishment Licence Fee Form [2011-07-29]
- Medical Device Establishment Licence Application Completion Checklist [2011-07-29]
- Drug Establishment Good Manufacturing Practices - Pre-Application Package (Importers, Distributors and Wholesalers) [2011-07-22]
- Medical Device Establishment Licence: Calculation Chart [2011-07-12]
- Consultation: Draft Documents for Post-Market Reporting Compliance (PMRC) Inspection Program [2011-07-08]
- Mutual Recognition Agreements Updates [2011-06-10]
- Medical Device Program Information Sessions [2011-05-20]
- Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs (GUI-0012) [2011-05-13]
- Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2011-04-01]
- Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) [2011-04-01]
- Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) [2011-04-01]
- Drug Establishment Licence Application:Forms and Instructions (FRM-0033) [2011-04-01]
- Notice: Health Products and Food Branch Inspectorate - Establishment Licensing - Important Upcoming Changes - [2011-04-01]
- Notice to Stakeholders - Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
- Guide to Recalls of Medical Devices (GUI-0054) [2011-03-25]
- Guidance on Investigation of Reported Medical Device Problems (GUI-0065)
- Human Cells, Tissues and Organs for Transplantation - Error or Accident Investigation Preliminary Report From (FRM-0172) [2011-03-04]
- Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001) [2011-03-04]
- Letter [2011-03-04]
- Quality System Framework 2011 [2011-02-21]
- Guidance Document - Application for a Certificate of a Pharmaceutical Product (GUI-0024) [2011-02-04]
- Guidance Document - Guidelines for Temperature Control of Drug Products during Storage and Transporation (GUI-0069) [2011-01-28]
- Summary Report: Stakeholder Consultations on the Good Manufacturing Practices (GMP) Inspection Program Review [2011-01-26]
- User Problem Reporting for Medical Devices (GUI-0060): [2011-01-14]
