Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Testing Medicinal Cannabis Products Being Supplied SAS Australia
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Aconitum Alkaloids Listed Medicines
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Testing Paediatric Medicinal Cannabis Products Being Supplied SAS Australia
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Testing Toxins Medicinal Cannabis Products Being Supplied SAS B Australia
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Testing Benzene Aerosol Sunscreen Products Being Supplied Australia
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Testing Vapes
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Review Regulation Head Lice Preparations Australia
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History Therapeutic Goods Regulation Australia
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Medical Devices Safety Update
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Medical Device Incident Reporting AND Investigation Scheme Iris Articles
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Reporting Medical Device Adverse Incidents
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TGA Approach Disclosure Commercially Confidential Information CCI
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ICH Guideline Good Clinical Practice
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OTC Application Placement Question AND Answer Tool
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Compositional Guidelines Finalised Prior MAY 2011
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TGA Conformity Assessment Overview Vitro Diagnostic Medical Devices
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USE Gmdn Codes IVD Medical Devices Australia
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Software Vitro Diagnostic Medical Devices Ivds
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Reduction Assessment Fees Medical Devices
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Australian Code Good Wholesaling Practice Medicines Schedules 2 3 4 8
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Guidelines Sterility Testing Therapeutic Goods
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Site Master File Preparation Pics Explanatory Notes Pharmaceutical Manufacturers
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S38 Guidelines Australian Manufacturing Licences Covering Multiple Manufacturing Sites
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Ncctg Scheduling Policy Framework
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Joint TGA Medicines Australia Guidelines Design AND Conduct Company Sponsored Post Marketing Surveillance Studies
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Ahmac Scheduling Policy Framework Medicines AND Chemicals 2015
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Performance Reports
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Economic Modelling AND Financial Quantification Regulatory Impact Proposed Changes Codeine Scheduling
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Regulation Impact Statement Codeine RE Scheduling
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Guidance USE Medicinal Cannabis Treatment Chronic NON Cancer Pain Australia
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Prescription Medicines AND Biologicals Annual Summaries
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TGA Stakeholder Surveys
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Completing Designation OR Determination Extension Application Form TGA Business Services
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TGA International Engagement Strategy Operations Plan 2018 19
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Half Yearly Performance Snapshot July December 2018
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Return Your Unused Opioids Resource KIT
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Help US Promote Adverse Event Reporting Promotional Resources KIT
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Australian Regulatory Guidelines Medical Devices Argmd V11 Archived Version
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Therapeutic Goods Advertising Compliance 2018 19 Annual Report
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Addressing Prescription Opioid USE AND Misuse Australia
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Health Products Regulation Group Regulatory Science Strategy 2020 2025
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Medicine Shortages Report First 12 Months Mandatory Reporting Scheme
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Half Yearly Performance Snapshot July December 2019
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Manufacturing Quality Branch Annual Reports
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Advice Health Procurement Teams About Therapeutic Goods AND Medical Devices
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TGA International Engagement Strategy 2021 2025
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Minocycline AND Agranulocytosis
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TGA International Engagement Strategy 2016 2020 Highlights AND Achievements Report
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Sglt2 Inhibitors Approved T2dm Only
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Literature Review Safety Titanium Dioxide AND Zinc Oxide Nanoparticles Sunscreens
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Regulation Impact Statement Reclassification HIP Knee AND Shoulder Joint Implants
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Veterinary Product Manufacturer Inspections
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Half Yearly Performance Reports
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International Coalition Medicines Regulatory Authorities Icmra
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Regulation Impact Statement General Requirements Labels Medicines
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Regulator Performance Framework Self Assessment Report July 2016 June 2017
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Prescription Medicines Registration NEW Chemical Entities Australia 2017
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Prescription Medicines AND Biologicals TGA Annual Summary 2017
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Prescription Medicines Registration NEW Generic Medicines AND Biosimilar Medicines 2017
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TGA Stakeholder Survey 2017
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Submissions Received Proposed Regulatory Changes Related Personalised AND 3D Printed Medical Devices
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TGA Nata MOU Relating Regulation House Ivds
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Medicines AND Vaccines Post Market Vigilance Statistics 2017
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Annual Performance Statistics Report July 2017 June 2018
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Australian Government Response Senate Community Affairs References Committee Report
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Faecal Microbiota Transplant FMT Outcomes FMT Stakeholder Forum
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TGA Stakeholder Survey 2018
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TGA Consumer Survey 2018
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Regulator Performance Framework Self Assessment Report July 2017 June 2018
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Regulatory Options Appropriate Access AND Safety Controls Alkyl Nitrites Public Meeting Questions AND Answers
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Medical Devices Reforms Action Plan Medical Devices
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Alkyl Nitrites Consultation
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Public Meeting Communique Regulatory Options Appropriate Access AND Safety Controls Alkyl Nitrites
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Pharmacovigilance Inspection Program Metrics Report September 2017 December 2018
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Acss Public Statement 14 15 MAY 2018
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Action Plan Medical Devices
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Acss Public Statement 29 30 October 2018
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Changes Labelling AND Regulation Hard Surface Disinfectants
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Submissions Received AND TGA Response Proposed Criteria Appendix M Poisons Standard Support Rescheduling Substances Schedule 4 Prescription Only Schedule 3 Pharmacist Only
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Submissions Received Proposal Introduce Unique Device Identification UDI System Medical Devices Australia
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TGA Actions Following 2018 Stakeholder Surveys
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Consumer Fact Sheet Recall Allergan Biocell Breast Implants
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Tabling Report Review 2016 Medicinal Cannabis Amendments Narcotic Drugs ACT 1967
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Submissions Received Options Regulation Faecal Microbiota Transplantation Materials
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Annual Performance Statistics Report July 2018 June 2019
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Submissions Received Proposed Reclassification Spinal Implantable Medical Devices
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Submissions Received Potential Reclassification Active Medical Devices Diagnosis AND Patient Therapy
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Submissions Received Proposed NEW Classification Rule Medical Devices Administer Medicines OR Biologicals Inhalation
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Submissions Proposed Changes Classification Heart AND Central Circulatorycns Contact Devices
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Submissions Received Proposed Changes Classification Active Implantable Medical Devices AND Their Accessories
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Submissions Received Regulation Software Including Software Medical Device
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Submissions Received Proposed Regulatory Scheme Personalised Medical Devices Including 3D Printed Devices
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Submissions Received Proposed Clarification Goods ARE Therapeutic Goods Goods Containing Folate Substances Certain Circumstances
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Submissions Received Proposed NEW Medical Device Classification Substances Introduced Body Body Orifice OR Applied Skin
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Submissions Received Changes Number Definitions AND Scope Medical Device Regulatory Framework Australia
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Safety Review Coumarin Topical Listed Medicines
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Australian Government Response Senate Community Affairs References Committee Progress Report
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Regulator Performance Framework Self Assessment Report July 2018 June 2019
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Outcomes Lower Risk Registered Over Counter OTC Products Review Pilot Project
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Pharmacovigilance Inspection Program Metrics Report January December 2019
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TGA Stakeholder Survey 2019
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Australian Government Response Review Reforms Therapeutic Goods Advertising Framework
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Outcomes LOW Negligible Risk Changes Permissible Ingredients 2020 2021
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Progress Update Improving Post Market Monitoring AND Surveillance Medical Devices
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TGA Stakeholder Survey 2020
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Medical Devices Consumer Working Group Meeting 1
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Medical Devices Consumer Working Group Meeting 2
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Medical Devices Consumer Working Group Meeting 3
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Medical Devices Consumer Working Group Meeting 4
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Points Consider Strain Changes Authorised Covid 19 Vaccines Ongoing Sars COV 2 Pandemic
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Australian Dental Sector Working Group Meeting 1
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Pharmacovigilance Inspection Program Metrics Report January December 2020
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Therapeutic Goods Import Advertising AND Supply Compliance Education Strategy
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2020 JUN 2021
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Independent Expert Panel Mdma AND Psilocybin
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Australian Dental Sector Working Group Meeting 2
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Submissions Received Proposed Refinements Regulation Personalised Medical Devices
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Final Report Australian Government Response Recommendations Senate Community Affairs References Committee Report
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Submissions Received Proposal Clarifying Regulation Residual Activity Claims Disinfectants
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Medical Devices Consumer Working Group Meeting 5
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Medical Devices Consumer Working Group Meeting 6
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Australian Dental Sector Working Group Meeting 3
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ACB Meeting Statement Meeting 2 18 April 2013
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ACB Meeting Statement Meeting 3 19 September 2013
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Accm Extracted Ratified Minutes Meeting 5 4 March 2011
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Accm Extracted Ratified Minutes Meeting 6 3 June 2011
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Accm Extracted Ratified Minutes Meeting 7 2 September 2011
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Accm Extracted Ratified Minutes Meeting 8 9 December 2011
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Accm Extracted Ratified Minutes Meeting 9 9 March 2012
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Accm Extracted Ratified Minutes Meeting 10 1 June 2012
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Accm Extracted Ratified Minutes Meeting 1 5 March 2010
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Accm Extracted Ratified Minutes Meeting 2 4 June 2010
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Accm Extracted Ratified Minutes Meeting 3 3 September 2010
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Accm Extracted Ratified Minutes Meeting 4 3 December 2010
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Accm Meeting Statement Meeting 11 7 September 2012
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Accm Meeting Statement Meeting 12 7 December 2012
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Accm Meeting Statement Meeting 13 1 March 2013
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Accm Meeting Statement Meeting 14 2 August 2013
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Accm Meeting Statement Meeting 15 6 December 2013
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Accm Meeting Statement Meeting 16 6 June 2014
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Advisory Committee Medical Devices 20102 Meeting Report AND Resolutions
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Advisory Committee Medical Devices 20103 Meeting Report AND Resolutions
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Advisory Committee Medical Devices Meeting 20111
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Advisory Committee Medical Devices 20113 Meeting Report AND Resolutions
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Advisory Committee Medical Devices Meeting 20121 Resolutions
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Advisory Committee Medical Devices Meeting 12
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Advisory Committee Medical Devices Meeting 13
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Advisory Committee Medical Devices Meeting 14
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Advisory Committee Medical Devices Meeting 15
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Acnm Meeting Statement 7 March 2013
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Acnm Meeting Statement 6 March 2014
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Acmd Advice Hepatitis C AND Human Immunodeficiency Virus Point Care Tests
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Acpm 268th Meeting Recommendations 4 5 February 2010
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Acpm 269th Meeting Recommendations 8 9 April 2010
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Acpm 270th Meeting Recommendations 3 4 June 2010
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Acpm Meeting Statement Meeting 288 1 February 2013
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Acpm Meeting Statement Meeting 289 1 March 2013
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Acpm Meeting Statement Meeting 290 5 April 2013
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Acpm Meeting Statement Meeting 291 6 7 June 2013
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Acpm Meeting Statement Meeting 292 1 2 August 2013
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Acpm Meeting Statement Meeting 293 21 August 2013
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Acpm Meeting Statement Meeting 294 3 4 October 2013
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Acpm Meeting Statement Meeting 295 5 6 December 2013
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TGC Meeting Statement Meeting 39 27 August 2013
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TGC Meeting Statement Meeting 40 20 June 2014
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TGC Meeting 19 8 November 2001
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TGC Meeting 20 16 April 2002
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TGC Meeting 21 11 February 2003
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TGC Meeting 22 11 August 2003
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TGC Meeting 23 17 December 2003
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TGC Meeting 24 4 MAY 2004
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TGC Meeting 25 7 September 2004
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TGC Meeting 26 24 November 2004
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TGC OUT Session Meeting February 2004
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TGC Meeting 27 9 June 2005
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TGC OUT Session Meeting April 2005
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TGC Meeting 28 24 January 2006
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TGC Meeting 29 7 September 2006
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TGC OUT Session Meeting April 2006
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TGC Meeting 30 3 MAY 2007
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TGC Meeting 31 29 November 2007
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TGC Meeting 32 29 April 2008
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TGC Meeting 33 15 16 October 2008
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TGC OUT Session Meeting February 2008
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TGC Meeting 34 13 MAY 2009
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TGC Meeting 35 14 October 2009
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TGC OUT Session Meeting March 2009
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TGC Meeting 36 11 August 2010
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TGC Meeting 37 6 April 2011
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Australian Therapeutic Goods Advisory Council Meeting Statement Meeting 1 22 November 2012
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Australian Therapeutic Goods Advisory Council Meeting Statement Meeting 2 5 February 2013
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Australian Therapeutic Goods Advisory Council Meeting Statement Meeting 3 6 August 2013
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Australian Therapeutic Goods Advisory Council Meeting Statement Meeting 4 4 February 2014
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ACB Meeting Statement Meeting 4 24 July 2014
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Acpm Meeting Statement Meeting 296 12 13 February 2014
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Acpm Meeting Statement Meeting 297 4 April 2014
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Acpm Meeting Statement Meeting 298 6 June 2014
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Acpm Meeting Statement Meeting 299 1 August 2014
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Acpm Meeting Statement Meeting 300 3 October 2014
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ACB Meeting Statement Meeting 5 25 September 2014