Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Therapeutic Goods Guidelines Multi Site Licences Instrument 2020
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Therapeutic Goods Information Relating Shortages AND Discontinuations Supply Medicines Specification 2018
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Therapeutic Goods Information Specification Medicine Shortages AND Availability Data Instrument 2024
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Therapeutic Goods Information Specification Therapeutic Vaping Goods AND Vaping Devices Instrument 2023
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Therapeutic Goods Listed Medicines Compliance Reviews Specification 2019
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Therapeutic Goods Medical Device Standard Therapeutic Vaping Devices Order 2023
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Therapeutic Goods Medical Devices Authorised Supply Rules 2022
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Therapeutic Goods Medical Devices Specified Articles Instrument 2020
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Therapeutic Goods Medical Devices Specified Articles Amendment Vaping Instrument 2023
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Therapeutic Goods Medicinal Cannabis Products Approvals AND Authorities Information Specification 2021
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Therapeutic Goods Medicinal Cannabis Products Information Specification 2021
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Therapeutic Goods Medicines AND Biologicals Ingredients AND Components Information Specification 2020
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Therapeutic Goods Medicines AND OTG Authorised Supply Rules 2022
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Therapeutic Goods Medicines Watch List Determination 2018
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Therapeutic Goods Medicines Authorised Supply Amendment Vaping Rules 2023
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Therapeutic Goods Medicines Standard Serialisation AND Data Matrix Codes TGO 106 Order 2021
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Therapeutic Goods Minamata Convention Information Specification 2022
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Therapeutic Goods OTC Medicines Information Must Accompany Application Registration Determination August 2018
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Therapeutic Goods Permissible Ingredients Determination
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Therapeutic Goods Prescription Medicines Information Accompanying Applications Registration Determination 2021
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Therapeutic Goods Prescription Medicines Kind Information Must Accompany Application Registration Determination 2022
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Therapeutic Goods Prescription Medicines Sharing Auspars Information Specification 2023
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Therapeutic Goods Prescription Medicines Transparency Measures Specification 2020
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Therapeutic Goods Reportable Medicines Determination 2025
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Therapeutic Goods Restricted Medicines Specification 2021
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Therapeutic Goods Serious Scarcity AND Substitutable Medicine Abatacept Instrument 2024
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Therapeutic Goods Serious Scarcity AND Substitutable Medicine Fluoxetine Amendment Instrument 2024
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Therapeutic Goods Serious Scarcity AND Substitutable Medicine Gliclazide Instrument 2024
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Therapeutic Goods Standard Biologicals Labelling Requirements TGO 107 Order 2021
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Therapeutic Goods Standard Nicotine Vaping Products TGO 110 Amendment Vaping Order 2023
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Therapeutic Goods Information Specification Database Recalls Product Alerts AND Product Corrections Instrument 2025
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Therapeutic Goods Therapeutic Goods Advertising Code Amendment 2022 Measures NO 1 Instrument 2022
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Therapeutic Goods Transition EU Medical Devices Regulation Information Specification 2022
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Therapeutic Goods Amendment 2009 Measures NO 2 ACT 2009
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Therapeutic Goods Amendment 2010 Measures NO 1 ACT 2010
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Therapeutic Goods Amendment 2016 Measures NO 1 ACT 2017
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Therapeutic Goods Amendment Repeal Ministerial Responsibility Approval Ru486 ACT 2006
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Therapeutic Goods Amendment Therapeutic Goods Advertising Code Instrument NO 4 2021
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Therapeutic Goods Amendment Therapeutic Goods Advertising Code Instrument 2019
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Therapeutic Goods Amendment ACT NO 3 2000
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Therapeutic Goods Information Exemptions Annual Charges Specification 2016
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Therapeutic Goods Information Medical Devices Specification 2017
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Therapeutic Goods Information Sharing Information About House Vitro Diagnostic Medical Devices Specification 2017
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Therapeutic Goods Information Specification 2017
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Therapeutic Goods Legislation Amendment 2024 Measures NO 2 Regulations 2024
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Therapeutic Goods Legislation Amendment Fees AND Other Measures Regulations 2024
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Therapeutic Goods Legislation Amendment Vaping Regulations 2023
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Therapeutic Goods Order NO 70C Standards Export Only Medicine
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Therapeutic Goods Order NO 94 Standard Haematopoietic Progenitor Cells Derived Cord Blood 2017
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Therapeutic Goods Medical Devices Excluded Purposes Specification 2022
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Competition AND Consumer ACT 2010
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Therapeutic Goods Medical Devices Donor Screening Covid 19 Emergency Exemption 2023
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Therapeutic Goods Articles ARE NOT Medical Devices Declaration 2023
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Therapeutic Goods Excluded Goods Hand Sanitisers Determination 2020
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Therapeutic Goods Declared Goods Order 2019
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Freedom Information ACT 1982
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Privacy ACT 1988
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Crimes ACT 1914
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Trade Marks ACT 1995
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Medical Device Standards Order Endotoxin Requirements Medical Devices 2018
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Australia NEW Zealand Food Standards Code Standard 294 Formulated Supplementary Sports Foods
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National Health AND Medical Research Council ACT 1992
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Therapeutic Goods Medical Devices Excluded Purposes Specification 2020
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Therapeutic Goods Microbiological Standards Medicines TGO 100 Order 2018
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Therapeutic Goods Standard Tampons TGO 103 Order 2019
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Therapeutic Goods Standard Menstrual Cups TGO 99 Order 2018
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Gene Technology ACT 2000
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Administrative Review Tribunal ACT 2024
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Customs Prohibited Imports Vaping Goods Approval 2023
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Therapeutic Goods Legislation Amendment Standard Therapeutic Vaping Goods TGO 110 Instrument 2024
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Therapeutic Goods Standard Mdma TGO 112 Order 2024
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Therapeutic Goods Standard Psilocybine TGO 113 Order 2024
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Therapeutic Goods Medical Device Standard Therapeutic Vaping Devices Amendment Order 2024
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Industrial Chemicals ACT 2019
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Consumer Goods Cosmetics Information Standard 2020
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Therapeutic Goods Vaping Goods Advertising Authorisation 2024
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Therapeutic Goods Standard Tablets Capsules AND Pills TGO 101 Order 2019
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Therapeutic Goods Classes Therapeutic Goods Instrument 2018
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Therapeutic Goods Charges ACT 1989
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Therapeutic Goods Legislation Amendment Australian Unique Device Identification Database AND Other Measures Regulations 2025
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Therapeutic Goods ACT 1989
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Therapeutic Goods Manufacturing Principles Determination 2020
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Therapeutic Goods Standard Human Cell AND Tissue Products Donor Screening Requirements TGO 108 Order 2021
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Therapeutic Goods Exempt Monographs Determination 2021
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Therapeutic Goods Exempt Monographs Amendment Determination 2025
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Therapeutic Goods Amendment 2022 Measures NO 1 ACT 2023
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Therapeutic Goods Standard Export Only Medicines TGO 114 Order 2024
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About Transvaginal Surgical Mesh Devices
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Australian Transvaginal Surgical Mesh Regulatory Actions
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Support Transvaginal Surgical Mesh Patients
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Resources Health Professionals About Transvaginal Surgical Mesh
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Improving Ethics Healthcare Delivery
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Australian Regulatory Actions Breast Implants
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International Regulatory Actions Breast Implants
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Risks
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Getting Help
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Breast Implant Associated Cancer
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Compliance Actions AND Outcomes
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Compliance Management Enforcement
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Report Breach
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Whats MY Medicine Label
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TGA Business Services Forms
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What WE Regulate
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HOW WE Regulate
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OUR Regulatory Framework
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Treatment Your Information
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About Work TGA Risk Management Approach
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What NOT Regulated US
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Leadership AND Business Divisions
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TGA Laboratories
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Testing Therapeutic Goods
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Laboratories Branch International Affiliations
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Corporate Plans AND Reports
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TGA Reforms
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Freedom Information FOI
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Information Publication Scheme
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FOI Disclosure LOG
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2011 JUN 2012
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2012 JUN 2013
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Accessing Documents OUR Website
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Copyright
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Privacy
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Disclaimer
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Security
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Contact US
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TGA Customer Service Standards
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Translate Website
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University Student Educational Materials
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Good Manufacturing Practice
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Introduction TGA
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Medicines Educational Materials
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Postmarket Monitoring
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Court Action
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Medical Device AND IVD Cancellations Artg
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Compliance Undertaking
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TGA Statutory Advisory Committees
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Careers
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Recruitment Information
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Fees AND Payments Links
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Summary Fees AND Charges Applications Submitted TGA
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Information AND Notices About TGA Fees AND Payments
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Cancellation Therapeutic Good NON Payment Annual Charge
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Information About Failure PAY Annual Charges Regulatory Actions
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Important Annual Charge Deadlines
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Annual Charges Therapeutic Goods
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Annual Charges Manufacturing Licences
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LOW Turnover Manufacturers
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Revoking Manufacturing Licences NOT Paying Annual Charge
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Refunds
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Cost Recovery Implementation Statements
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Forms Fees AND Payments
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Payment Options
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TGA Business Services Databases
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Picmi Search Facility
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International Engagements
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International Pharmaceutical Regulators Programme Iprp
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International Medical Device Regulators Forum Imdrf
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Australia Canada Singapore Switzerland United Kingdom Access Consortium
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Pilot Generic Medicines Work Sharing Program
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International Collaboration Highlights
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Medical Device Single Audit Program
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Medicines Safety AND General Information Consumers
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What ARE Therapeutic Goods
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Consumer Medicine Information CMI
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Safe Disposal Unwanted Medicines
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Importing Medicine OR Medical Device
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Personal Importation Scheme
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Counterfeit Fake Medicines AND Medical Devices
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Travelling Medicines AND Medical Devices
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Entering Australia
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Leaving Australia
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General Information AND Education Health Professionals
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Role TGA
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Medicines
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Product Information PI
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Prescribing Medicines Pregnancy Database
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Australian Categorisation System Prescribing Medicines Pregnancy
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Therapeutic Goods Exempted Pregnancy Categorisation
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Obstetric Drug Information Services
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Other Resources
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Regulation Basics
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HOW Therapeutic Goods ARE Regulated Australia
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Overview Supplying Therapeutic Goods Australia
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Role Sponsor
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Medicines AND TGA Classifications
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Registered Medicines
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Product Regulation According Risk
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Searching Australian Register Therapeutic Goods Artg
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Summary Supplying Therapeutic Goods Australia
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Legislation AND Legislative Instruments
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About Australian Therapeutic Goods Legislation
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Excluded Goods Orders Determinations AND Specifications
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Therapeutic Goods Groups Orders
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Manufacturing Principles AND Guidelines
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Medical Device Notices AND Standards Orders
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Declared Goods Orders
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Pharmacopoeias
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Product Information
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Therapeutic Goods Determinations
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Specifications