Regulator resource library

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Advertising Consultations

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Manage Medicine Shortage

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Application Process Prescription Medicines

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PRE Submission Planning Prescription Medicines

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Submit Your Application AND Dossier

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TGA Evaluation

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Your Ongoing Responsibilities

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Vary Your Artg Entry Prescription Medicine

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Reforms Regulation Prescription Medicines

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Apply Prescription Medicine Priority Review Pathway

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Apply Prescription Medicine Provisional Registration Pathway

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Apply Prescription Medicine Orphan Drug Designation

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Comparable Overseas Regulators

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Literature Based Submissions

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PRE Submission Planning Form

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Understand NON Prescription Medicine Pathways

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Check IF Your Health Product NON Prescription Medicine

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Ingredient Requirements NON Prescription Medicines

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Indication Requirements NON Prescription Medicines

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Manufacturing Requirements AND Standards NON Prescription Medicines

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Labelling AND Advertising NON Prescription Medicines

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Dossier Requirements NON Prescription Medicines

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Certifying Your Listed OR Assessed Listed Medicines Meet ALL Regulatory Requirements

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Managing Your NON Prescription Medicine AND TGA Account

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Vary Details Your NON Prescription Medicine Artg Entry

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Reforms Regulation NON Prescription Medicines

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Supply Biological

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Standards NON Prescription Medicines

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Assuring Safety AND Quality NON Prescription Medicines

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Comparable Overseas Bodies Cobs

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Biological Products Regulated Therapeutic Good NOT Biological

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Biological Products ARE Exempt OR Excluded TGA Regulation

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Specific Types Medical Devices

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What Kind Medical Device IT

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Regulated Biological

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Prepare Medical Device Application Audit

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Understand Medical Device Labelling Requirements

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Vary Medical Device Entries Artg Includes Ivds

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Medical Devices Reforms

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Post Market Monitoring

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Past Compliance Reviews

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Submit Your Application AND Dossier Biologicals

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Applicable Standards Biologicals

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Forms Biological Industry

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Your Ongoing Responsibilities

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Vary Your Artg Entry Biological

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Supply Other Therapeutic Goods

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Disinfectants AND Sterilants

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Confirm Your Product Regulated Biological

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Manufacture Medicine

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Good Manufacturing Practice GMP

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Make Statutory Declaration

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Release Medicine Supply

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Manufacturer Inspections

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Comply State Territory AND Other Requirements

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Record Keeping Requirements Manufacturers Medicines

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Overseas Manufacturers

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Australian Manufacturers

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Vary Your GMP Clearance OR Licence

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Complying Pics Guide Good Manufacturing Practice Medicinal Products

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Medicines AND Biologicals Labelling AND Packaging

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Advertising Considerations

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Medical Devices Labelling AND Information

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Labelling Requirements International Harmonisation Ingredient Names Project

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Standards Labels AND Packaging

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Required Advisory Statements Medicine Labels Rasml

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Permitted Indications Determination

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Code Practice Tamper Evident Packaging

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Summary Fees AND Charges

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Annual Charges

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Annual Charge Exemption Scheme Therapeutic Goods

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Cancellation Artg Entry DUE NON Payment Annual Charge

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Annual Charges Manufacturing Licence

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Revocation Manufacturing Licence DUE NON Payment

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Online Payment Portal

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Poisons Standard AND Scheduling Medicines AND Chemicals

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Permissible Ingredients Determination

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Herbal Ingredients

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Amending Poisons Standard

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Import

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Export

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Black Triangle Scheme

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Obligations Report Adverse Event Medical Devices

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Reporting Medical Device Incidents Sponsors AND Manufacturers

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Obligations Report Adverse Events Medicines AND Biologicals

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Supplying Alternative Medicines During Shortage

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Report Medicine Shortage Industry

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Medicinal Cannabis Reforms Frequently Asked Questions

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Application Process Supplying Biological

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Standard Pathway

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PRE Submission Planning

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Obtain AND Maintain Regulatory Evidence

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Overseas Regulatory Evidence Options Medical Device Application

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Poisons Standard Susmp

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Acms Members

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Medical Device Inclusion Process

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Documents Support Your Medical Device Inclusion

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Confirm Your Product Needs BE Artg Medical Device

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Accs Members

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Joint Acms Accs Meetings

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ACM Members

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Accm Members

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ACB Members

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Advisory Committee Medical Devices Members

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ACV Members

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Aivc Members

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Submit Your Application Inclusion Medical Device

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Processing Your Application Inclusion Medical Device

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Print Artg Certificate Inclusion Your Medical Device

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Supply Medicine Under Special Circumstances

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Submitting Application TBS Class I NON Sterile NON Measuring AND Class 1 IVD Medical

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Submitting Application TBS ALL Classes Except Class I NON Sterile NON Measuring Medical

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Listed Medicines Containing Andrographis Paniculata Requiring Warning Statements

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About Australian Prescription Medicine Decision Summaries Auspmdss

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QAS Combination Rapid Antigen Self Tests

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Paracetamol Questions AND Answers

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Efficacy Medicines Containing Vitamin D USE Indications Relating Bone

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Medicinal Cannabis Authorised Prescriber Scheme Data

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Efficacy Lysine Hydrochloride Cold Sores

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Priority Review Pathway Biologicals

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EU MDR Transition

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Manufacturer Evidence

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Device Change Request AND Variations

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Conformity Assessment Essential Principles AND Consent Supply

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Recalls AND Market Notifications

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Online Assessment Tool AND Notification Form

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EU MDR Transition WEB Publication Service

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Update Poisons Standard Formatting AND Structure

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Advertising Ozempic AND GLP 1 Receptor Agonists Prohibited

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Five Questions ASK Your Health Professional YOU GET Medical Implant

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Major OR Ongoing Medicine Shortages

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Access Unapproved Therapeutic Good Health Practitioners

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Lists Products Established History USE

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Access Generic Medicines Work Sharing Initiative

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Pfizer Covid 19 Bivalent Comirnaty Originalomicron BA4 5 Covid 19 Vaccine Booster Dose Vaccine

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Covid 19 Vaccines 2023 Provisional Approvals

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RE Scheduling Psilocybin AND Mdma Poisons Standard Questions AND Answers

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Interim Decision Paracetamol Access Controls Poisons Standard Questions AND Answers

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Mdma AND Psilocybine HUB

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Special Access Scheme SAS Category C Lists

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Authorised Prescriber Established History USE Lists

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Supply Unapproved Therapeutic Good Sponsors

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Nitrosamine Impurities Medicines

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Information About Specific Safety Alerts AND Recalls

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Moderna Covid 19 Bivalent Spikevax Bivalent Originalomicron BA4 5 Booster Dose Vaccine

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About Pholcodine Cough Medicines Cancelled TGA AND Recalled Pharmacies Safety Reasons

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GMP Forum Program

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GET Touch US

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Medicinal Substances Medical Devices

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Medical Device Reforms Publicly Reporting Tgas Assessment Timeframes

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Medical Device Reforms Consumer Representation Expert Working Groups

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Medical Device Reforms Medical Devices Consumer Working Group

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Medical Device Reforms Womens Health Products Working Group

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Medical Device Reforms Improving Consumerpatient Information

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Medical Device Reforms Five Questions ASK YOU GET Medical Implant

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Dual Labelled Medicine Ingredient Names Transition Sole Names

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Understand Ingredient Names Medicine Labels They Transition Show NEW Names Only

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Buying Health Products Online HAS Risks

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Updating Medicine Ingredient Names Overview

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About UDI Australia

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EU MDR Transition Extension

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Post Market Review Home USE Foetal Dopplers

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Post Market Review Spinal Cord Stimulation Devices

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Post Market Review Ventilator Cpap AND Bipap Devices

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Medicines Repurposing Program Eligibility Criteria AND Application Process

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About Artg Search Visualisation Tool

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Covid 19 Home USE Tests

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Post Market Review HIV Nucleic Acid Tests

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NON Prescription Medicine Requirements AND Standards

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Self Paced Online Learning

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Online Education Events

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Person Events

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Education Partnerships

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Access Unapproved Products Consumers

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HOW WE ARE Managing Medical Device Supply Disruptions Resulting Changes Europe

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Compliance AND Education Listed Medicines

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List Ventilator Cpap AND Bipap Devices Containing PE PUR Foam Material Breathing GAS Pathway

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Identifying Medicines Long Term Shortage

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Registration Prescription Medicines Manage Shortages

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Biologicals

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Therapeutic Goods Amendment 2022 Measures NO 1 ACT 2023 March 2023

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Listed Medicines Containing Artemisia Species Requiring Warning Statements

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Established Acceptable Intake Nitrosamines Medicines

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Changes Product Information PI Package Insert Injectable Products

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Listed Medicines Containing Mollusc Derived Ingredients Requiring Warning Statements

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Quality Management AND Medical Devices

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Learn About Quality Management Systems

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Access Mdma OR Psilocybine Consumers

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Prescribe Mdma OR Psilocybine Psychiatrists

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Supply Manufacture OR Import Mdma OR Psilocybine Sponsors AND Manufacturers

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Dispense OR Compound Mdma AND Psilocybine Pharmacists

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SAS AND AP Online System Information

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Medical Devices Vigilance Program Pilot

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Medical Device Reforms Point Care Manufacturing Medical Devices

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Patient Implant Cards AND Information Leaflets

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Website Blocked

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Brexit Implications Therapeutic Goods Australia

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Post Market Review Medical Devices Containing Mercury

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Medical Device Post Market Review Process

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Manage Medical Device Supply Disruption