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Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe Therapeutic Goods Administration (TGA) Australian Government Department of Health Main menu Home Safety informationReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Report an issue with packaging or storage of a medicine AEMS guidance for health professionals AEMS guidance for sponsors Help us promote adverse event reporting: promotional resources kit AlertsCurrent year alerts All alerts RecallsAbout Australian recall actions Recall actions database Uniform recall procedure Prescription opioids Medicine shortages Early warning systemMonitoring communications About the Early Warning System Early Warning System: consumer questions and answers Early Warning System: health professional questions and answers Black Triangle SchemeBlack Triangle Scheme: Information for sponsors Safety information & educationMedicines safety Medical devices safety Database of Adverse Event Notifications (DAEN) COVID-19 COVID-19 vaccinesCOVID-19 vaccine approval process COVID-19 vaccines undergoing evaluation Provisional registrations COVID-19 vaccine safety monitoring and reporting News and updates COVID-19 vaccine advertising and import compliance Information for consumers and health professionals Information for sponsors (industry) International collaboration International COVID-19 vaccines recognised by Australia COVID-19 treatmentsCOVID-19 treatment: Celltrion Healthcare Australia Pty Ltd, regdanvimab (REGKIRONA) COVID-19 treatment: Roche Products Pty Ltd, tocilizumab (ACTEMRA) COVID-19 treatments: Provisional determinations COVID-19 treatments: Provisional registrations COVID-19 treatments: Treatments undergoing evaluation COVID-19 treatments: Advertising compliance COVID-19 treatments: Information for consumers and health professionals COVID-19 treatments: Information for sponsors (industry) COVID-19 testsHow testing works for COVID-19 COVID-19 point-of-care tests COVID-19 rapid antigen self-tests COVID-19 rapid antigen tests - information for manufacturers and sponsors COVID-19 testing in Australia - information for health professionals Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests) Post market review of COVID-19 point-of-care tests ConsumersReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Travelling with medicines and medical devicesLeaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices onlineCounterfeit medicines and devices Can I import it?Personal importation scheme Medicinal cannabis: importation and the traveller's exemption MedicinesHow we regulate medicines Prescription medicines Complementary medicines Over-the-counter (OTC) medicines Vaccines What's on my medicine label? 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Codeine information hubFrom 1 February 2018, medicines that contain low-dose codeine will no longer be available without prescription in pharmacies. Labelling changes: information for health professionalsInformation for health professionals about changes to medicine labels. Medicines and TGA classificationsAustralia has a two-tiered system for the regulation of medicines, including complementary medicines. Product Information (PI)A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription, some non-prescription medicines and some biologicals. Safety information Availability of morphine sulfate injection products: Information for health professionalsAll strengths of DBL Morphine Sulfate Injection products are in limited supply due to manufacturing issues resulting in delays to packaging. Black Triangle SchemeThe Black Triangle Scheme provides a simple means for practitioners and patients to identify certain types of new prescription medicines, and to encourage the reporting of adverse events associated with their use. Cough and cold medicines for children - changesAdvice to consumers and health professionals on cough and cold medicines for children. Fast track approval pathways for prescription medicinesFast track approval aims to get prescription medicines that treat serious and life-threatening conditions to patients earlier. Pregnancy and medicines Prescribing medicines in pregnancy databaseThis database is intended to provide information to health professionals planning the medical management of pregnant patients or patients intending to become pregnant. It is not presented as medical advice to health professionals or the public. Registration of medicines for the medical termination of early pregnancyThe TGA has included Mifepristone (RU 486) on the Australian Register of Therapeutic Goods (ARTG) as of 29 August 2012. Medicine shortages Medicine Shortages Information InitiativeThe Medicine Shortages Information Initiative provides information about prescription medicine shortages in Australia. Accessing medicines during a medicines shortageThe TGA can approve the import and supply of a medicine that is not included in the ARTG under section 19A of the Act. The Therapeutic Goods Administration is part of the Health Products Regulation Group
The Therapeutic Goods Administration is part of the Health Products Regulation Group