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Search our Australian Register of Therapeutic Goods (ARTG). Find ARTG cancellations and suspensions.
Australian Register of Therapeutic Goods, and cancellations and suspensions
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Australian Register of Therapeutic Goods (ARTG)
Search our database of therapeutic goods that can be supplied in Australia. -
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Cancellations for failure to pay annual charges
Find products removed from the ARTG after annual charges were not paid. -
Face mask cancellations
Search our database of face mask cancellations from the ARTG, based on results from our post-market review.
Safety
Get access to our safety alerts, actions and updates for medicines, medical devices (including IVDs) and biological products. Find out about market actions including recalls, product corrections and product alerts.
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Safety alerts
Refer to the latest safety alerts for medicines or medical devices with possible risks. -
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Safety updates
Refer to our articles for health professionals about health products and emerging safety issues. -
Database of Adverse Event Notifications (DAEN)
All adverse events reported to us are added to this searchable database. -
Alerts
See and search our full list of safety and medicine shortage alerts and market actions (including recalls, product alerts and product corrections).
Shortages
Search current medicine shortage alerts and reports. Refer to the Section 19A database lists for unregistered medicines approved for import due to shortages and public health needs.
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Medicine shortage reports database
Find information about medicine shortage reports and management actions, including the supply of overseas alternative medicines. -
Search the Section 19A approvals database
Search approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages.
Prescription medicine evaluations and decisions
Search our databases for prescription medicines under application, review and evaluation for registration. Find decisions on prescription medicine registrations by searching our decision summaries and report databases.
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Prescription medicine determinations and designations
View prescription medicines eligible for orphan drug status, registration via priority review or provisional approval. -
Prescription medicines under evaluation
Search applications for new medicines, or new uses for existing medicines, that are under current evaluation. -
Prescription medicines registrations
Search registrations for new medicines including generic medicines, chemical and biological entities (NCE and NBE), biosimilar medicines, biologicals and combinations. This includes extensions of indications, which describes new uses of medicines. -
Australian prescription medicine decision summaries
Use this database to find Australian prescription medicine decision summaries. -
Australian Public Assessment Reports (AusPAR)
Search our AusPAR dataset for information about evaluations of prescription medicines.
Exemptions, permissions and approvals
Search our databases for exemptions, permissions and approvals for therapeutic goods in Australia.
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Annual charge exemptions (ACE) dataset
View annual charge exemptions (ACE) based on a sponsor declaring $0 turnover. -
Search the Section 19A approvals database
Search approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages. -
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Section 14 consents
Refer to our database of consents to import, supply or export therapeutic goods that do not comply with standards. -
Section 14, TGO91 consents
Refer to our database of consents to import, supply or export therapeutic goods that do not comply with TGO 91 due to COVID-19. -
Companion Diagnostics (CDx) list
View the TGA’s list of approved companion diagnostics (CDx) in Australia, including details on in vitro diagnostic devices linked to specific medicines.
Notices
Access regulatory decisions, infringement notices, and advertising directions or prevention notices to ensure compliance with requirements.
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Regulatory decision notices
Access official regulatory decisions for sponsors, manufacturers and advertisers, including GMP clearances, listing notices, administrative instruments, and updates to regulatory requirements. -
Infringement notices
Search for infringement notices whereby a financial penalty may be issued in response to certain breaches of the Therapeutic Goods Act 1989 (the Act). -
Advertising directions and prevention notices
Find direction and prevention notices issued to advertisers and learn how we use them to stop non-compliant advertising. -
Face mask non-compliance notices
Search masks that need variations to their ARTG entry, for corrections or to meet labelling requirements.
Regulatory compliance and actions
Find the latest information on regulatory and compliance undertakings, decisions, actions and results.
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Advertising investigation outcomes
Report or view outcomes of investigations into potentially non-compliant advertising. -
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Court action
Read about court actions. It is our practice to publish details of regulatory compliance decisions and actions on our website. -
Face mask market actions
Search our post-market reviews for the quality and effectiveness of face masks in the ARTG. See market action we have taken, including product defect alerts and recalls. -
Listed medicine compliance reports
Read our results and outcomes of listed medicine compliance reviews.
Laboratory reports and reviews
View results of tests conducted by our Laboratories Branch.
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TGA laboratory testing reports
View our detailed results of tests by the Laboratories Branch for health products on our register.
Reference information for applications
Access eBusiness Services to check ingredient and indication requirements, view manufacturer details, and find codes and certificates. Search for sponsor information and legislation.
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Searching ingredient requirements
Check the requirements and restrictions associated with the use of each ingredient in your therapeutic good. -
Indications for listed medicines
Search indications that can be used in listed medicines, including information on the requirements for using specific indications. -
Australian manufacturer search
A list of Australian manufacturers that hold a current TGA manufacturing licence. -
Conformity Assessment certificate search
Search Conformity Assessment (CA) certificates that we issue to manufacturers of medical devices. -
Code tables
Search the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance. -
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Legislation
Find listed information for the legislation that is referred to in our Guidance content.
Acronyms and glossary
Search our list of acronyms and glossary terms. Find approved terminology for herbal ingredient plant parts and preparations.
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Acronyms and glossary terms
View terms and acronyms commonly used in Australian therapeutic goods regulation, and their definitions. This list is intended for general informational purposes and is not exhaustive. -
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COVID-19 product lists and databases
Explore COVID-19 databases, for information on, test kits, disinfectants, ventilators, face masks, vaccine safety reports and consents.
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COVID-19 test kits
Search COVID‑19 test kits approved for supply in Australia, including ARTG‑listed rapid antigen and laboratory tests. -
COVID-19 disinfectants
Search disinfectants claiming to be effective against the virus that causes COVID-19. -
COVID-19 ventilators
Search ventilators permitted for supply under the COVID-19 Emergency Exemption April 2020 to January 2021. -
Face mask market actions
Search our post-market reviews for the quality and effectiveness of face masks in the ARTG. See market action we have taken, including product defect alerts and recalls. -
Face mask non-compliance notices
Search masks that need variations to their ARTG entry, for corrections or to meet labelling requirements. -
Face mask cancellations
Search our database of face mask cancellations from the ARTG, based on results from our post-market review. -
COVID-19 vaccine safety reports
Read the latest update on the side effects reported for the COVID-19 vaccines. -
Section 14, TGO91 consents
Refer to our database of consents to import, supply or export therapeutic goods that do not comply with TGO 91 due to COVID-19.