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ARTG cancellations and suspensions
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Cancellations by sponsors
Search our database of sponsor-requested cancellations from the Australian Register of Therapeutic Goods (ARTG). -
Cancellations for failure to pay annual charges
Find products removed from the Australian Register of Therapeutic Goods (ARTG) after annual charges were not paid. -
Face mask cancellations
Search our database of face mask cancellations from the Australian Register of Therapeutic Goods, resulting from our post-market review.
Safety
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Safety alerts
Read about safety problems reported for medicines and medical devices, and any actions you need to take. -
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Safety updates
Stay informed as a health professional on safety issues and changes to product information for medicines and medical devices. -
Database of Adverse Event Notifications (DAEN)
Use the DAEN to find information about adverse events or side effects reported to us. -
Alerts
See and search our full list of safety and medicine shortage alerts and market actions (including recalls, product alerts and product corrections).
Shortages
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Medicine shortage alerts
Find information about medicine shortages, how long we expect them to last and available alternatives. -
Medicine shortage reports database
Search medicine shortage reports. Find information about 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 ARTG to address medicine shortages.
Prescription medicine evaluations and decisions
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Prescription medicine determinations and designations
Prescription medicines eligible for orphan drug status, or for registration via priority review or provisional approval. -
Prescription medicines under evaluation
These applications for new medicines or new uses for existing medicines are under evaluation by the TGA. -
Prescription medicines registrations
Search registrations for new medicines including generic medicines, chemical and biological entities (NCE and NBE), biosimilar medicines, biologicals and combinations. You can also search extensions of indications, which describes new uses of medicines. -
Australian prescription medicine decision summaries
Search our Australian prescription medicine decision summary database. -
Exemptions, permissions and approvals
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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 ARTG to address medicine shortages. -
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Section 14 consents
Database of consents to import, supply or export therapeutic goods that do not comply with standards. -
Section 14, TGO91 consents
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
Search companion diagnostics (CDx) we have approved for supply in Australia.
Business applications
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TGA Business Services (TBS)
Set up your TGA Business Services account and manage applications and ARTG entries. -
Notices
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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. -
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Advertising directions and prevention notices
Find direction and prevention notices and learn how we use them to stop non-compliant advertising. -
Face mask non-compliance notices
Search masks that need variations to their Australian Register of Therapeutic Goods (ARTG) entry, for corrections or to meet labelling requirements.
Regulatory compliance and actions
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Advertising investigation outcomes
Find out how to report potentially unlawful advertising, our enforcement options for taking action to manage non-compliance and outcomes from the actions we take. -
Compliance undertakings
View the latest formal agreements between individuals or companies and the Department of Health, Disability and Ageing made in place of legal action. -
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Face mask market actions
Search our post-market reviews on face masks in the Australia Register of Therapeutic Goods, for quality and effectiveness. See market action we have taken, including product defect alerts and recalls. -
Listed medicine compliance reports
Results and outcomes of the TGA’s listed medicine compliance reviews.
TGA laboratory reports and reviews
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TGA laboratory testing reports
The detailed results of tests by the Laboratories Branch for health products on our register.
COVID-19 product lists and databases
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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 on face masks in the Australia Register of Therapeutic Goods, for quality and effectiveness. See market action we have taken, including product defect alerts and recalls. -
Face mask non-compliance notices
Search masks that need variations to their Australian Register of Therapeutic Goods (ARTG) entry, for corrections or to meet labelling requirements. -
Face mask cancellations
Search our database of face mask cancellations from the Australian Register of Therapeutic Goods, resulting 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
Database of consents to import, supply or export therapeutic goods that do not comply with TGO 91 due to COVID-19.
Reference information for applications
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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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Acronyms and glossary
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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.