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Safety information

Links to safety information about therapeutic products

• Product recalls
  A product recall is the removal of a therapeutic good from supply on the Australian market for reasons relating to their quality, efficacy or safety
  • All recall actions
    Searchable database of recall actions agreed since 1 July 2012
  • Recalls from 2001 to 2013
    Links to certain published recall actions undertaken in Australia from 2001 to 20 Feb 2013
  • About recall actions
    Further information about recall actions
  • Overseas recalls
    Information about overseas recall actions
• Alerts
  Links to safety alerts and advisory statements about medicines and medical devices in Australia.
  • Current year alerts
    Links to alerts issued by the TGA during the current year.
  • All alerts
    Links to alerts issued by the TGA since 1998
  • About alerts
    Alerts provide important information and recommendations about therapeutic goods.
• Reporting problems
  The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices
  • Reporting medicine and vaccine adverse events
    What to report, how to report and what happens to reports of problems with medicines
  • Reporting medical device problems
    What to report, how to report and what happens to reports of problems with medical devices or in vitro devices
  • Report a medicine deficiency or defect
    This form is used to report deficiencies or defects of medicines, which may have arisen during manufacture, storage, or handling
• Safety information & education
  Links to advice and educational materials about the safety of therapeutic goods.
  • Medicines safety
    General information about the safety of medicines and how safety is monitored
  • Medical devices safety
    General information about the safety of medical devices and how safety is monitored
  • Database of Adverse Event Notifications
    Searchable database of adverse event reports received by the TGA

Consumers

Links to information for consumers about therapeutic goods, such as medicines and medical devices

• Consumer information & education
  Information for consumers, patients and carers about medicines and medical devices
  • Safety information for consumers
    The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.
  • Buying online or from overseas
    Products available on international websites are not regulated by the Therapeutic Goods Administration (TGA).
  • Medicines & medical devices
    General information for consumers about medicines and medical devices in Australia
  • Community Q&A
    The TGA often receives questions about such things as our role, or issues relating to medicines and medical devices and their use
  • Import & export of therapeutic goods
    Therapeutic goods imported into or taken out of Australia may be subject to controls even when they are intended for personal use or non-commercial purposes
  • Other web resources for consumers
    Links to other web resources for consumers
• Reporting problems
  What to report, how to report, what happens to reports
  • Reporting medicine and vaccine adverse events
    Report suspected adverse reactions to vaccines and prescription, over-the-counter and complementary medicines
  • Report a problem with a medical device
    Report medical device adverse incidents that involved actual harm or that could have resulted in harm to a patient, caregiver or other person
• For travellers & visitors
  Medicines brought into or taken out of Australia may be subject to import and/or export controls.
  • Leaving Australia
    Issues surrounding taking medicines or medical devices overseas can cause a great deal of stress for travellers
  • Entering Australia
    Medicines brought into and taken out of Australia may be subject to respective import and export controls

Health professionals

Links to information for health professionals about medicines and medical devices.

• Health professional information & education
  Information for health professionals about therapeutic goods.
  • Safety information for health professionals
    Links to information for health professionals about the safety of medicines and medical devices.
  • Medicines
    General information for health professionals about medicines in Australia
  • Medical devices
    General information for health professionals about medical devices in Australia
  • Other web resources for health professionals
    Links to other web resources for health professionals
• Reporting problems
  What to report, how to report and what happens to reports
  • Reporting medicine and vaccine adverse events
    The public, healthcare professionals and industry are encouraged to report problems with medicines or medical devices so that the TGA can identify and respond to safety matters
  • Report a problem with a medical device
    If a patient has experienced or you suspect they may be experiencing an adverse event relating to a medicine or medical device, report the adverse event to the TGA
• Accessing unapproved products
  There are a number of ways that patients can gain access to products that have not been approved for use in Australia.
  • Authorised prescribers
    The TGA is able to grant medical practitioners authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients
  • Special access scheme
    The Special Access Scheme refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis
  • Personal import scheme
    Describes how individuals can import unapproved therapeutic goods for personal use
  • Human Research Ethics Committees and the therapeutic goods legislation
    Describes the role of Human Research Ethics Committees (HRECs) in relation to the supply of unapproved therapeutic goods

Industry

Links to information about the regulation of therapeutic goods in Australia.

• Regulation basics
  How therapeutic goods are regulated in Australia
  • How therapeutic goods are regulated in Australia
    The regulation of therapeutic goods in Australia is designed to ensure the quality, safety, efficacy and performance of medicines and medical devices
  • Australian Register of Therapeutic Goods
    The Australian Register of Therapeutic Goods is a computer database of therapeutic goods. Therapeutic goods are divided broadly into two classes - medicines and medical devices.
  • Legislation & legislative instruments
    Information about and links to Australian therapeutic goods legislation
  • Advertising therapeutic goods
    Advertisements for therapeutic goods in Australia are subject to the requirements of the Therapeutic Goods Act and Regulations, the Trade Practices Act and other relevant laws.
  • Labelling & packaging
    Labelling and packaging is part of the Australian system of regulating medicines and medical devices
  • Import & export
    Information about importing and exporting therapeutic goods for commercial purposes
  • Clinical trials
    These documents describe the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial.
  • Cosmetics
    The TGA only assesses cosmetic products that make therapeutic claims
  • Safety information for industry
    The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries
• Prescription medicines
  How prescription medicines are regulated in Australia, including guidelines, standards, regulatory decisions and links to other resources
  • Prescription medicines regulation basics
    General information about how prescription medicines are regulated in Australia
  • Standards, guidelines & publications
    Standards, guidelines and publications about the regulation of prescription medicines
  • Forms for prescription medicine sponsors
    Links to forms for sponsors of prescription medicines
  • Regulatory decisions and notices
    Regulatory decisions and notices about prescription medicines regulation, e.g. AusPARs, notices for sponsors
• Over-the-counter medicines
  How over-the-counter (OTC) medicines are regulated, including guidelines, standards, regulatory decisions and links to other resources
  • OTC medicines regulation basics
    General information about how over-the-counter (OTC) medicines are regulated in Australia
  • Standards, guidelines & publications
    Standards, guidelines and publications about the regulation of OTC medicines
  • Forms for OTC medicine sponsors
    Links to forms for sponsors of OTC medicines
  • OTC medicines reforms
    The TGA and Medsafe have begun work on reforms to the over the counter (OTC) medicines business processes
  • Regulatory decisions & notices
    Links to regulatory decisions and notices about OTC medicines, e.g. advertising exemptions
• Complementary medicines
  How complementary medicines are regulated in Australia, including guidelines, standards, regulatory decisions and links to other resources
  • Complementary medicine regulation basics
    General information about how complementary medicines are regulated in Australia
  • Standards, guidelines & publications
    Guidance on the regulatory requirements for complementary medicines
  • Forms for complementary medicine sponsors
    Application forms for sponsors of complementary medicines
  • Complementary medicines reforms
    Progress and planned activity for complementary medicine reforms for 2012-2013
  • Regulatory decisions & notices
    Information for complementary medicine sponsors, manufacturers and consumers
• Sunscreens
  How sunscreens are regulated, including guidelines and standards
  • Sunscreens regulation basics
    General information about how sunscreens are regulated in Australia
  • Standards, guidelines & publications (sunscreens)
    Standards, guidelines and publications about the regulation of sunscreens
• Medical devices & IVDs
  How medical devices and in vitro diagnostic medical devices are regulated in Australia, including guidelines, standards, regulatory decisions and links to other resources
  • Medical devices regulation basics
    General information about how medical devices are regulated in Australia
  • IVD medical devices regulation basics
    General information about how in vitro diagnostic medical devices (IVDs) are regulated in Australia
  • Standards, guidelines & publications
    Standards, guidelines and publications about the regulation of medical devices and in vitro devices
  • Forms for medical device & IVD sponsors
    Links to forms for sponsors of medical devices and in vitro diagnostic medical devices
  • Medical devices reforms
    The TGA has begun work on a series of reforms to the regulation of medical devices
  • Regulatory decisions & notices
    Links to regulatory decisions about medical devices and in vitro devices, e.g. advertising exemptions
• Blood, tissues & biologicals
  How blood, tissues and biological products are regulated in Australia, including guidelines, standards, regulatory decisions and links to other resources
  • Blood & tissues regulation
    Information about the regulation of blood and tissues in Australia
  • Biologicals regulation
    General information about how biologicals are regulated in Australia
• Other therapeutic goods
  How 'other therapeutic goods' are regulated in Australia, including guidelines, standards, regulatory decisions and links to other resources
  • Disinfectants & sterilants
    Information about the regulation of sterilants and disinfectants in Australia
  • Tampons & menstrual cups
    Information about how tampons and menstrual cups are regulated in Australia
• Manufacturing therapeutic goods
  Information for manufacturers of therapeutic goods, including guidelines, standads and links to other resources
  • Manufacturing basics
    General information about how manufacturing of therapeutic goods is regulated in Australia
  • Manufacturing medicines
    Information for manufacturers of medicines
  • Manufacturing medical devices & IVDs
    Information for medical device and in vitro diagnostic medical devices manufacturers
  • Manufacturing blood, tissues & biologicals
    Information for manufacturers of blood, tissues and biological products
  • Manufacturing standards for overseas manufacturers
    Information for overseas manufacturers about the regulation of therapeutic goods in Australia
  • Forms for manufacturers
    Links to forms for manufacturers of therapeutic goods.
  • Notices for manufacturers
    Notices and advice for manufacturers of therapeutic goods
• Scheduling of medicines & poisons
  Scheduling is a national classification system that controls how medicines and poisons are made available to the public.
  • Scheduling basics
    What is scheduling of medicines and poisons, background and general information
  • The Poisons Standard (the SUSMP)
    The Poisons Standard consists of decisions regarding the classification of drugs and poisons into Schedules for inclusion in the relevant legislation of the States and Territories
  • Scheduling news
    Updates and news about scheduling medicines and poisons
  • Public notices about scheduling
    Public notices about scheduling medicines and chemicals, including delegate's decisions, updates and advisory committee notices.
  • State/Territory scheduling information
    State and Territory Governments classify the vast majority of drugs and poisons in accordance with the Poisons Standard.

About the TGA

The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

• TGA basics
  The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose.
  • Who we are & what we do
    The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods.
  • What the TGA doesn't do
    Information about what the TGA doesn't do
  • TGA structure
    The Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health and Ageing.
  • TGA plans & reports
    Links to TGA plans and reports, including annual reports, business plans, legal expenditure reports, records listings
  • Freedom of information
    The Freedom of Information Act 1982 is designed to give the Australian community access to information held by the Commonwealth Government.
  • TGA reforms
    The TGA is focusing on implementing changes to ensure a greater emphasis on transparency of regulatory decision-making processes, a continuing focus on business process reform and a more strategic approach to the use of information technology to support regulatory operations.
  • Acronyms & glossary
    A list of acronyms and glossary terms likely to be found within Therapeutic Goods Administration information.
  • Publications
    Links to TGA publications
  • Forms
    Links to TGA forms
  • Featured
    Links to featured items on this website
  • TGA Internet site
    Links to information about the TGA Internet site.
• Contact the TGA
  You can contact the TGA using the options below. Our main office is located in Symonston, ACT.
  • How can we help?
    Can't find the information you are after? Please ask us.
  • TGA customer service standards
    The TGA's overall purpose is to protect public health and safety by regulating therapeutic goods that are supplied either imported or manufactured, or exported from Australia.
  • Report a perceived breach or questionable practices
    Form for reporting a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
  • Website feedback or error reporting
    Use this form to provide comments or suggestions about this website or if you would like to advise us of errors, such as broken links
• Committees
  Definitions and links to information about Therapeutic Goods Administration committees
  • Statutory expert committees
    The TGA has nine statutory expert committees it may call upon to obtain independent advice on scientific and technical matters
  • Other committees
    Other therapeutic goods committees
• Employment & job vacancies
  If you want to join our team and can meet our job requirements, we invite you to apply for one of our positions.
  • Working for the TGA
    The TGA protects public health and safety by regulating medicines and medical devices manufactured, imported, supplied in and exported from Australia.
  • Recruitment information
    If you are interested in joining our team and can meet our job requirements, we invite you to apply for one of our positions
• Fees & payments
  The TGA is fully cost-recovered and collects its revenue primarily through annual charges, evaluation and assessment fees and licence fees.
  • Current fees
    Summary of fees and charges for the current financial year and explanatory notes
  • Invoices & payment of accounts
    Information about TGA invoices and paying your account
  • Information & notices about TGA fees & payments
    Information and notices about TGA fees and payments
  • Cost recovery impact statements
    The Therapeutic Goods Administration routinely prepares cost recovery impact statements
  • Forms
    Links to forms related to TGA fees and payments
• TGA eBusiness Services
  TGA eBusiness Services establishes a base for electronic commerce, electronic lodgement of data packages in support of applications for entry of products onto the Australian Register of Therapeutic Goods and enables online client access to legally appropriate information.
  • About TGA eBusiness Services
    TGA eBusiness Services is the TGA's platform for electronic commerce and lodgement of data packages in support of applications for entry of products onto the ARTG
  • eBusiness Services forms
    These forms are used by sponsors, agents and manufacturers to apply for access to TGA eBusiness Services
  • PI/CMI search facility
    The CMI is a leaflet about the safe and effective use of a medicine. The PI provides health professionals with a summary of essential scientific information about a medicine.
• International
  Information about the TGA's international activities and links to international organisations involved in the regulation of therapeutic goods.
  • International activities
    As an internationally-respected regulator, the TGA is involved in many activities with overseas organisations
  • International cooperation
    The TGA works closely with overseas regulatory agencies and has a number of agreements with them
  • Links to international agencies & organisations
    Links to websites of international agencies and organisations related to therapeutic goods regulation
• TGA Internet site archive
  The content in the TGA Internet site archive is provided to assist research and may contain references to activities or policies that have no current application
  • Archived committee information
    Links to archived information about therapeutic goods committees
  • Archived consultations & reviews
    Archived TGA consultation and review documents
  • Archived media releases
    Archived TGA media releases and statements
  • Archived regulatory decisions & notices
    Archived regulatory decisions & notices
  • Archived TGA publications & articles
    Archived TGA publications
  • Archived ANZTPA information
    Archived information about the Australia New Zealand Therapeutic Products Agency (ANZTPA)

News room

Links to news and updates about the regulation of therapeutic goods in Australia and activities of the TGA.

• News & public notices
  News, updates and public notices from the TGA.
  • Latest news & updates
    Latest news and updates from the Therapeutic Goods Administration
  • Media releases & statements
    TGA media releases and statements
  • Behind the news
    Overviews of issues relating to the TGA
  • Newsletters & articles
    Newsletters and articles produced by the TGA
  • Subscribe to updates
    The TGA has a number of email lists to which you can subscribe to receive updates by email
  • TGA tenders
    All publicly available tenders and business opportunities are advertised on the Australian Government Tender System (AusTender)
• Consultations & reviews
  The TGA has a range of consultative mechanisms in place in order to consult with industry, health professionals and consumers.
  • Open consultations & reviews
    Links to open TGA consultations and reviews
  • Closed consultations & reviews
    Links to closed TGA consultations and reviews
  • Consultation forecast
    List of upcoming TGA consultations and reviews
• Events, training & presentations
  Events & training related to the regulation of therapeutic goods, and copies of presentations given by the TGA at seminars and workshops.
  • Events & training
    Details of events and training related to the regulation of therapeutic goods in Australia
  • Presentations
    Links to copies of presentations given by TGA staff at events and training sessions