On this page: Safety information | Consumers | Health professionals | Industry | About the TGA | News room

Safety information

No therapeutic product is ever completely risk free. Some risks may be known when a medicine or medical device is first entered on the Australian Register of Therapeutic Goods (ARTG). However, some information only comes to light after more people use the products.

This section includes current and historic recalls of medicines and medical devices, advice that the TGA has issued about products, monitoring communications, information on reporting problems and how the safety of therapeutic products are monitored.

• Safety information
  • Reporting problems & complaints
    What you should report, how you can report it and what happens to your reports...
    • Reporting adverse events involving medicines, vaccines or medical devices
    • Report a side effect of a medicine
    • Report an issue with packaging or storage of a medicine
  • Alerts
    Important information and recommendations about therapeutic products...
    • Current year alerts
    • All alerts
  • Recalls
    Actions taken to resolve a problem with a therapeutic good already supplied in the market...
    • Recall actions database
    • Uniform recall procedure
  • Early warning system
    Information on safety concerns for medicines and medical devices...
    • Monitoring communications
    • About the Early Warning System
    • Early Warning System: consumer questions and answers
    • Early Warning System: health professional questions and answers
  • Black Triangle Scheme
    The 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...
    • Black Triangle Scheme: Information for sponsors
  • Safety information & education
    Safety information & advice about medicines and medical devices, including how the safety of products is monitored...
    • Medicines safety
    • Medical devices safety
    • Database of Adverse Event Notifications (DAEN)

Consumers

The information in this section is for patients, travellers, carers and members of the general public.

If you require medical advice please contact your GP, pharmacist or health provider.

• Consumers
  • Reporting problems
    What you should report, how you can report it and what happens to your reports
    • What you should report, how you can report it and what happens to your reports...
    • Report a side effect of a medicine
    • Report an issue with packaging or storage of a medicine
  • Can I import it?
    Information about bringing medicines and devices into Australia...
    • Personal importation scheme
    • Medicinal cannabis: importation and the traveller's exemption
  • Buying medicines and medical devices online
    Information on how to safely and lawfully buy medical products online...
    • Counterfeit medicines and devices
  • For travellers & visitors
    Information about how to travel into or out of Australia with medicines and medical devices...
    • Leaving Australia
    • Entering Australia
    • Helpful links for travellers
  • Consumer information & education
    Information about medicines and medical devices, including safety and general information...
    • Safety information for consumers
    • Consumer educational materials
    • Medicines & medical devices
    • Community Q&A
    • MedSearch | Medicine information search app
    • Other web resources for consumers

Health professionals

Do you use or prescribe therapeutic goods in a professional capacity?

The information in this section is for health providers, such as doctors, nurses, pharmacists, complementary practitioners, etc. It is not presented as medical advice to health professionals or the public.

• Health professionals
  • Reporting problems
    What you should report, how you can report it and what happens to your reports...
    • Reporting adverse events involving medicines, vaccines or medical devices
    • Report a side effect of a medicine
    • Report an issue with packaging or storage of a medicine
  • Accessing unapproved products
    Information about medicines and medical devices, including safety and general information...
    • Special access scheme
    • Authorised prescribers
    • Clinical trials
    • Personal import scheme
    • Accessing medicines during a medicine shortage
  • Health professional information & education
    Information for health professionals about therapeutic goods, including safety and general information...
    • Safety information for health professionals
    • Health professional educational materials
    • Access to medicinal cannabis products
    • Medicines
    • Medical devices
    • Other web resources for health professionals
    • Medicine Shortages Information Initiative

Industry

Do you supply and/or manufacture therapeutic goods or want to?

This section includes information about the regulation of therapeutic goods in Australia, including standards and guidelines for different product types.

• Industry
  • SME Assist
    Information to help small & medium enterprises (including R&D groups developing new products) better understand Australian therapeutic goods regulation...
    • Basics of therapeutic goods regulation
    • Overview of applying for market authorisation
    • Medical devices regulation: an introduction
    • When to engage with the TGA
    • Useful resources for business
    • Is my product a therapeutic good?
    • What classification is my medical device
    • Training sessions
  • Regulation basics
    Basics of therapeutic goods regulation & information relevant to all products...
    • How therapeutic goods are regulated in Australia
    • Australian Register of Therapeutic Goods
    • Industry educational materials
    • Legislation & legislative instruments
    • Advertising therapeutic goods
    • Labelling & packaging
    • Import and export
    • Clinical trials
    • Medicinal cannabis products
    • Cosmetics
    • Safety information for industry
  • Prescription medicines
    Regulation of prescription medicines, requirements, standards, guidelines...
    • Prescription medicines regulation basics
    • Standards & guidelines for prescription medicines
    • Forms for prescription medicine sponsors
    • Regulatory decisions and notices (prescription medicines)
  • Over-the-counter medicines
    Regulation of OTC medicines, requirements, standards, guidelines...
    • OTC medicines regulation basics
    • Standards, guidelines & publications (OTC medicines)
    • Forms for OTC medicine sponsors
    • Regulatory decisions & notices (OTC medicines)
  • Complementary medicines
    Regulation of complementary medicines, requirements, standards, guidelines...
    • Complementary medicine regulation basics
    • Standards, guidelines & publications (complementary medicines)
    • Forms for complementary medicine sponsors
    • Complementary medicines reforms
    • Regulatory decisions & notices (complementary medicines)
  • Sunscreens
    Regulation of sunscreens, requirements, standards, guidelines...
    • Sunscreens regulation basics
    • Standards, guidelines & publications (sunscreens)
  • Medical devices & IVDs
    Regulation of medical devices & in vitro diagnostic medical devices, requirements, standards, guidelines...
    • Medical devices regulation basics
    • IVD medical devices regulation basics
    • Standards, guidelines & publications (medical devices & IVDs)
    • Forms for medical device & IVD sponsors
    • Medical devices reforms
    • Regulatory decisions & notices (medical devices & IVDs)
  • Biologicals
    Regulation of biologicals, requirements, standards, guidelines...
    • Regulatory framework for biologicals
    • Standards, guidelines & publications (biologicals)
    • Forms for the biologicals industry
  • Blood and blood components
    Regulation of blood & tissues, requirements, standards, guidelines...
    • Regulation of blood
    • Autologous human platelet-rich plasma and conditioned serum
    • Forms for the blood and blood components industry
  • Other therapeutic goods
    Regulation of other therapeutic goods, requirements, standards, guidelines...
    • Disinfectants & sterilants
    • Tampons & menstrual cups
  • Manufacturing therapeutic goods
    Regulation of manufacturers, requirements, standards, guidelines...
    • Manufacturing basics
    • Manufacturing medicines
    • Manufacturing medical devices & IVDs
    • Manufacturing biologicals
    • Manufacturing blood and blood components
    • Manufacturing inspections
    • Forms for manufacturers
    • Notices for manufacturers
    • Notices about GMP clearance
  • Scheduling of medicines & poisons
    What is scheduling, the Poisons Standard, requirements & guidelines...
    • Scheduling basics
    • Scheduling committees meeting dates and decisions timeframes
    • The Poisons Standard (the SUSMP)
    • Public notices about scheduling
    • State/Territory scheduling information

About the TGA

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. We carry 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.

• About the TGA
  • TGA basics
    Who we are, what we do, corporate information...
    • Who we are & what we do
    • What the TGA doesn't do
    • Structure
    • TGA plans & reports
    • TGA reforms
    • Publications
    • Forms
    • Freedom of information
    • Acronyms & glossary
    • TGA Internet site
    • TGA on social media
  • Contact the TGA
    How you can contact us, email, phone, post, fax...
    • How can we help?
    • TGA customer service standards
    • Report a perceived breach or questionable practices
    • Website feedback or error reporting
    • Translate this website
  • Educational materials
    TGA educational materials and learning modules...
    • For consumers
    • For health professionals
    • For industry
    • For university students
  • Compliance actions
    Decisions in relation to individual sponsors, manufacturers and advertisers...
    • Regulatory compliance framework
    • Compliance undertaking
    • Court action
    • Cancellations
    • Suspensions
    • Complaints about advertisements
  • Regulatory decisions & notices
    Decisions and notices...
    • Consent to import, supply or export goods that do not comply with standards
    • Cancellation requested by the sponsor - regulatory actions
    • Failure to pay annual charges - regulatory actions
    • TGA laboratory testing results
    • Decisions to withdraw medicines advertising approval
  • Committees
    Statutory committees, other committees...
    • TGA statutory advisory committees
    • Other committees
  • Employment & job vacancies
    Working for the TGA, what jobs are available...
    • Job vacancies
    • Working for the TGA
    • Recruitment information
    • Living in Canberra
    • Graduate recruitment
  • Fees & payments
    Fees, payments, policies, notices for sponsors about fees...
    • Schedule of fees and charges
    • Payment options
    • Information & notices about TGA fees & payments
    • Cost recovery implementation statements
    • Forms (fees & payments)
    • Annual Charge Exemption (ACE) scheme
  • TGA Business Services
    The TGA's web-based application portal...
    • TGA business services website
    • TGA Business services: getting started with the TGA
    • TGA Business services - how to use the site
    • TGA Business Services forms
  • International
    Information about our international activities, agreements & links to overseas organisations...
    • International activities
    • International cooperation
    • Use of international assessments
    • TGA international engagement strategy
    • Links to international agencies & organisations
  • TGA Internet site archive
    Archived content from tga.gov.au...
    • Archived committee information
    • Archived consultations & reviews
    • Archived media releases
    • Archived presentations
    • Archived regulatory decisions & notices
    • Archived TGA publications & articles

News room

This section includes links to news and updates about the regulation of therapeutic goods in Australia, as well as activities undertaken by the TGA.

• News room
  • News & public notices
    News, what's changed, subscribe to receive updates, gazette notices, tenders...
    • Latest news & updates
    • Media releases & statements
    • Behind the news
    • Newsletters & articles
    • Subscribe to updates
    • TGA tenders
  • Consultations & reviews
    Current & closed consultations & reviews...
    • Open consultations & reviews
    • Closed consultations & reviews
    • About consultations
    • Medicines and medical devices regulation review
    • Consultation forecast
  • Events, training & presentations
    Events & training coming up, copies of presentations by TGA staff...
    • Events & training
    • Presentations