Report a problem with a therapeutic product
Other problems
- Make a complaint about the advertising of a therapeutic product
<http://www.tga.gov.au/docs/html/advcomplaint.htm> - Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
<http://www.tga.gov.au/problem/breach.htm> - Report a recall of a human blood/tissue product
<http://www.tga.gov.au/docs/html/recallbt.htm>
Report an adverse reaction to a medicine
- Consumer
<http://www.mater.org.au/ame/>
This phone-in service, provided by the Mater Hospital, Brisbane, is available for members of the general public who suspect they have experienced an adverse medicine event. The service forwards reports of suspected adverse reactions to the Adverse Drug Reactions Advisory Committee. - Prepaid reporting form ("blue card")
<http://www.tga.gov.au/adr/bluecard.htm> - Report electronically
<http://www.tgasime.health.gov.au/SIME/ADRS/ADRSRepo.nsf?OpenDatabase> - Reporting problems with unapproved medicines: See Chapter 8, page 214, of Access to unapproved therapeutic goods in Australia <http://www.tga.gov.au/docs/html/unapp.htm> for requirements, criteria and timeframes for reporting adverse events and reactions associated with the use of unapproved medicines in Australia.
Other information about adverse medicine reactions
- Pharmacovigilance for sponsors
<http://www.tga.gov.au/safety/monitoring.htm#medicines> - Adverse drug reactions: frequently asked questions
<http://www.tga.gov.au/adr/adrfaq.htm> - Adverse drug reactions: what to report
<http://www.tga.gov.au/adr/report.htm> - Adverse drug reactions: what information to include in a report
<http://www.tga.gov.au/adr/repinfo.htm> - Adverse drug reactions: what happens to a report
<http://www.tga.gov.au/adr/rephap.htm> - TGA Office of Medicines Safety Monitoring
<http://www.tga.gov.au/adr/index.htm>
Contact details for enquiries about adverse medicine reactions
If your enquiry is not specifically about adverse medicine reactions, see: Contact the TGA
- Email: adrac@tga.gov.au
- Phone:
- 1800 044 114 (freecall within Australia)
- 02 6232 8180
- Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
- TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- Fax: 02 6232 8392
- Post: Office of Medicines Safety Monitoring, TGA, PO Box 100, Woden ACT 2606, Australia
Report a medicine deficiency or defect
- Medicine problem report form
Use this form to report deficiencies or defects of medicines, which are thought to have arisen during manufacture, storage, or handling (not adverse reactions)
Contact details for enquiries about medicine problems (not adverse reactions)
If your enquiry is not specifically about medicine problems, see: Contact the TGA
- Email: info@tga.gov.au
- Phone:
- 02 6232 8637
- 1800 020 653 (freecall within Australia)
- Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
- TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- Fax: 02 6232 8687
- Post: TGA, PO Box 100, Woden ACT 2606, Australia
Report a problem with a medical device
- Reporting form for use by medical device users (eg nurses, doctors, patients)
<http://www.tga.gov.au/docs/html/forms/iris_udir.htm> - Reporting form for use by medical device manufacturers and sponsors
<http://www.tga.gov.au/docs/html/forms/iris_mdir.htm> - Device vigilance for sponsors
<http://www.tga.gov.au/safety/monitoring.htm> - Samples for testing - Protocol for sending medical devices to the TGA for testing
<http://www.tga.gov.au/problem/iris/devices-testing.htm> - Medical device incident reporting and investigation scheme (IRIS) article index
<http://www.tga.gov.au/problem/iris/iris-index.htm> - Medical device incident report statistics
<http://www.tga.gov.au/problem/iris/statistics.htm>
Contact details for enquiries about reporting medical device problems or adverse events
If your enquiry is not specifically about reporting medical device problems or adverse events, see: Contact the TGA
- Email: iris@tga.gov.au
- Phone:
- 02 6232 8713
- 1800 809 361 (freecall within Australia)
- Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
- TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- Fax: 02 6232 8555
- Post: IRIS, TGA, PO Box 100, Woden ACT 2606, Australia
Report a problem with an agricultural chemical or veterinary medicine
This scheme is administered by the Australian Pesticides & Veterinary Medicines Authority (APVMA) <http://www.apvma.gov.au>.