Reporting problems

safetyIf you are experiencing an adverse event or think you may be experiencing one, please seek advice from a health professional as soon as possible. The adverse event should then be reported to the TGA.

Please do not call the TGA in an emergency. If you need urgent medical help call 000. If you have experienced an overdose or suspected poisoning, call the Poisons Information Centre, 24 hours a day on 13 11 26.

About reporting

The TGA relies on the public, health professionals and industry to report problems with medicines or medical devices - this allows us to identify and respond to safety matters.

If you are telephoning us to report a problem, please call between 9am to 5pm, Monday to Friday, Australian Eastern Standard Time.

What do you want to do?

Report an adverse event to a medicine

consumer iconSometimes medicines have unexpected and undesirable effects. Please report these problems so we can monitor the safety of medicines in Australia. For general privacy information, visit the Privacy page.

For prescription, over-the-counter and complementary medicines, reports can be made by:

Phone: Consumers/Patients call 1300 134 237 to speak to a pharmacist from the NPS Medicinewise.
Health professionals, manufacturers and sponsors call the TGA on 1800 044 114
Online: Consumers: Report an adverse event using the Report a side effect of a medicine form
Health professionals: You can submit a report to the TGA's Australian Adverse Drug Reaction Reporting System. You can also submit a report directly from MIMS Online
Blue card: A completed 'Blue card' can be submitted to the TGA via email, fax or mail
Email: adr.reports@tga.gov.au
Sponsors and manufacturers can also email reports to e2b.reports@tga.gov.au (ICH E2B formatted reports only)
Fax: +61 2 6232 8392
More information:

Report an adverse event to a vaccine

vaccine iconSometimes vaccines have unexpected and undesirable effects. Please report these problems so we can monitor the safety of vaccines in Australia. For general privacy information, visit the Privacy page.

Immunisation providers should report adverse events following immunisation to their relevant state/territory health authority. Contact details for state/territory health authorities can be found in the Australian Immunisation Handbook.

For vaccines, reports can be made by:

AEFI form: A completed National Adverse Events Following Immunisation (AEFI) reporting form can be submitted to the TGA via email, fax or mail.
Phone: Consumers/Patients call 1300 134 237 to speak to a pharmacist from the NPS Medicinewise.
Manufacturers and sponsors call the TGA on 1800 044 114
Online: Consumers: Report an adverse event using the Report a side effect of a medicine form
Health professionals: You can submit a report to the TGA's Australian Adverse Drug Reaction Reporting System. You can also submit a report directly from MIMS Online
Email: adr.reports@tga.gov.au
Sponsors and manufacturers can also email reports to e2b.reports@tga.gov.au (ICH E2B formatted reports only)
Fax: +61 2 6232 8392
More information:

Report a problem with a medical device

medical devicesTypical problems with medical devices include deficiencies in labelling, instructions or packaging, defective components, performance failures and/or poor construction or design. For general privacy information, visit the Privacy page.

Phone: 1800 809 361
Online: Users Medical Device Incident Report
Sponsors/Manufacturers Medical Device Incident Report
Email: iris@tga.gov.au
Fax: +61 2 6203 1713

Report a medicine or vaccine deficiency or defect

consumer iconPlease report problems that may have arisen during manufacture, storage or handling. For general privacy information, visit the Privacy page.

Phone: 1800 044 114
Form: Medicine or vaccine defect report form

Report counterfeit medicines or medical devices

consumer iconIf you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Phone: 1800 020 653
Online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email: info@tga.gov.au

More

National Relay Service

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 044 114
  • Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 044 114
Mail

Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia

(Please include the type of report in the address block)