If 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.
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.
- Make a complaint about advertising
- Report problems with agricultural chemicals or veterinary medicines to the Australian Pesticides & Veterinary Medicines Authority (APVMA)
- Pilot web service for transmission of adverse event reports from medical software to the Therapeutic Goods Administration
What do you want to do?
Report an adverse event to a medicine
Sometimes 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 and vaccines, 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:||You can submit a report to the TGA's Australian Adverse Drug Reaction Reporting System|
|Health professionals 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|
|Vaccines:||National Adverse Events Following Immunisation (AEFI) reporting form|
|Sponsors and manufacturers can also email reports to firstname.lastname@example.org (ICH E2B formatted reports only)|
|Fax:||+61 2 6232 8392|
Report a problem with a medical device
Typical 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|
|Fax:||+61 2 6203 1713|
Report counterfeit medicines or medical devices
If 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|
|National Relay Service||
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
Therapeutic Goods Administration
(Please include the type of report in the address block)