Therapeutic goods
There are safety standards placed on the sale of therapeutic goods so that consumers can be confident they are safe to use.
Find out how the Therapeutic Goods Administration (TGA) regulates the manufacturing, advertising and safety of medicines and medical products.
Therapeutic goods can include vitamins and sunscreen, and goods used to treat serious conditions, including:
- prescription medicines
- vaccines
- blood products
- surgical implants.
Regulating therapeutic goods
The Therapeutic Goods Administration (TGA) is responsible for the regulation of:
- medicines
- complementary medicines
- medical devices
- products to test for various diseases or conditions
- vaccines and blood products.
The TGA also regulates the manufacturing and advertising of these products.
If a therapeutic product is found to be defective or harmful, the TGA will issue a recall action to protect you.
If you need to report a side effect to medicine or problems with a medical device
You can contact the TGA to report:
- side effects to medicine
- problems and adverse events with medical devices.
You should also contact the TGA to report:
- counterfeit medicines and medical devices
- issues with the packaging or storage of medicines.
Your consumer rights
As a consumer, you have the right to expect that the goods you buy are safe.
Australian Consumer Law requires safety standards to be met before certain goods are sold. These standards include:
- the way the good is made
- what it contains
- how it works
- the tests it needs to pass
- whether any warnings or instructions need to accompany it.
Penalties
The penalty for individuals is $2.5 million.
The penalty for a body corporate is the greater of:
- $50 million
- if the Court can determine the value of the 'reasonably attributable' benefit obtained, 3 times that value, or
- if the Court cannot determine the value of the 'reasonably attributable' benefit, 30% of the corporation's adjusted turnover during the breach turnover period for the contravention.
Making a complaint
If you have a complaint about therapeutic goods, you can contact the TGA.
When making a complaint, you should include:
- details of the issues you are experiencing
- copies of any correspondence that shows how you have tried to resolve the matter.
How Fair Trading will handle your complaint
Your complaint will be reviewed to determine the most appropriate resolution. This may include:
- providing you with information to help resolve your complaint
- recording the complaint issues to assist in future compliance programs, or
- contacting the other party to try and resolve the dispute.
You can lodge a complaint:
Online
If you cannot resolve your matter, submit your complaint by using our form.
By mail
Post your complaint form and documentation to:
NSW Fair Trading
PO Box 972
Parramatta NSW 2124
Ask a question
If you are unable to find the information you need, you can call us between 8:30am to 5pm on Monday to Friday. You can also use our form to make an enquiry.