Click on the plus or minus icon next to the question to toggle the answer on or off or [Open all | Close all].
If you want to print all questions & answers, you need to Open all before you print.
What is a generic medicine?
A generic medicine is an additional brand of an existing medicine. It contains the same active ingredient (the chemical that makes the medicine work) as the existing medicine.
Apart from containing the same active ingredient, generic brands also have to be 'bioequivalent'. That is, if you take the same dose of a generic medicine as an existing medicine, the same amount of active ingredient is absorbed by your body over the same period of time.
Bioequivalence is demonstrated by conducting a 'bioavailability' study in which volunteers (usually healthy) are given the original medicine and, on a separate day, the generic medicine. Blood samples are taken at different times, and the rate and extent of absorption of the active ingredient into the blood is compared between the generic and existing medicines.
Generic medicine containing the same active ingredient can be manufactured and sold by other companies once the patent for the existing brand has expired.
What we do when we authorise a generic prescription medicine for supply?
A generic prescription medicine is only allowed to be supplied in Australia if we consider that the evidence shows that the generic medicine is bioequivalent to the original medicine.
We look at the:
consistency and quality of the manufacturing process for the medicine
the quality of the ingredients and the final product
the combination of ingredients used to make the final medicine product
the safety information obtained from laboratory studies and clinical trials on the original medicine.
We also look at how long the active ingredient remains stable at particular temperatures - this is used to determine shelf life and recommended storage conditions for the medicine.
If necessary, we also make available information on the use of the generic prescription medicine, for example, warnings about using the product and drinking alcohol. These can be found in the Product Information and the Consumer Medicines Information, available from pharmacists and the TGA website.
Are generic prescription medicines effective?
A generic prescription medicine works in the same way as the existing medicine. What matters is the active ingredient, which is the same in the generic brands and the existing brand.
All medicines will have the same potential health benefits, and the same potential side effects. Some active ingredients are only effective for some patients and this will be the case whether you use the original or a generic medicine.
How do I know that generic prescription medicines are as safe as possible?
Generic prescription medicines meet the same standards of quality, safety and effectiveness as the original brand.
As with all medicines and medical devices the TGA continually monitors safety once they are on the market.
If you suspect you have experienced a problem with any medicine, including a generic medicine, please report it to the TGA.
What about the difference in cost between generic prescription medicines and the original version?
The cost of a medicine is not considered by the TGA when deciding whether the medicine can be supplied in Australia. Our role is to ensure that generic prescription medicines are made to the same standard as original medicines.
All brands of the same medicine, regardless of price, have the same active ingredient and have been authorised for supply in Australia.
However, generic prescription medicines may be more affordable for consumers. You can ask your doctor to prescribe a generic medicine, or ask your pharmacist if they are able to supply you with a more affordable brand of the same medicine.
If they are the same, why do they sometimes look or taste different?
Heading overseas? Read our tips for travelling with medicines before you go
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.