Medicines & medical devices
The information in this section is about medicines and medical devices and has been written for consumers, patients and carers.
- Consumer guide to commonly noted advertising breaches
Summary of commonly recorded breaches of the therapeutic goods advertising requirements
- Counterfeit medicines and devices
Products are considered counterfeit if the labeling, presentation, advertising, formulation or source of the goods is false
- What are 'therapeutic goods'?
Many of us use medicines or medical devices in our daily lives
- Biosimilar medicines - information for consumers
Biological medicines are medical products extracted or genetically engineered from living organisms
- OTC medicines: guidelines and processes update 2013: Information for consumers
On 15 April 2013, the TGA and Medsafe will commence the introduction of new administrative procedures for the processing of new and changed over the counter (OTC) medicine applications
- Availability of morphine sulfate injection products: Information for consumers
The TGA has been notified by the pharmaceutical company, Hospira that it has issues with their supply of morphine 10mg/1mL injections due to a recent upgrade problem at their European manufacturing plant for their product.
- Cough and cold medicines for children - changes
Advice to consumers and health professionals on cough and cold medicines for children
- What's on a medicine label?
A medicine label tells you what you are buying, what it can do for you and how to use it to get the best results. It provides important information about storage conditions and the expiry date.
- Consumer Medicines Information (CMI)
The Consumer Medicines Information (CMI) is a leaflet that contains information on the safe and effective use of a prescription or pharmacist-only medicine
- Medicines and TGA classifications
Australia has a two-tiered system for the regulation of medicines, including complementary medicines
- Safe disposal of unwanted medicines
Unwanted medicines can be returned to local pharmacies involved in the Return Unwanted medicines (RUM) Project
- List of evaluated registered complementary medicines
Sponsors seeking registration of new complementary medicines are required to submit to the TGA a detailed dossier of information for evaluation
- Recommended paracetamol doses
The TGA has considered the changes in the USA and the UK and recommends that there should be no change to recommended paracetamol dosing regimens in Australia
- Adverse events: Australian statistics on medicines
The Office of Product Review of the Therapeutic Goods Administration, prepares reports for incorporation into the Department of Health publication Australian Statistics on Medicines
- Australian Public Assessment Reports for prescription medicines (AusPARs)
An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application
- BSE risk associated with the use of materials of bovine origin during the manufacture of vaccines
These questions and answers explain the BSE related issues associated with vaccines registered by the TGA
- Buying medical devices
When buying a medical device it is advisable to only choose a medical device that is recommended by a healthcare professional and has been included on the ARTG
- Metal-on-metal hip implants: Information for patients
Information for patients who have had hip replacement surgery
- Medical devices reforms
The TGA has begun work on a series of reforms to the regulation of medical devices, including the hip, knee and shoulder joint implant reclassification
- The use of point of care tests for HIV in Australia
Background to the status of rapid tests for HIV in Australia
- What is a medical device?
Medical devices are used on humans, have therapeutic benefits, have a physical effect on the body
- How to tell if a medical device is legally supplied for use in Australia
Unless exempt, medical devices must be 'included' onto the ARTG before they may be supplied in or exported from Australia
- Medical devices: providing feedback to the TGA
There are various feedback mechanisms available