In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence or a conformity assessment certificate. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence or a conformity assessment certificate unless the manufacturer or goods are exempt from this requirement.
- Manufacturing basics
General information about how manufacturing of therapeutic goods is regulated in Australia - Manufacturing medicines
Information for manufacturers of medicines - Manufacturing medical devices & IVDs
Information for medical device and in vitro diagnostic medical devices manufacturers - Manufacturing biologicals
Information for manufacturers of biologicals - Manufacturing blood & blood components
Information for manufacturers of blood and blood components - Manufacturing inspections
TGA inspectors inspect Australian and overseas manufacturers of therapeutic goods - Forms for manufacturers
Forms for manufacturers of therapeutic goods - Notices for manufacturers
Notices and advice for manufacturers of therapeutic goods - Notices about GMP clearance
Notices for sponsors about the processing of GMP clearance applications
Contact details for enquiries about manufacturing therapeutic goods
If your enquiry is not about manufacturing, see: Contact the TGA
If your enquiry is about manufacturing medical devices: Contact the Medical Devices Branch
|
|
| Phone |
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
|
| Fax | +61 2 6232 8426 |
| Postal address | Manufacturing Quality Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia |
| Street address (for deliveries) |
Therapeutic Goods Administration 27 Scherger Drive Fairbairn ACT 2609 Australia |
Topics