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Manufacturing therapeutic goods
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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.
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
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| Phone |
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
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| 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 136 Narrabundah Lane Symonston ACT 2609 Australia |