Licence to Manufacture Therapeutic Goods - Australian Government

Service summary

You will require this licence if you intend to manufacture therapeutic goods or biologicals. This covers any drug or device used for the prevention, diagnosis or treatment of disease or other bodily function, or that relate to items on the Poisons Standard (the SUSMP). It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless you or the goods are exempt from this requirement.

Therapeutic goods must comply with various standards and therapeutic goods orders, which determine the consistency of product quality.

Please consult the Contact Officer for more information.

Service type

Licence

A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

Extensive processes are in place to ensure manufacturing organisations comply with high standards and codes of manufacturing practice. A

security assessment of the manufacturing premises will need to be undertaken by an approved security organisation. You may need to hold appropriate licences under State or Territory drugs legislation.

Please consult the Contact Officer for more information on these requirements.

Duration

Ongoing unless cancelled or suspended.

Fees

 TypeAmountDescription
ApplyApplication

Licence application fee (excluding biologicals) $1025. Inspection fees may apply. Please consult the Contact Officer for more information.

VaryVariation$1,025.00

Forms

 Resources
Apply

Application for a Licence to Manufacture Therapeutic Goods - Please consult the Contact Officer for more information.

Other resources

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Regulations 1990 (Australian Government)

Contact details

Information Officer, Office of Manufacturing Quality
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
Office of Manufacturing Quality, TGA, PO Box 100
Woden
Australian Capital Territory 2606

Phone:

1800446443

Phone:

02 62216881

Fax:

02 62328426
gmp@tga.gov.au

Supporting information

Disclaimer

The information contained on the Australian Business Licence and Information Service (ABLIS) web site, or via packages or other sources is intended for general guidance only.

To the full extent permitted by law, the Federal, State, Territory and Local Governments make no representations or warranties (expressed or implied) in relation to the information, including its accuracy, currency or completeness.

The business information provided does not constitute professional or legal advice, nor is the use of any third party resource an endorsement of the information contained, the associated organisation, product or service. It is recommended that you obtain appropriate professional and /or independent legal advice to ensure that the material provided here is relevant to your particular circumstances.

To the full extent permitted by law the Federal, State, Territory and Local Governments, their employees and agents do not accept any liability for any reason, including without limitation, liability in negligence, to any person for the general information which is provided herein, or in respect of anything, including the consequences of anything done, or not done, by any such person in whole or partial reliance upon the information.