Licence to Manufacture Therapeutic Goods - Australian Government

Description

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

Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Fees are listed on the attached document.

Forms

Task Business Structure Resources
Apply All Application for a Licence to Manufacture Therapeutic Goods - Please consult the Contact Officer for information on forms to be submitted.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Regulations 1990 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Information Officer, Office of Manufacturing Quality

Therapeutic Goods Administration

Department of Health

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: 02 6221 6881
Phone: 1800 446 443
Fax: 02 6232 8426
Email: gmp@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)