Licence to Manufacture Therapeutic Goods - Australian Government


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.

Service type


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.

Ongoing eligibility requirements

You must not fail to comply with any conditions of the licence.


Ongoing unless cancelled or suspended


Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Fees are listed on the attached document.


Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Transfer process


Please consult the Contact Officer for more information regarding transfers.

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

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