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.
A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.
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.
Ongoing unless cancelled or suspended.
Licence application fee (excluding biologicals) $1025. Inspection fees may apply. Please consult the Contact Officer for more information.
Application for a Licence to Manufacture Therapeutic Goods - Please consult the Contact Officer for more information.
Department of Health
Therapeutic Goods Administration
Therapeutic Goods Act 1989 (Australian Government)
Therapeutic Goods Regulations 1990 (Australian Government)
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