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.
