Definition: In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt from this requirement. To obtain a licence to manufacture therapeutic goods, a manufacturer must demonstrate, during a factory audit, compliance with manufacturing principles which includes relevant Codes of GMP and Quality Systems. As per: TGA

Definition: Therapeutic goods that are required by the Act to be included in that part of the ARTG relating to Listed goods. As per: TGA

Definition: Therapeutic goods that are included in the part of the ARTG for goods known as Listed goods. As per: TGA

Definition: See AUST L number. As per: TGA