16Therapeutic goods and gazetted groups

#### 16 Therapeutic goods and gazetted groups (1) For the purposes of this Part, therapeutic goods (other than medicine of the kind to which subsection (1A) applies) are to be taken to be separate and distinct from other therapeutic goods if they have: (a) a different formulation, composition or design specification; or (b) a different strength or size (disregarding pack size); or (c) a different dosage form or model; or (d) a different name; or (e) different indications; or (f) different directions for use; or (g) a different type of container (disregarding container size). (1A) Medicines that are listable goods (other than export only medicines) are taken to be separate and distinct from other therapeutic goods if the medicines have: (a) different active ingredients; or (b) different quantities of active ingredients; or (c) a different dosage form; or (d) such other different characteristics as the regulations prescribe; from the therapeutic goods. (2) The Secretary may, by order published in the Gazette, determine that a group of therapeutic goods (not being medical devices) identified in the order is a gazetted therapeutic goods group because the goods within the group have common characteristics. (3A) The Secretary may, by order published in the Gazette, determine that a group of kits identified in the order is a gazetted kits group. (4) An order under subsection (2) or (3A) may make provision for or in relation to a matter by applying, adopting or incorporating, with or without modification, a document as in force from time to time, if the document is: (a) published by the Department (whether in electronic form or otherwise); and (b) available for sale to the public; and (c) available for inspection (whether by using a visual display unit or otherwise) by the public at offices of the Department specified by the Secretary.