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Therapeutic Goods Regulations 1990
Sch 4Therapeutic goods required to be included in the part of the Register for listed goods
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Schedule 4—Therapeutic goods required to be included in the part of the Register for listed goods
(regulation 10)
| Item No. | Therapeutic goods |
|---|---|
| 1 | therapeutic goods manufactured in Australia for export only other than goods exempt under regulation 12 |
| 3 | medicines where:(a) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(b) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; and(c) the ingredients in the medicine are not of a kind required to be sterile; and(ca) the medicine does not contain a substance included in a Schedule to the Poisons Standard; and(d) the medicine only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act; and(e) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened |
| 4A | homoeopathic preparations where:(a) the preparation consists of, or contains a dilution of, mother tincture that is a 1,000 fold dilution, or a lesser dilution, of that mother tincture; and(b) the preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(c) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the preparation—none of the requirements have been contravened; and(d) the preparation is not required to be sterile; and(e) the preparation does not contain a substance (other than one that is more than a 1,000‑fold dilution of mother tincture) included in a Schedule to the Poisons Standard; and(f) the preparation only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act; and(g) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened |
| 5 | homoeopathic preparations where:(a) each dilution is more dilute than a 1,000 fold dilution of mother tincture; and(b) the preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(c) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the preparation—none of the requirements have been contravened; and(d) the preparation is not required to be sterile; and(e) the preparation only has indications that are covered by a determination under paragraph 26BF(1)((a) of the Act; and(f) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened |