Therapeutic Goods Regulations 1990

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

7

sunscreen preparations for dermal application, if:

(a) the claimed sun protection factor has been established by testing according to the method described in Australian/New Zealand Standard AS/NZS 2604:2021, Sunscreen products ‑ Evaluation and classification, published jointly by, or on behalf of, Standards Australia and Standards New Zealand, as in force from time to time; and

(b) the performance statements and markings on the label comply with that Standard; and

(c) the sunscreen preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and

(d) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the sunscreen preparation—none of the requirements have been contravened; and

(e) the sunscreen 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

8

medicines to be listed under section 26AE of the Act, if:

(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 indications proposed by the sponsor of the medicine are either:

(i) uses of the medicine in preventing, curing or alleviating a disease, ailment, defect or injury in persons, other than a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form; or

(ii) uses of the medicine in connection with alleviating a disease, ailment, defect or injury in persons, being a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form; and

(e) the indications proposed by the sponsor of the medicine do not refer to an indication that is or contains a prohibited representation (within the meaning of Part 5‑1 of the Act

12

kits (to be known as medicine kits) consisting as follows:

(a) solely of medicines—if Part 3‑2 of the Act applies to any of the individual therapeutic goods contained in the kit;

(b) of medicines and biologicals—if:

(i) Part 3‑2 of the Act applies to any of the individual therapeutic goods (other than biologicals) contained in the kit; and

(ii) Part 3‑2A of the Act applies to any of the biologicals contained in the kit

16

hospital grade disinfectants, or household grade disinfectants, that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides

17

a therapeutic vaping kit, if each of the goods in the kit is a registered good