1

therapeutic goods manufactured in Australia for export only other than goods exempt under regulation   12

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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

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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

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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

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

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