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Therapeutic Goods Regulations 1990
Sch 5Therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act
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Schedule 5—Therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act
(subregulation 12(1))
| Column 1Item No. | Column 2Therapeutic goods |
|---|---|
| 1 | therapeutic goods that are imported for use in the treatment of the importer or the importer’s immediate family where:(a) the goods do not contain a substance the importation of which is prohibited under the Customs Act 1901; and(b) the goods are not any of the following:(i) disposable therapeutic vapes;(ii) therapeutic vaping substances;(iii) therapeutic vaping substance accessories;(iv) a therapeutic vaping kit;(v) goods in a therapeutic vaping pack; and(ba) for a biological—the biological is the subject of an approval under section 32CK of the Act; and(c) in the case of other medicines:(i) the quantity imported in one importation is not more than 3 months’ supply at the maximum dose recommended by the manufacturer; and(ii) the total quantity of the medicine imported for use in the treatment of the importer or the importer’s immediate family in the period of 12 months ending on the day on which the latest importation occurs does not exceed 15 months’ supply of the medicine at the maximum dose recommended by the manufacturer;or the medicines have been approved, or are included in a class of medicines that has been approved, under regulation 5 of the Customs (Prohibited Imports) Regulations 1956 for importation into Australia; and(d) if the goods are subject to Schedule 4 or Schedule 8 to the Poisons Standard—the goods are the subject of a written authority issued by a medical practitioner, except where the goods are carried by the importer as a passenger on a ship or aeroplane |
| 1A | therapeutic goods that are disposable therapeutic vapes, therapeutic vaping substances or therapeutic vaping substance accessories, imported into Australia by a person (the first person) on board a ship or aircraft, if:(a) the therapeutic goods are for use in the treatment of the first person or one or more other persons on board the ship or aircraft under the care of the first person; and(b) the importation of the therapeutic goods meets the requirements of paragraph 5(2)(b) or subregulation 5A(2) of the Customs (Prohibited Imports) Regulations 1956 |
| 2 | therapeutic goods that are exported and that:(a) are not for commercial supply; and(b) do not contain a substance the exportation of which is prohibited under the Customs Act 1901; and(c) are not intended for use in clinical trials on humans |
| 3 | samples of therapeutic goods imported, exported, manufactured, or supplied for:(a) submission to a regulatory authority; or(b) subjection to developmental or quality control procedures; or(c) examination, demonstration or display; or(d) subjection to laboratory testing procedures;but not for supply for therapeutic use in humans |