Therapeutic Goods Regulations 1990

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therapeutic goods that are imported for therapeutic 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;

(vi) nicotine pouches; 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 therapeutic 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; and

(iii) the medicine is in packaging that enables the medicine to be accurately identified;

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) in the case of goods that are subject to Schedule 4 or Schedule 8 to the current Poisons Standard—the goods are the subject of a written authority issued by the following:

(i) if the goods are carried by the importer as a passenger on a ship or an aeroplane—a medical practitioner, or an overseas medical practitioner treating the importer or the importer’s immediate family;

(ii) otherwise—a medical practitioner

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

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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

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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

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goods imported solely for the purpose of export that remain subject to customs control under the Customs Act 1901 and that are not subject to manufacture in Australia

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medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person, other than the following:

(a) medicines that are used for gene therapy;

(b) medicines that are medicinal cannabis products;

(c) medicines that contain glucagon‑like peptide‑1 (GLP‑1) receptor agonist analogues;

(d) nicotine pouches

6A

medicines (other than medicines that are used for gene therapy or that are medicinal cannabis products) that are:

(a) compounded in a hospital by:

(i) in the case of a private hospital—a hospital pharmacist who is engaged in the manufacture of therapeutic goods (other than biologicals) on the premises of the private hospital; or

(ii) in the case of a public hospital—a pharmacist who is employed by the public hospital and is engaged in the manufacture of therapeutic goods (other than biologicals); and

(b) compounded in anticipation of being needed for therapeutic application to patients of the hospital; and

(c) considered by the hospital’s drug and therapeutic committee (however called) to be appropriate for compounding in anticipation of being needed to treat a patient at the hospital

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manufacturing, laboratory and dispensary equipment used in the preparation of therapeutic goods

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the following goods, unless the goods are for the treatment, cure, prevention, diagnosis or monitoring of, or testing susceptibility of persons to, a disease, condition, ailment or defect:

(a) homoeopathic preparations more dilute than a one thousand fold dilution of a mother tincture and which are not required to be sterile;

and which do not include an ingredient of:

(i) human origin; or

(ii) animal origin, if the ingredient consists of, or is derived from, any of the following parts of cattle, sheep, goats or mule deer:

(A) adrenal;

(B) brain;

(C) cerebrospinal fluid;

(D) dura mater;

(E) eye;

(F) ileum;

(G) lymph nodes;

(H) pineal gland;

(I) pituitary;

(J) placenta;

(K) proximal colon;

(L) spinal cord;

(M) spleen;

(N) tonsil;

(c) unmedicated anti‑acne preparations having only a cleansing action or purpose;

(d) medicated insect repellents for dermal use if the medication consists solely of an antiseptic having a secondary role in the formulation, except those that are included in a Schedule to the Poisons Standard;

(f) disinfectants, except those described in item 16 in Schedule 4

8A

Lotions, shampoos or hairdressings for the prevention or treatment of dandruff, except those that:

(a) are included in a Schedule to the Poisons Standard; or

(b) are also for the treatment, cure, prevention, diagnosis or monitoring of, or testing susceptibility of persons to, another disease, condition, ailment or defect

8B

unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action)

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Starting materials that are ingredients or components for use in the manufacture of therapeutic goods, except when:

(a) prepackaged for supply for other therapeutic purposes; or

(b) formulated as a dosage form; or

(c) the starting materials are nicotine in solution imported for use as an ingredient in a therapeutic good; or

(d) the starting materials are ingredients or components imported for use in the manufacture of:

(i) a therapeutic vaping substance; or

(ii) a therapeutic vaping substance accessory; or

(e) the starting materials are plasma for fractionation to be used in the manufacture of a medicine

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therapeutic goods:

(a) in relation to the importation of which a permission, licence or declaration under regulation 5A, 5B or 5C of the Customs (Prohibited Imports) Regulations 1956 granted or made before the commencement of the Act is in force; and

(b) which are supplied in Australia for use in humans not more than 6 months after the commencement of the Act

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allergens for skin patch testing on unbroken skin, whether or not the allergen is also described in an item in Schedule 3 or 4

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radiopharmaceutical cold kits that are:

(a) containers of sterile reagents to which radioisotope is added immediately before injection into patients; and

(b) manufactured by a radiochemist or a pharmacist in a public or private hospital for subsequent extemporaneous compounding and dispensing for use by, or in connection with:

(i) a patient of that hospital; or

(ii) a patient of another public or private hospital in the same State or Territory

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(a) tampons; and

(b) menstrual cups