Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 7

Therapeutic goods exempt from the operation of Part 3-3 of the Act unless supplied as pharmaceutical benefits

(regulation   17)

 

 

Column 1
Item No.

Column 2
Therapeutic goods

1

goods prepared for the initial experimental studies in human volunteers

2

ingredients, except water, used in the manufacture of therapeutic goods where the ingredients:

(a) do not have a therapeutic action; or

(b) are herbs, bulk hamamelis water or oils extracted from herbs, the sole therapeutic use of which is as starting materials for use by a licensed manufacturer

6

dentifrices that contain no therapeutically active substance other than not more than 1000 milligrams per kilogram of fluoride

7

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

8

antiperspirant preparations that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only

9

unmedicated anti - acne preparations having only a cleansing action or purpose

10

medicated insect repellents for dermal use, if the medication consists solely of an antiseptic having a secondary role in the formulation

11

lotions, shampoos or hairdressings for the prevention or treatment of dandruff

11A

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)

12

medicated soaps other than liquid medicated soaps

13

disinfectants

15

medicated throat lozenges, where the medication consists only of volatile oils and their constituents either alone or in combination with ascorbic acid or its salts

16

medicated space sprays where the medication consists only of volatile oils and their constituents

17

bulk, liquified medical gases

18

blood and blood components that are:

(a) collected by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, in the course of medical treatment and for the purposes of diagnosis of, and testing for, a medical condition; or

(b) manufactured by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, for therapeutic application to a patient under the practitioner's care; or

(c) manufactured by a blood donation centre for a medical practitioner, registered under a law of a State or Territory, for therapeutic application to a particular patient under the practitioner's care

19

allergens for skin patch testing on unbroken skin

20

Medicinal oxygen cylinders that have been decant filled, transfilled or cascade filled by:

(a) a hospital; or

(b) an ambulance, fire or rescue service

21

Therapeutic goods in relation to which all of the following paragraphs apply:

(a) the goods comprise, contain or are derived from human cells or human tissues collected from a patient who is under the clinical care of a medical or dental practitioner;

(b) the goods are manufactured by, or under the professional supervision of, the practitioner;

(c) the single indication of the goods is homologous use:

(i) on that patient; and

(ii) in a single clinical procedure; and

(iii) by, or under the professional supervision of, that practitioner;

(d) the goods have been subjected to only minimal manipulation;

(e) the practitioner is registered in a State or internal Territory

22

radiopharmaceuticals that are:

(a) manufactured by:

(i) a medical practitioner registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a medical practitioner; or

(ii) a radiochemist when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a radiochemist; or

(iii) a pharmacist registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a pharmacist; and

(b) for supply to another public or private hospital, another public institution or a private institution within Australia for the purposes of:

(i) diagnosing a medical condition in respect of a patient of the hospital or institution; or

(ii) treating a medical condition of a patient of the hospital or institution

23

radiopharmaceutical active ingredients that are:

(a) manufactured by:

(i) a medical practitioner registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a medical practitioner; or

(ii) a radiochemist when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a radiochemist; or

(iii) a pharmacist registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a pharmacist; and

(b) for supply to another public or private hospital, another public institution or a private institution within Australia, which are then used by the hospital or institution to manufacture a radiopharmaceutical for the purposes of:

(i) diagnosing a medical condition in respect of a patient of the hospital or institution; or

(ii) treating a medical condition of a patient of the hospital or institution



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