Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 8

Persons exempt from the operation of Part 3-3 of the Act

(regulation   18)

 

 

Column 1
Item

Column 2
Persons

Column 3
Matter in relation to which person exempted

1

medical practitioners, dentists and other health care workers registered under a law of a State or Territory

the manufacture of a medicine by a medical practitioner or a dentist specifically for a patient under the medical practitioner's or dentist's care

2

pharmacists

the manufacture of therapeutic goods, if:

(a) the goods are not biologicals; and

(b) the goods are produced by the pharmacist:

(i) in a pharmacy where the pharmacist practices and the pharmacy is open to the public; or

(ii) on the premises of a dispensary conducted by a Friendly Society; or

(iii) on the premises of a private hospital; and

(c) the goods are for supply (other than by wholesale) on or from those premises

3

biomedical engineers, radiochemists and pharmacists in public hospitals

the manufacture of therapeutic goods, other than biologicals, by the person when employed by a public hospital or a public institution and produced by that person for supply in hospitals or public institutions in the same State or Territory

4

herbalists, nutritionists, naturopaths, practitioners of traditional Chinese medicine or homoeopathic practitioners engaged in the manufacture of any herbal, homoeopathic or nutritional supplement preparation

where the preparation is for use in the course of his or her business and:

(a) the preparations are manufactured on premises that the person carrying on the business occupies and that he or she is able to close so as to exclude the public; and

(b) the person carrying on the business:

(i) supplies the preparation for administration to a particular person after consulting with that person; and

(ii) uses his or her own judgment as to the treatment required

5

a person who applies supplementary labelling to a manufactured product

the application of supplementary labelling, where the supplementary label contains only a name and address, the registration or listing number of goods, or the biological number of a biological

6

a person who re - labels a product to comply with the labelling requirements of the Standard for the Uniform Scheduling of Drugs and Poisons (commonly known as "the Poisons Standard")

the application of the new label

7

charities

the manufacture of packs mentioned in item   14 of Schedule   5A



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