Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 25

Appointment of analysts and official analysts and powers of official analysts

  (1)   The Secretary may, in writing, appoint a person who has appropriate qualifications and experience to be an analyst or an official analyst for the purposes of these Regulations.

  (3)   In addition to the other powers and functions of an official analyst, an official analyst may:

  (a)   ask an authorised officer to take samples of therapeutic goods; and

  (b)   determine the tests that are to be performed on a sample taken under paragraph   (a) or delivered under paragraph   28(5)(h) or subsection   41FN(2) of the Act; and

  (c)   nominate an analyst or official analyst to be the responsible analyst for a sample taken under paragraph   (a) or delivered under paragraph   28(5)(h) or subsection   41FN(2) of the Act.

  (4)   The tests determined under paragraph   (3)(b), by an official analyst, for the following matters must be tests covered by regulation   28:

  (a)   determining whether particular therapeutic goods (other than medical devices) are goods that conform with a standard applicable to the goods;

  (b)   determining whether a particular kind of medical device complies with the applicable provisions of the essential principles.

  (5)   The tests determined under paragraph   (3)(b), by an official analyst, for a matter not covered by subregulation   (4), are the tests that the official analyst considers appropriate.


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