Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 27

Examination and testing of sample

  (1)   A samples officer must, as soon as practicable after receiving a sample of goods at a laboratory operated by the Department:

  (a)   determine whether the sample is appropriately fastened and sealed; and

  (b)   if the sample is appropriately fastened and sealed--store the sample under the officer's control and under secure conditions that are appropriate to the kind of goods.

  (2)   The responsible analyst must, as soon as practicable, collect the sample from the samples officer and arrange for:

  (a)   an analysis of the sample by performing the tests determined under paragraph   25(3)(b) in relation to the sample to establish:

  (i)   the quantity and quality of the goods comprising the sample; and

  (ii)   any other matter relevant to determining whether:

  (A)   for goods other than medical devices--the goods from which the sample was taken conform with any standard applicable to the goods and any conditions relating to matters mentioned in paragraph   28(2)(d) of the Act; and

  (B)   for medical devices--the goods from which the sample was taken comply with the applicable provisions of the essential principles and any conditions relating to matters mentioned in paragraph   41FO(2)(d) of the Act; and

  (iii)   for a sample of medicine listed under section   26A or 26AE of the Act--whether the medicine contains an ingredient that is not specified in a determination under paragraph   26BB(1)(a) of the Act or whether any of the requirements determined under paragraph   26BB(1)(b) of the Act have been contravened; and

  (b)   an examination of the goods, the label (if any) relating to the goods and the packaging of the goods, to determine whether the goods comply with the labelling, packaging and other requirements (including requirements relating to advertising) applicable to the goods.


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