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THERAPEUTIC GOODS ACT 1989 - SECT 32JH

Secretary may require information etc. about biologicals exempt where substitutes are unavailable etc.

  (1)   The Secretary may give to a person who is granted an approval under subsection   32CO(1), (1A) or (2) in relation to a biological a written notice requiring the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:

  (a)   the supply of the biological;

  (b)   the handling of the biological;

  (c)   the monitoring of the supply of the biological;

  (d)   the results of the supply of the biological;

  (e)   any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Compliance

  (2)   A person given a notice under subsection   (1) must give the information, or produce the documents, to the Secretary:

  (a)   within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

  (b)   in the form specified in the notice.

Note:   Section   32JI contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section   32JJ contains a civil penalty for giving false or misleading information or documents.

  (3)   The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements:

  (a)   on a specified kind of data processing device; or

  (b)   by way of a specified kind of electronic transmission.


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