Commonwealth Consolidated Acts

[Index] [Table] [Search] [Search this Act] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

THERAPEUTIC GOODS ACT 1989 - SECT 32JG

Secretary may require information etc. about biologicals exempt for special and experimental uses

Approval under subsection   32CK(1)

  (1)   The Secretary may give to a person who is granted an approval under subsection   32CK(1) 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.

Approval under subsection   32CK(1)--use by another person

  (2)   The Secretary may give to a person (the experimenter ) using a biological that is the subject of an approval:

  (a)   that is held by another person under subsection   32CK(1); and

  (b)   that covers the importation into Australia, or the supply in Australia, of the biological for use solely for experimental purposes in humans;

a written notice requiring the experimenter to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to either or both of the following:

  (c)   the use of the biological;

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

Authority under subsection   32CM(1)

  (3)   The Secretary may give to a person who is granted an authority under subsection   32CM(1) 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.

Authority under subsection   32CM(7A) rules

  (3A)   If a person is authorised, by subsection   32CM(7A) rules, to supply a biological, the Secretary may give the person a written notice requiring the person to give 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

  (4)   A person given a notice under subsection   (1), (2), (3) or (3A) 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.

  (5)   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.


AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback