Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 32DCB

Inclusion of export only biological in the Register

Secretary must include biological in Register

  (1)   The Secretary must include an export only biological in the Register in relation to a person if:

  (a)   an application is made under subsection   32DCA(1) for the biological to be included in the Register in relation to the person; and

  (b)   the application complies with subsection   32DCA(2); and

  (c)   if one or more steps in the manufacture of the biological have been carried out outside Australia and the Secretary is required to make a decision under subsection   32DCA(5)--the Secretary has certified, under that subsection, that the manufacturing and quality control procedures used in each such step are acceptable.

Biological number

  (2)   If the Secretary includes the biological in the Register, the Secretary must assign a unique number to the biological. The number assigned may be any combination of numbers and either or both of letters and symbols.

Note:   The number assigned is the biological number of the biological.

Certificate

  (3)   As soon as practicable after the biological has been included in the Register, the Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.

  (4)   The certificate must:

  (a)   specify the biological number of the biological; and

  (b)   specify the day on which the inclusion of the biological in the Register commences.

Duration of inclusion in the Register

  (5)   The biological remains included in the Register in relation to the person until the Secretary cancels the entry of the biological from the Register under this Part.

Note:   The biological is taken not to be included in the Register while it is suspended: see section   32FD.


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