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THERAPEUTIC GOODS ACT 1989 - SECT 32DF Inclusion of biological in the Register

THERAPEUTIC GOODS ACT 1989 - SECT 32DF

Inclusion of biological in the Register

  (1)   If:

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

  (aa)   the application has passed preliminary assessment; and

  (b)   the Secretary decides that it is appropriate to include the biological in the Register after an evaluation under section   32DE; and

  (c)   no part of an evaluation fee under section   32DI that is due and payable by the person remains unpaid;

the Secretary must include the biological in the Register in relation to the person.

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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