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THERAPEUTIC GOODS ACT 1989 - SECT 32DN

Transitional provisions for existing biologicals

Biologicals currently included in the Register

             (1)  If, immediately before the commencement of this section, therapeutic goods that are a biological were included in relation to a person:

                     (a)  in the part of the Register for goods known as registered goods; or

                     (b)  in the part of the Register for goods known as listed goods; or

                     (c)  in the part of the Register for medical devices included in the Register under Chapter 4;

then, as soon as practicable after the commencement of this section, the Secretary must:

                     (d)  by writing, cancel the inclusion of the goods in that part; and

                     (e)  include the biological in the Register under this Part in relation to the person; and

                      (f)  vary the Register as a result of that cancellation and inclusion.

Pending applications

             (2)  If:

                     (a)  before the commencement of this section, an application was made for the registration or listing of therapeutic goods that are a biological or for the inclusion of such goods in the Register under Chapter 4; and

                     (b)  immediately before that commencement, the application was not finally determined; and

                     (c)  the application has not been, and is not, withdrawn either before or after that commencement; and

                     (d)  the application is successful when it is finally determined; and

                     (e)  the goods are included:

                              (i)  in the part of the Register for goods known as registered goods; or

                             (ii)  in the part of the Register for goods known as listed goods; or

                            (iii)  in the part of the Register for medical devices included in the Register under Chapter 4;

then, as soon as practicable after that inclusion, the Secretary must:

                      (f)  by writing, cancel the inclusion of the goods in that part; and

                     (g)  include the biological in the Register under this Part in relation to the person; and

                     (h)  vary the Register as a result of that cancellation and inclusion.

             (3)  For the purposes of this section, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.

Notice of decisions

             (4)  The Secretary must give the person written notice of the cancellation and inclusion under subsection (1) or (2).

Biological number

             (5)  If the Secretary includes the biological in the Register under subsection (1) or (2), 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

             (6)  As soon as practicable after the biological has been included in the Register under this Part, the Secretary must give to the person a certificate of the inclusion of the biological in the Register.

             (7)  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 under this Part commences.

Duration of inclusion in the Register

             (8)  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.

Annual charge

             (9)  If, during a financial year, the Secretary includes a biological in the Register under subsection (1) or (2), subsection 4(1AA) of the Therapeutic Goods (Charges) Act 1989 does not apply in relation to the biological for that financial year.

No review of decisions

           (10)  A decision under this section is taken not to be an initial decision for the purposes of section 60.



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