Therapeutic Goods Act 1989

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

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

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

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.

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.

The number assigned is the biological number of the biological.

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.

The certificate must:

specify the biological number of the biological; and

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

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.

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