Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32ea:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32EA (pt 2/3)
Character Range: 505375–507929

of samples of the biological if the Secretary so requests:
 (a) within the period, of not less than 14 days after the day the request is made, specified in the request; and
 (b) in accordance with any other requirements specified in the request.

Manufacturing
 (4) The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will:
 (a) if a manufacturer who was not nominated as a manufacturer of the biological in the application for inclusion of the biological in the Register is to become a manufacturer of a step in the manufacture of the biological—inform the Secretary in writing of that fact and of the name and address of that manufacturer before that manufacturer begins to carry out that step; and
 (b) if premises that were not nominated in the application as premises to be used in the manufacture of the biological are to become premises used in a step in the manufacture of the biological—inform the Secretary in writing of that fact and of the name and address of the new premises before the premises are first so used.
 (5) The inclusion of a biological, other than a Class 1 biological, in the Register is subject to a condition that:
 (a) each step in the manufacture of the biological that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3‑3 in relation to that step; and
 (b) each step in the manufacture of the biological that is carried out outside Australia is the subject of a certification in force under subsection 32EB(2).
 (6) Subsection (5) does not apply if the biological is exempt from the operation of Part 3‑3.
 (7) Paragraph (5)(b) does not apply in relation to a step that was the subject of any evaluation under section 32DE. This subsection ceases to apply in relation to that step if either or both of the following occur:
 (a) that step begins to be carried out at premises that are different from the premises in respect of which that evaluation was conducted;
 (b) that step begins to be carried out by a manufacturer that is different from the manufacturer in respect of which that evaluation was conducted.
 (7A) Paragraph (5)(b) does not apply in relation to a step that:
 (a) is the subject of a certification in force under subsection 32DCA(5); or
 (b) was not required to be the subject of a decision under that subsection because of subsection 32DCA(7).
 (7B) Paragraph (7A)(a) ceases to apply in relation to