Document ID: chunk:federal_register_of_legislation:C2010A00054:clause:1_32ea:p2
Version: federal_register_of_legislation:C2010A00054
Segment Type: clause
Provision Reference: sch 1 cl 32EA (pt 2/2)
Character Range: 104061–106132

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 the 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.

Expiry date
 (8) 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 not supply a batch of the biological in Australia, or export a batch of the biological from Australia, after the expiry date for the biological.

Advertising
 (9) 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 not, by any means, advertise the biological for an indication other than an indication accepted in relation to that inclusion.