Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:61:p2
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 61 (pt 2/3)
Character Range: 150753–153516

paragraph 59A(a) in the manufacture of a chemical product, the licence holder:
 (a) must supervise the performance of that step; and
 (b) must ensure that the respective responsibilities of the contractor and the licence holder in relation to the step are recorded in writing; and
 (c) must ensure that the contractor maintains any records that, under the licence condition imposed by subregulation (3), the licence holder would be required to maintain if the licence holder performed the step; and
 (d) must ensure that:
 (i) the premises at which the contractor performs the step; and
 (ii) the records referred to in paragraphs (b) and (c);
  are made accessible to a person appointed by the APVMA to inspect the operations of the licence holder.
 (7A) The holder of a licence may sub‑contract the manufacture of the chemical products only to:
 (a) a manufacturer, or laboratory, licensed by the APVMA to perform a step in the manufacture of the chemical products; or
 (b) a manufacturer or laboratory located outside Australia that the APVMA has determined complies with a standard of manufacture comparable to the manufacturing principles and the Australian GMP Code.
 (8) If directed by the APVMA CEO, the holder of a licence must:
 (a) undergo an audit by an APVMA inspector, or another person authorised in writing by the APVMA (an auditor), of the facilities, equipment, systems, processes, procedures and personnel used in the manufacture of the chemical products (a GMP audit); and
 (b) demonstrate to the satisfaction of the APVMA that the holder is complying with the following conditions of the licence:
 (i) any conditions imposed on the licence under subsections 126(1) and (2) of the Code;
 (ii) the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition;
 (iii) any of the conditions mentioned in subregulations (3) to (7A) to which the licence is subject.
 (8A) For the purposes of a GMP audit, the holder of the licence:
 (a) must give the auditor access to all facilities, equipment, systems, processes, procedures and personnel used in the manufacture of the chemical products, and any information relevant to the GMP audit; and
 (b) must not conceal or withhold relevant information from the auditor.
 (8B) If the audit identifies a non‑conformance by the holder of the licence that, in the auditor's opinion, is a critical non‑conformance, the holder must notify the APVMA in writing of the critical non‑conformance within 3 working days of being told of the critical non‑conformance by the auditor.
 (8C) Following a GMP audit of the holder of a licence, the holder must:
 (a) within the period determined by the APVMA, give to the APVMA:
 (i) the original audit report, signed by the auditor,