Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:61:p3
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 61 (pt 3/3)
Character Range: 153281–155017

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, and any associated audit report supplements; and
 (ii) details of the corrective action the holder proposes to take in relation to any non‑conformance identified in the audit report; and
 (iii) a proposed period for taking the corrective action; and
 (b) implement the corrective action within the period agreed to or specified by the APVMA; and
 (c) give to the APVMA evidence demonstrating 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.
 (9) If the holder of a licence:
 (a) changes his, her or its name; or
 (b) being a corporation that has amalgamated with another corporation, carries on business under a name that is different from the name of the holder stated on the licence;
the holder must give notice in writing to the APVMA of the new name, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.
 (10) If a body corporate that is the holder of a licence becomes a Chapter 5 body corporate, within the meaning of the Corporations Law, the person responsible for its administration must notify the APVMA, in writing, that the body corporate has become a Chapter 5 body corporate within 3 months after that occurrence.