Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:61a
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 61A
Character Range: 155019–156038

61A  Determination following GMP audit
 (1) For paragraph 6(2)(c) of the Act, this regulation applies if the holder of a licence is directed by the APVMA CEO to undergo a GMP audit under subregulation 61(8).
 (2) On receipt of the information mentioned in subregulation 61(8C), the APVMA must:
 (a) assess the information, having regard to the following:
  (i) whether the audit report identified any non‑conformances;
 (ii) whether any non‑conformances identified in the audit report have been rectified following corrective action;
 (iii) any other matters the APVMA considers relevant; and
 (b) determine whether the APVMA is satisfied 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 61(3) to (7A) to which the licence is subject.