61ADetermination following GMP audit

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.