Determination following GMP audit
61A Determination following GMP audit
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).
On receipt of the information mentioned in subregulation 61(8C), the APVMA must:
assess the information, having regard to the following:
whether the audit report identified any non‑conformances;
whether any non‑conformances identified in the audit report have been rectified following corrective action;
any other matters the APVMA considers relevant; and
determine whether the APVMA is satisfied that the holder is complying with the following conditions of the licence:
any conditions imposed on the licence under subsections 126(1) and (2) of the Code;
the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition;
any of the conditions mentioned in subregulations 61(3) to (7A) to which the licence is subject.
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