Commonwealth Consolidated Regulations

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AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 - REG 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.


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