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COMMONWEALTHRegulation
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s 61A

Determination following GMP audit

In force
Part 7Manufacture of chemical products

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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