35A

Civil penalties relating to manufacturing therapeutic goods

Current

(1)

A person contravenes this subsection if:

(a)

the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and

(b)

the goods are for supply for use in humans; and

(c)

the goods are not exempt under section 18A or 32CB; and

(d)

none of the following applies:

(i)

the goods are exempt goods;

(ii)

the person is an exempt person in relation to the manufacture of the goods;

(iii)

the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises.

Maximum civil penalty:

(a)

for an individual—5,000 penalty units; and

(b)

for a body corporate—50,000 penalty units.

(2)

A person contravenes this subsection if:

(a)

the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and

(b)

the goods are for supply for use in humans; and

(c)

the goods are exempt under section 18A or 32CB; and

(d)

the person is not the holder of a licence that:

(i)

is in force; and

(ii)

authorises the carrying out of that step in relation to the goods at those premises.

Maximum civil penalty:

(a)

for an individual—5,000 penalty units; and

(b)

for a body corporate—50,000 penalty units.

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