THERAPEUTIC GOODS ACT 1989 - SECT 42T Notifying of actual or potential tampering

THERAPEUTIC GOODS ACT 1989 - SECT 42T

  (1)   A person commits an offence if:

  (a)   the person supplies, manufactures or is a sponsor of, or proposes to supply, manufacture or become a sponsor of, therapeutic goods; and

  (b)   either:

  (i)   the person knows that some or all of those therapeutic goods, or any other therapeutic goods, are or have been subject to actual or potential tampering; or

  (ii)   some or all of those therapeutic goods, or any other therapeutic goods, are or have been subject to actual or potential tampering, and the person is reckless as to that fact; and

  (c)   the person fails, within 24 hours after becoming aware of, or becoming aware of a substantial risk of, the actual or potential tampering, to notify the Secretary.

Penalty:   Imprisonment for 12 months or 1,000 penalty units, or both.

Note:   For the liability of an executive officer of a body corporate, see sections   54B and 54BA.

  (2)   A person commits an offence if:

  (a)   the person supplies, manufactures or is a sponsor of, or proposes to supply, manufacture or become a sponsor of, therapeutic goods; and

  (b)   the person receives information or a demand; and

  (c)   either:

  (i)   the person knows that the information or demand relates (either expressly or by implication) to actual or potential tampering with some or all of those therapeutic goods, or any other therapeutic goods; or

  (ii)   the information or demand relates (either expressly or by implication) to actual or potential tampering with some or all of those therapeutic goods, or any other therapeutic goods, and the person is negligent as to that fact; and

  (d)   the person fails to notify the Secretary of the information or demand within 24 hours after receiving it.

Penalty:   Imprisonment for 12 months or 1,000 penalty units, or both.

Note:   For the liability of an executive officer of a body corporate, see sections   54B and 54BA.

  (3)   For the purposes of subparagraph   (2)(c)(ii), the person is only taken to be negligent as to the fact that the information or demand is of the kind referred to in that subparagraph if:

  (a)   the person's acts or omissions involve such a great falling short of the standard of care that a reasonable person would exercise in the circumstances; and

  (b)   there is such a high risk that the information or demand is of that kind;

that the acts or omissions merit criminal punishment.

  (4)   For the purposes of this section, it does not matter whether, at the time of receipt of the information or demand:

  (a)   the person has possession or control of the therapeutic goods to which the information or demand relates; or

  (b)   the therapeutic goods are in existence.