Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) If a person in relation to whom therapeutic goods are registered or listed dies, the legal personal representative of the dead person:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must notify the Secretary, in writing, of the death not later than 3 months after it occurred.
(2) If a person in relation to whom therapeutic goods are registered or listed becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must notify the Secretary, in writing, of the bankruptcy not later than 3 months after the person became bankrupt.
(3) If a body corporate in relation to which therapeutic goods are registered or listed is being wound up, the liquidator of the body corporate:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.
(4) If:
(a) a person agrees to dispose of a business relating to the manufacture, distribution or sale of therapeutic goods; and
(b) it is agreed that the disposal of that business is to include a transfer of the registration or listing of therapeutic goods;
then:
(c) the person who acquires that business is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become the person in relation to whom the goods are to be registered or listed.
(4A) If a person in relation to whom therapeutic goods are registered or listed:
(a) changes his, her or its name; or
(b) being a corporation, amalgamates with another corporation under a name that is different from the name of the person in the Register;
the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.
(4B) The new name must be entered in the Register as the name of the person in relation to whom the therapeutic goods are registered or listed.
(5) When a person notifies the Secretary of an event referred to in paragraph (1) (b), (2) (b), (3) (b) or (4) (d) or subregulation (4A), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(6) If the Secretary is informed of the transfer of registration or listing of any therapeutic goods, or of the new name of a person and the circumstance giving rise to it, in accordance with this regulation, the Secretary must amend the Register accordingly.
(7) If, at any time, the Secretary becomes aware that he or she has not been informed of the transfer of registration or listing in respect of any therapeutic goods, or of the new name of a person and the circumstance giving rise to it, in accordance with this regulation, the Secretary may cancel the registration or listing of those goods.
(8) As soon as practicable after the Secretary has amended the Register in accordance with subregulation (6), the Secretary must give to the person in whose name the goods are registered or listed a certificate of registration or listing of the goods.
(9) If the Secretary:
(a) amends the Register in accordance with subregulation (6); or
(b) cancels the registration or listing of goods under subregulation (7);
the person who has the certificate issued under subsection 25 (4) or 26 (4) of the Act or subregulation (8) must return it as soon as practicable to the Secretary.
Penalty: 5 penalty units.
(10) An offence under subregulation (9) is an offence of strict liability.
Note For strict liability , see section 6.1 of the Criminal Code .