Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - REG 22

22. (1) If a person who was the holder of a licence dies, the legal personal
representative of the dead person:

   (a)  is taken to be the holder of the licence; and

   (b)  must notify the Secretary, in writing, of the death not later than 3
        months after it occurred.

(2) If a person who is the holder of a licence becomes bankrupt, the trustee
in bankruptcy of the estate of the bankrupt:

   (a)  is taken to be the holder of the licence; 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 that is the holder of a licence is being wound up, the
liquidator of the body corporate:

   (a)  is taken to be the holder of the licence; 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 a licence held by that person; then:

   (c)  the person who acquires that business is taken to be the holder of the
        licence; 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
        an applicant for the licence.

(5) When a person notifies the Secretary of an event referred to in paragraph
(1) (b), (2) (b), (3) (b) or (4) (d), the person must send to the Secretary
sufficient documentary evidence to establish the matter asserted in the
notification.

(6) When a person is taken to be the holder of a licence in accordance with
this regulation, the Secretary may regard the person as an applicant for the
licence and may deal with the notification referred to in paragraph (1) (b),
(2) (b), 3 (b) or (4) (d) as if it were an application for a licence.

(7) In spite of subregulation (6), a person who is regarded as an applicant
for a licence because of the operation of that subsection may continue to
manufacture therapeutic goods under the original licence until the application
is determined.

(8) If, at any time, the Secretary becomes aware that he or she has not been
informed in accordance with this regulation of an event referred to in
paragraph (1) (b), (2) (b), (3) (b) or (4) (b), the Secretary may cancel the
licence to which the event relates.