Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 10AB

Application

  (1)   This regulation applies in relation to a person (the relevant person ) in relation to whom therapeutic goods are registered or listed.

Death of person

  (2)   If the relevant person dies, the legal personal representative (the notifying person ) 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 a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person

  (3)   If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person ) 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 a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate

  (4)   If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person ) 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 notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business

  (5)   If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person's interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person ) to whom the business or interest is transferred or assigned:

  (a)   is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

  (b)   must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.

Secretary may request further information

  (6)   If the notifying person notifies the Secretary of an event under paragraph   (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.

Secretary must amend the Register and provide new certificate

  (7)   If the notifying person notifies the Secretary of an event under paragraph   (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation   (6), the Secretary must:

  (a)   amend the Register accordingly; and

  (b)   as soon as practicable after amending the Register:

  (i)   inform the person of the amendment; and

  (ii)   make available to the person a certificate of registration or listing.