Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 22

Transfer of licences

  (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.

  (4A)   If a person who is the holder of a licence:

  (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 holder of the licence;

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 licence has effect as if it had been granted to the holder in the holder's new name.

  (5)   When a person notifies the Secretary of an event referred to in paragraph   (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), 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), (4)(d) or (4A)(a) or (b) 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), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.

 


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