Therapeutic Goods Regulations 1990

This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.

If the relevant person dies, the legal personal representative (the notifying person) of the dead person:

is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:

is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

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.

If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:

is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

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.

If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:

is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

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

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.

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 by the Secretary under subregulation (6), the Secretary must:

amend the Register accordingly; and

as soon as practicable after amending the Register:

inform the person of the amendment; and

make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.