THERAPEUTIC GOODS REGULATIONS 1990 - REG 43A When is no application fee payable?

THERAPEUTIC GOODS REGULATIONS 1990 - REG 43A

Certain applications to transfer entries of kinds of medical devices

  (2)   The applicable fee under item   2 or 3 in Part   2 of Schedule   9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection   41BD(3) of the Act.

Certain applications for the listing of medicines

  (4)   The fee under paragraph   (b) of item   3 of the table in Part   2 of Schedule   9 for an application for the listing of medicine is not payable if:

  (a)   the application is for the listing of medicine (the relisted medicine ) under section   26A of the Act; and

  (b)   the sponsor of the application holds a listing for medicine (the existing medicine ) that is the same as the relisted medicine, disregarding differences in relation to indications; and

  (c)   the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and

  (d)   the application is made before the end of 5   March 2021.