Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:67:p1
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 67 (pt 1/3)
Character Range: 125344–128041

67  Exemptions

Exemptions for services—general
 (1) No fee is payable under this instrument for the provision of services if the submission or application for the services relates to:
 (a) a drug that is exempt from entry in the Australian Register of Therapeutic Goods because of an approval granted under section 19A of the Therapeutic Goods Act 1989; or
 (b) the supply of a drug, medicinal preparation or vaccine that the Secretary considers is necessary for the management of:
 (i) a public health event of national significance (within the meaning of the National Health Security Act 2007); or
 (ii) a biosecurity emergency that is declared to exist under subsection 443(1) of the Biosecurity Act 2015; or
 (iii) a human biosecurity emergency that is declared to exist under subsection 475(1) of the Biosecurity Act 2015.
 (2) No fee is payable under this instrument for the provision of services if the submission or application for the services seeks any of the following:
 (a) to offer a price reduction;
 (b) to change the name of the responsible person (as defined by subsection 84(1) of the Act) for a brand of a pharmaceutical item;
 (c) to vary a determination under subsection 9B(2) of the Act so that a vaccine ceases to be a designated vaccine;
 (d) to revoke a determination under subsection 9B(2) of the Act;
 (e) to vary a special arrangement under subsection 100(2) of the Act so that a drug or medicinal preparation ceases to be covered by the arrangement;
 (f) to revoke a special arrangement under subsection 100(2) of the Act;
 (g) to vary a declaration under subsection 101(4AAA) of the Act so that a drug or medicinal preparation ceases to be a listed drug;
 (h) to revoke a declaration under subsection 101(4AAA) of the Act;
 (i) to decrease the pack quantity (the existing pack quantity) of a listed brand of a pharmaceutical item if the amount that is to be the appropriate maximum price of the decreased pack quantity to be agreed under section 85AD of the Act will be calculated proportionally based on the approved ex‑manufacturer price of the existing pack quantity on the day before the agreement under that section takes effect;
 (j) to increase the pack quantity of a listed brand of a pharmaceutical item if the price for the increased pack quantity will be based on the proportional ex‑manufacturer price worked out under section 85D of the Act;
 (k) to vary a declaration, determination, arrangement or other legislative instrument made under section 9B or Part VII of the Act:
 (i) at the request of Services Australia or the Therapeutic Goods Administration; or
 (ii) that is a mandated change because of a Government initiative.
 (3) Subsections (1) and