Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:45:p2
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 45 (pt 2/4)
Character Range: 419027–421769

goods of a kind mentioned in Part 1 of Schedule 10):
 (a) to register goods; or
 (aa) to list goods under section 26AE of the Act; or
 (b) in relation to registered goods that are a medicine—to vary the information entered in the Register; or
 (c) to include goods in the part of the Register for biologicals; or
 (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;
if the Secretary has information relating to the goods that enables the evaluation procedure to be abridged.

Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure
 (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary's opinion:
 (a) supply of the goods in Australia is necessary because of a public health emergency; and
 (b) the waiver or reduction is necessary to enable the goods to be supplied in Australia; and
 (c) the Secretary has information relating to the goods that allows the evaluation procedure to be abridged.

Waiver of application and evaluation fees—Medicines Repurposing Program
 (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:
 (a) the application is for an extension of indications of a registered medicine; and
 (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.
 (4AC) The Secretary may waive a fee under subregulation (4AB) on the Secretary's own initiative or on application.

Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure
 (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:
 (a) the medicine is a product of a kind specified in Part 1 of Schedule 10; and
 (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and
 (c) the Secretary is satisfied that:
 (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and
 (ii) neither non‑clinical nor quality data needs to be evaluated in the evaluation of the medicine for registration; and
 (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.
 (6) The Secretary may: