Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p6
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 6/12)
Character Range: 39955–42453

(i) the application requires an independent evaluation of the efficacy of the medicine; or
 (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and
 (b) the application is not an L(A)1 application or an L(A)2 application.
L(A)C1 (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
 (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
 (b) is of a kind specified in the changes table as an L(A)C1 (section 9D) level change.
L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:
 (a) the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
 (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
 (c) the change is of a kind specified in the changes table as an L(A)C1 (section 23) level change.
L(A)C2 (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
 (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
 (b) is of a kind specified in the changes table as an L(A)C2 (section 9D) level change.
L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:
 (a) the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
 (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
 (c) the change is of a kind specified in the changes table as an L(A)C2 (section 23) level change.
L(A)CN (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
 (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
 (b) is of a kind