Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p5
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 5/12)
Character Range: 37427–40197

16GJ; or
 (ii) a monograph contained in a default standard; and
 (b) an independent evaluation of the safety of the ingredient.
IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
in‑house IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
IVD device means an IVD medical device:
 (a) that is:
 (i) a Class 1 IVD medical device; or
 (ii) a Class 2 IVD medical device; or
 (iii) a Class 3 IVD medical device; or
 (iv) a Class 4 IVD medical device; and
 (b) that is not an in‑house IVD medical device.
IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
joint replacement medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).
L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:
 (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:
 (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and
 (ii) has the same pharmaceutical form; and
 (iii) is bioequivalent; and
 (iv) has the same safety and efficacy properties; or
 (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:
 (a) either:
 (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,