Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p8
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 8/12)
Character Range: 44815–47677

of Schedule 9.
N3 application has the meaning given by Part 1 of Schedule 9.
N4 application has the meaning given by Part 1 of Schedule 9.
N5 application has the meaning given by Part 1 of Schedule 9.
new dosage form medicine means a medicine that:
 (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and
 (b) has an indication in common with that other medicine; and
 (c) does not have the same dosage form as that other medicine.
new indications medicine means a prescription medicine that:
 (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and
 (b) does not have the same indications as that other medicine.
new prescription medicine means a prescription medicine that contains:
 (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or
 (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.
nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:
 (a) a standard applicable to the biological; or
 (b) any manufacturing requirements under the Act for the biological.
non‑Minamata mercury means any of the following:
 (a) mercury to be used for laboratory‑scale research or as a reference standard;
 (b) naturally occurring trace quantities of mercury present in:
 (i) products such as non‑mercury metals, ores or mineral products (including coal); or
 (ii) products derived from the products mentioned in subparagraph (i);
 (c) unintentional trace quantities of mercury in chemical products.
open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.
Note: For container, see Act, subs 3(1).
original cells or tissues: see regulation 3B.
OTC medicine means therapeutic goods mentioned in Part 3 of Schedule 10.
pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlements Act 1986.
Poisons Standard has the same meaning as current Poisons Standard.
Practice Guideline has the meaning given by paragraph 12AB(2)(a).
principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.
quarter means a period of 3 months commencing on 1 January, 1 April, 1 July or 1 October in a year.
RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if