Document ID: chunk:federal_register_of_legislation:F2021L01466:clause:1_4:p1
Version: federal_register_of_legislation:F2021L01466
Segment Type: clause
Provision Reference: sch 1 cl 4 (pt 1/2)
Character Range: 2010–4794

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) biological;
(b) medicine;
(c) Register;
(d) registered goods.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
biosimilar means a medicine that is a biosimilar in relation to a registered medicine.
eCTD means the electronic Common Technical Document standard format in accordance with the Australian regional specification.
extension of indications medicine means a medicine that:
 (a) contains the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine included in the Register; and
 (b) has one or more indications in addition to that other medicine.
generic product has the same meaning as in the Regulations.
major variation has the same meaning as in clause 1 of Schedule 9 to the Regulations.
major variation medicine means a medicine that is taken to be separate and distinct from a registered medicine because of a major variation but does not include:
 (a) a new chemical entity medicine; or
 (b) a new biological entity medicine; or
 (c) a new biosimilar medicine; or
 (d) a new combination medicine; or
 (e) an extension of indications medicine; or
 (f) a new generic medicine; or
 (g) a new trade name medicine.
new biological entity medicine means a medicine that:
 (a) has not previously been included in the Register, and contains a biological substance; or
 (b) contains a biological substance mentioned in paragraph (c) of the definition of new chemical entity.
new biosimilar medicine means a medicine that has not previously been included in the Register and is a biosimilar in relation to a registered medicine.
new chemical entity has the same meaning as in clause 1 of Part 1 of Schedule 9 to the Regulations.
new chemical entity medicine means a medicine that contains a new chemical entity as mentioned in paragraphs (a), (b) and (d) of the definition of new chemical entity.
new combination medicine means a medicine that contains a new chemical entity as mentioned in paragraph (e) of the definition of new chemical entity.
new generic medicine means a medicine that has not previously been included in the Register and is a generic product.
new trade name medicine means a medicine that:
 (a) has the same active ingredient or active ingredients (or fixed combination of active ingredients) as a registered medicine; and
 (b) has the same indications as that other medicine; and
 (c) has the same dosage form as that other medicine; and
 (d) has been given a different name to that other medicine by the manufacturer, under which the medicine will be supplied.
registered medicine means a medicine that is included in the part