Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021
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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, including:
(a) Module 1 in accordance with eCTD AU module 1 and regional information v3.2, as in force or existing on 1 April 2025; and
(b) Modules 2 to 5 in accordance with ICH eCTD Specification v3.2.2, as in force or existing on 1 April 2025.
Note: The eCTD AU module 1 and regulation information v3.2 is published by the TGA on the TGA website at www.tga.gov.au. The ICH eCTD Specification v3.2.2. is published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and is available at www.ich.org.
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.