Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p1
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 1/12)
Character Range: 27188–30033

2  Interpretation
  In these Regulations, unless the contrary intention appears:
active ingredient, for a medicine, means a therapeutically active component in the medicine's final formulation that is responsible for its physiological or pharmacological action.
AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.
analysis includes examination and testing.
antiseptic means a substance:
 (a) that is recommended by its manufacturer for:
 (i) dermal application; or
 (ii) application to the mucous membranes of a person or an animal:
 (A) to kill micro organisms; or
 (B) to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
 (b) that is not represented to be suitable for internal use.
Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.
Note 1: The Australian Approved Names List includes:
(a) Australian Approved Names—Chemicals List; and
(b) Australian Approved Names—Biological Lists; and
(c) the Herbal Substances AAN List.
Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.
authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.
Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.
biological medicine means:
 (a) a medicine (other than an antibiotic) that is:
 (i) a vaccine, a peptide, a protein or polysaccharide‑based; and
 (ii) derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and
 (iii) of a kind specified in item 1 of Part 1 of Schedule 10; or
 (b) a medicine that is a human blood product of a kind mentioned in Appendix A in Part 5 of the Poisons Standard.
biologicals (priority applicant) determination has the meaning given by subsection 32DEA(2) of the Act.
C1 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C1 (section 23) application has the meaning given by Part 1 of Schedule 9.
C2 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C2 (section 23) application has the meaning given by Part 1 of Schedule 9.
C3 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C3 (section 23) application has the meaning given by Part 1 of Schedule 9.
C4 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C4 (section 23) application has the meaning given by Part 1