Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p11
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 11/12)
Character Range: 52380–55239

the change is of a kind specified in the changes table as an RCMC3 (section 23) level change.
RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.
RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:
 (a) the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
 (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
 (c) the change is of a kind specified in the changes table as an RCMC4 (section 23) level change.
Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.
sample includes part of a sample.
serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:
 (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or
 (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.
specialist has the same meaning as in the Health Insurance Act 1973.
sporicide means a chemical agent that:
 (a) kills bacterial spores; and
 (b) has the potential to act as a sterilising agent after prolonged contact with an inanimate object.
sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.
submission has the meaning given by subclause 1(2) in Part 1 of Schedule 9.
TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).
Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration's website (http://www.tga.gov.au).
the Act means the Therapeutic Goods Act 1989.
Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.
therapeutic goods (priority applicant) determination has the meaning given by subsection 25AAA(2) of the Act.
therapeutic vaping device has the same meaning as in the Therapeutic