Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p7
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 7/12)
Character Range: 42259–45019

(2) or (3) of the Act for a variation that:
 (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
 (b) is of a kind specified in the changes table as an L(A)CN (section 9D) level change.
L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:
 (a) the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; 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 L(A)CN (section 23) level change.
medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).
mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.
mercury‑added products means the products listed in Part 1 of Annex A to the Minamata Convention that contain mercury, but does not include:
 (a) products essential for civil protection and military uses; or
 (b) products for research, calibration of instrumentation, or for use as reference standards; or
 (c) if no feasible mercury‑free alternative for replacement is available—the following:
 (i) switches and relays;
 (ii) cold cathode fluorescent lamps and external electrode fluorescent lamps for electronic displays;
 (iii) measuring devices; or
 (d) products used in traditional or religious practices; or
 (e) vaccines containing thiomersal as preservatives.
Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.
Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).
minimal manipulation: see regulation 3B.
mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.
N1 application has the meaning given by Part 1 of Schedule 9.
N2 application has the meaning given by Part 1 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