Document ID: chunk:federal_register_of_legislation:F2024L00675:clause:2_4:p1
Version: federal_register_of_legislation:F2024L00675
Segment Type: clause
Provision Reference: sch 2 cl 4 (pt 1/2)
Character Range: 1786–4619

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) medicine;
(b) Secretary;
(c) shortage;
(d) sponsor.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
aggregated data set means data that is an aggregate of the individual data sets for a medicine from all data sources that provided data to the TGA for the medicine.
aggregated visual means the medicine availability modelling forecast (either in report form, live modelling form or any other form) for a medicine, that is created by the TGA or an expert adviser in the MAWG through the process of running the aggregated data set through a dynamic modelling process to obtain estimates of expected medicine availability.
alternative treatment means a medicine that may be used as an alternative for another medicine that is in shortage, is at risk of being in shortage, or has been permanently discontinued, for a patient who may be affected by the shortage or discontinuation of supply.
Australian Border Force has the same meaning as in the Australian Border Force Act 2015.
data source means any of the following:
 (a) a pharmacy;
 (b) a department or authority of a State or of a Territory;
 (c) a sponsor, or a peak body representing sponsors;
 (d) a wholesaler, or a peak body representing wholesalers;
 (e) a private hospital, or a peak body for the private hospital sector.
Foreign Affairs Department means the Department responsible for external affairs, including relations and communications with overseas governments and United Nations agencies, trade, and international development and aid.
Home Affairs Department means the Department responsible for border control (other than quarantine and inspection), border security and customs, and includes the Australian Border Force.
Industry Department means the Department responsible for manufacturing and commerce, biotechnology and the co-ordination of supply chain resilience policy.
individual data set means any data provided to the TGA by a data source for a medicine that is in shortage, is at risk of being in shortage, or has been permanently discontinued, and includes data about the following:
 (a) the supply of, or demand for, the medicine;
 (b) the current and expected availability of the medicine (including the quantity of the medicine);
 (c) when the medicine is expected to become available.
MAWG means the Medicine Availability Working Group, which:
 (a) is coordinated by the TGA; and
 (b) is comprised of representatives of State and Territory health departments; and
 (c) may include an expert adviser.
MSAG means a Medicine Shortage Action Group, which:
 (a) is convened and coordinated by the TGA for a medicine or a group of related medicines that are, or are anticipated to be in shortage or