Document ID: chunk:federal_register_of_legislation:F2018L01746:clause:2_4:p1
Version: federal_register_of_legislation:F2018L01746
Segment Type: clause
Provision Reference: sch 2 cl 4 (pt 1/2)
Character Range: 2180–5117

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) Register;
(c) registered goods;
(d) registration number;
(e) reportable medicine;
(f) shortage;
(g) sponsor.
  In this instrument:
  Act means the Therapeutic Goods Act 1989.
  active ingredient has the same meaning as in the Regulations.
  anticipated shortage, in relation to a medicine, means a shortage other than a current shortage.
  ATC means anatomical therapeutic chemical.
  ATC classification system means the Anatomical Therapeutic Chemical Classification System, an internationally accepted classification system for medicines that is maintained by the WHO and under which the WHO assigns ATC codes to all active ingredients contained in medicines based on the therapeutic indication for the medicine and classifies such ingredients into groups at 5 different levels according to the organ or system of the human body on which they act and the active ingredient's therapeutic, pharmacological and chemical properties, as in force or existing at 1 December 2018.
Note:  The ATC classification system can be found (and viewed for free) on the internet at:  https://www.whocc.no/atc_ddd_index_and_guidelines/atc_ddd_index/  (while there is a cost to obtain an electronic (200€) or paper (60€) version of the whole system, this website contains a free index which can be used to search for a medicine and view its ATC code without charge).
  critical impact, in relation to the discontinuation of the supply of a medicine, has the meaning given by subsections 30EG(2) and (3) of the Act.
  critical impact, in relation to the shortage of a medicine, has the meaning given by subsections 30EF(2) and (3) of the Act.
  current shortage, in relation to a medicine, means a shortage at a particular time if, at that time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.
  discontinuation decision has the meaning given by subsection 30EG(1) of the Act.
MSII means the voluntary Medicines Shortage Information Initiative that was administered by the Therapeutic Goods Administration for the period 2014 to 2018.
Note:  The Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration can be found (and viewed for free) on the internet at: http://www.tga.gov.au.
NIP means the National Immunisation Program Schedule as in force or existing at 1 December 2018.
Note:  The National Immunisation Program Schedule can be found (and viewed for free) on the internet at: http://beta.health.gov.au.
Regulations means the Therapeutic Goods Regulations 1990.
substitute medicine, in relation to a medicine which is in shortage or the subject of a discontinuation decision, means a