Part 1
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Commonwealth legislation
This Determination prescribes minimum stockholding levels for specified PBS brands and defines how to calculate a brand’s usual PBS demand (packs per month) from prior data-collection periods. It applies to suppliers of those PBS-listed brands who must hold the applicable quantity shown in Schedule 1, creating an inventory and compliance obligation tied to historical PBS supply data.
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Direct links to the current provisions in National Health (Minimum Stockholding) Determination 2023.
(1) This instrument is the National Health (Minimum Stockholding) Determination 2023. (2) This instrument may also be cited as PB 65 of 2023.
This instrument is made under subsection 99AEKC(2) of the National Health Act 1953.
In this instrument:
Act means the National Health Act 1953.
brand has the same meaning as in Part VII of the Act.
data collection period has the same meaning as in the National Health (Pharmaceutical Benefits) Regulations 2017.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
pharmaceutical item has the same meaning as in Part VII of the Act.
pricing quantity has the same meaning as in Part VII of the Act.
usual demand, when used in relation to a brand of a pharmaceutical item, means the usual demand for the brand of the pharmaceutical item within the meaning of section 99AEKC of the Act.
usual PBS demand, when used in relation to a brand of a pharmaceutical item, means the usual PBS demand for the brand of the pharmaceutical item ascertained in accordance with section 5.
(1) The usual PBS demand for a brand of a pharmaceutical item for a month in a data collection period for that brand is the number of packs of the brand supplied during the data collection period (the reference period) before the previous data collection period for the brand divided by the number of months in the reference period. (2) For the purposes of subsection (1) the number of packs of the brand supplied during a data collection period is taken to be: (a) the number of packs of the brand supplied as pharmaceutical benefits during that period; and (b) adjusted as if the size of the pack equals the pricing quantity of the brand. (3) For the purposes of this section, a brand of pharmaceutical item to which section 99ADHC and therefore 99AEKA of the Act applies, but to which section 99ADD of the Act does not apply, is treated as if data collection periods applied to the brand, and as if the start day for the first data collection period for the brand was the day on which that brand was first determined under subsection 85(6) of the Act.
For the purposes of subparagraphs 99AEKC(1)(a)(ii) and (1)(b)(ii) of the Act, if a brand of a pharmaceutical item is specified in an item of column 4 of the table in Schedule 1 to this instrument, the quantity ascertained in accordance with column 5 of that item is the applicable quantity of the brand of the pharmaceutical item.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(1) This instrument is the National Health (Minimum Stockholding) Determination 2023. (2) This instrument may also be cited as PB 65 of 2023.
This instrument is made under subsection 99AEKC(2) of the National Health Act 1953.
In this instrument:
Act means the National Health Act 1953.
brand has the same meaning as in Part VII of the Act.
data collection period has the same meaning as in the National Health (Pharmaceutical Benefits) Regulations 2017.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
pharmaceutical item has the same meaning as in Part VII of the Act.
pricing quantity has the same meaning as in Part VII of the Act.
usual demand, when used in relation to a brand of a pharmaceutical item, means the usual demand for the brand of the pharmaceutical item within the meaning of section 99AEKC of the Act.
usual PBS demand, when used in relation to a brand of a pharmaceutical item, means the usual PBS demand for the brand of the pharmaceutical item ascertained in accordance with section 5.
(1) The usual PBS demand for a brand of a pharmaceutical item for a month in a data collection period for that brand is the number of packs of the brand supplied during the data collection period (the reference period) before the previous data collection period for the brand divided by the number of months in the reference period. (2) For the purposes of subsection (1) the number of packs of the brand supplied during a data collection period is taken to be: (a) the number of packs of the brand supplied as pharmaceutical benefits during that period; and (b) adjusted as if the size of the pack equals the pricing quantity of the brand. (3) For the purposes of this section, a brand of pharmaceutical item to which section 99ADHC and therefore 99AEKA of the Act applies, but to which section 99ADD of the Act does not apply, is treated as if data collection periods applied to the brand, and as if the start day for the first data collection period for the brand was the day on which that brand was first determined under subsection 85(6) of the Act.
For the purposes of subparagraphs 99AEKC(1)(a)(ii) and (1)(b)(ii) of the Act, if a brand of a pharmaceutical item is specified in an item of column 4 of the table in Schedule 1 to this instrument, the quantity ascertained in accordance with column 5 of that item is the applicable quantity of the brand of the pharmaceutical item.