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Name of Determination
1 Name of Determination
(1) This Determination is the National Health (Originator Brand) Determination 2015. (2) This Determination may also be cited as PB 100 of 2015.
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This instrument sets which brand names count as "originator brands" for the PBS by naming them in a Schedule lookup table. Originator status can be limited by route (e.g., oral) and form (e.g., tablet), and any drug that's an "exempt item" under section 99ADA cannot be an originator. It matters because originator designation affects patient costs and pharmacy reimbursement for generics.
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Direct links to the current provisions in National Health (Originator Brand) Determination 2015.
(1) This Determination is the National Health (Originator Brand) Determination 2015. (2) This Determination may also be cited as PB 100 of 2015.
In this Determination:
Act means the National Health Act 1953.
(1) For subsection 99ADB(6B) of the Act, unless subsections (2) or (3) of this section apply, an originator brand specified in column 3 of an item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2 of the same item in Schedule 1. (2) Where a manner of administration is specified in column 4 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 1, with the manner of administration specified in column 4 of the same item in Schedule 1. (3) Where a form is specified in column 5 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 in the form specified in column 5 of the same item in Schedule 1.
Note: A brand of an exempt item is not an originator brand due to section 99ADA of the Act.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(1) This Determination is the National Health (Originator Brand) Determination 2015. (2) This Determination may also be cited as PB 100 of 2015.
In this Determination:
Act means the National Health Act 1953.
(1) For subsection 99ADB(6B) of the Act, unless subsections (2) or (3) of this section apply, an originator brand specified in column 3 of an item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2 of the same item in Schedule 1. (2) Where a manner of administration is specified in column 4 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 1, with the manner of administration specified in column 4 of the same item in Schedule 1. (3) Where a form is specified in column 5 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 in the form specified in column 5 of the same item in Schedule 1.
Note: A brand of an exempt item is not an originator brand due to section 99ADA of the Act.