National Health (Originator Brand) Amendment Determination 2022 (No. 1) (Cth)

PB 8 of 2022

National Health (Originator Brand) Amendment Determination 2022 (No. 1)

I, Nikolai Tsyganov, Acting Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make the following Determination.

Dated               27 January 2022  

NIKOLAI TSYGANOV

Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Schedules................................................................................................................................. 1

Schedule 1—Amendments  2

National Health (Originator Brand) Determination 2015 (PB 100 of 2015)   2

1  Name

This instrument is the National Health (Originator Brand) Amendment Determination 2022 (No. 1).

This instrument may also be cited as PB 8 of 2022.

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 February 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

This instrument is made under subsection 99ADB(6B) of the National Health Act 1953.

4  Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

1  Schedule 1, (after table item 63)

Insert:

63A Dimethyl fumarate Tecfidera

2  Schedule 1, (after table item 87)

Insert:

87A Fludrocortisone Florinef

3  Schedule 1, (after table item 97)

Insert:

97A Glatiramer Copaxone

4  Schedule 1, (after table item 140)

Insert:

140A Mefenamic acid Ponstan

5  Schedule 1, (after table item 142A)

Insert:

142B	Mesalazine	Pentasa	Rectal	Enemas 1 g in 100 mL, 7
Salofalk	Rectal	Enemas 2 g in 60 mL, 7
Salofalk	Rectal	Enemas 4 g in 60 mL, 7
Salofalk	Rectal	Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g
Salofalk	Rectal	Suppository (moulded) 1 g
Pentasa	Rectal	Suppository 1 g
Salofalk	Oral	Sachet containing granules, 500 mg per sachet
Salofalk	Oral	Sachet containing granules, 1 g per sachet
Pentasa	Oral	Sachet containing prolonged release granules, 1 g per sachet
Salofalk	Oral	Sachet containing granules, 1.5 g per sachet
Pentasa	Oral	Sachet containing prolonged release granules, 2 g per sachet
Salofalk	Oral	Sachet containing granules, 3 g per sachet
Pentasa	Oral	Sachet containing prolonged release granules, 4 g per sachet
Mesasal	Oral	Tablet 250 mg (enteric coated)
Salofalk	Oral	Tablet 500 mg (enteric coated)
Pentasa	Oral	Tablet 500 mg (prolonged release)
Asacol	Oral	Tablet 800 mg (enteric coated)
Salofalk	Oral	Tablet 1 g (enteric coated)
Pentasa	Oral	Tablet 1 g (prolonged release)
Mezavant	Oral	Tablet 1.2 g (prolonged release)
Asacol	Oral	Tablet 1.6 g (enteric coated)