EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 3)
PB 31 of 2012
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the Act, is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.
The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving treatment at or from a public or private hospital having access to appropriate specialised facilities.
This instrument makes changes to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commence on the same day.
This instrument:
- amends the circumstances associated with pharmaceutical benefits with the listed drug ‘Tocilizumab’ to include circumstances associated with treatment for patients with systemic juvenile idiopathic arthritis;
- adds a new listed brand “Pharmacor Mycophenolate 500’ for the listed drug ‘Mycophenolic acid’ in the form of ‘Tablet containing mycophenolate mofetil 500mg’ with manner of administration ‘Oral’;
- removes one pharmaceutical benefit with the listed drug ‘Darunavir’ in the form of ‘Tablet 300mg as ethanolate’ with manner of administration ‘Oral’ and brand ‘Prezista’; and
- removes one pharmaceutical benefit with the listed drug ‘Etravirine’ in the form of ‘Tablet 100mg’ with manner of administration ‘Oral’ and brand “intelence’.
This instrument also amends sections 24 and 25 of the Special Arrangement to add details for the maximum quantity and number of repeats associated with pharmaceutical benefits with the listed drug ‘Eltrombopag’, add details for the maximum quantity and number of repeats when the listed drug ‘Tocilizumab’ is used as treatment for patients with systemic juvenile idiopathic arthritis and make consequential changes to the description of the maximum quantity and number of repeats for the listed drug ‘Romiplostim’ as a result of the addition of ‘Eltrombopag’ for the same treatment condition.
This instrument also adds the listed drug ‘Eltrombopag’ to the list of CAR drugs.
This instrument also corrects minor inconsistencies in the wording of the authority required procedures as part of the circumstances associated with the following 18 listed drugs to ensure each circumstance has the appropriate authority required procedure: Abacavir with Lamivudine and Zidovudine, Adefovir, Darunavir, Deferasirox, Entecavir, Eltrombopag, Filgrastim, Interferon Alfa-2a, Interferon Alfa-2b, Lamivudine, Natalizumab, Pegfilgrastim, Peginterferon Alfa-2a, Ribavirin and Peginterferon Alfa-2b, Telbivudine, Tenofovir, Tenofovir with emtricitabine and efavirenz and Zoledronic Acid.
Consultation
The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.
PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
This Instrument commences on 1 May 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision by provision description of this Instrument is contained in the Attachment.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 3)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.3) and that it may also be cited as PB 31 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 May 2012.
Section 3 Amendments to PB 116 of 2010
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement).
Schedule 1
Items 1 to 3 amend Section 4 of the Special Arrangement by inserting ‘Eltrombopag’ into the definition of ‘CAR drug’.
Item 4 amends paragraph 24(2)g of the Special Arrangement by specifying that the maximum quantity applies only to the listed drug ‘Tocilizumab’ when used for the ‘treatment of adult patients with severe active rheumatoid arthritis’.
Items 5 to 8 amend paragraphs 24(2)(k), 24(2)(l), 24(2)(m) and 24(2)(n) of the Special Arrangement by specifying that the maximum quantities for the listed drug ‘Romiplostim’ applies to the initial or continuing treatment of severe thrombocytopenia ‘as the sole PBS-subsidised thrombopoetin receptor agonist (TRA)’ .
Item 9 amends section 24 of the Special Arrangement by adding details for the maximum quantity for the listed drugs ‘Eltrombopag’ and ‘Tocilizumab’ when used for the treatment of systemic juvenile idiopathic arthritis.
Items 10 to 13 amend paragraphs 25(2)(p), 25(2)(q), 25(2)(r) and 25(2)(s) by specifying that the number of repeats for the listed drug ‘Romiplostim’applies to the initial or continuing treatment of severe thrombocytopenia ‘as the sole PBS-subsidised thrombopoetin receptor agonist (TRA)’.
Item 14 amends section 25 of the Special Arrangement by adding details for the number of repeats for the listed drugs ‘Eltrombopag’and ‘Tocilizumab’ when used for the treatment of systemic juvenile idiopathic arthritis.
Item 15 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Darunavir’ by omitting a pharmaceutical benefit, which is the listed drug ‘Darunavir’ in the form ‘Tablet 300mg (as ethanolate)’ with the manner of administration ‘Oral’ and brand ‘Prezista’.
Item 16 amends the entries in Schedule 1 of the Special Arrangement for the listed drug ‘Eltrombopag’ by omitting the maximum quantities ‘28’ and number of repeats ‘5’ and inserting ‘See Note 1’ and ‘See Note 2’ for each entry.
Item 17 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Etravirine’ by omitting a pharmaceutical benefit, which is the listed drug ‘Etravirine’ in the form ‘Tablet 100mg’ with the manner of administration ‘Oral’ and brand ‘Intelence’.
Item 18 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Mycophenolic Acid’ by inserting one new pharmaceutical benefit, which is the listed drug ‘Mycophenolic Acid’ in the form ‘Tablet containing mycophenolate mofetil 500 mg’ with manner of administration ‘Oral’ and brand ‘Pharmacor Mycophenolate 500’.
Item 19 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Tocilizumab’ by inserting the circumstances codes ‘C4025’, ‘C4026’, ‘C4027’and ‘C4028’.
Item 20 amends Schedule 2 of the Special Arrangement by inserting the Responsible Person Code ‘CR’ and associated Responsible Person ‘Pharmacor Pty Limited’.
Items 21 and 22 amend Schedule 3 of the Special Arrangement for the listed drug ‘Abacavir with Lamivudine and Zidovudine’, circumstances codes ‘C3979’ and ‘C3980’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 23 amends Schedule 3 of the Special Arrangement for the listed drug ‘Abacavir with Lamivudine and Zidovudine’, circumstances code ‘C3981’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3981’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3981’.
Item 24 amends Schedule 3 of the Special Arrangement for the listed drug ‘Abacavir with Lamivudine and Zidovudine’, circumstances code ‘C3982’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3982’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3982’.
Items 25 and 26 amend Schedule 3 of the Special Arrangement for the listed drug ‘Adefovir’, circumstances codes ‘C3971’ and ‘C3972’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 27 amends Schedule 3 of the Special Arrangement for the listed drug ‘Adefovir’, circumstances code ‘C3973’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3973’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3973’.
Item 28 amends Schedule 3 of the Special Arrangement for the listed drug ‘Adefovir’, circumstances code ‘C3974’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3974’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3974’.
Item 29 amends Schedule 3 of the Special Arrangement for the listed drug ‘Darunavir’, circumstances code ‘C3940’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 30 amends Schedule 3 of the Special Arrangement for the listed drug ‘Darunavir’, circumstances code ‘C3941’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3941’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3941’.
Item 31 amends Schedule 3 of the Special Arrangement for the listed drug ‘Deferasirox’, circumstances code ‘C3828’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3828’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3828’.
Item 32 amends Schedule 3 of the Special Arrangement for the listed drug ‘Deferasirox’, circumstances code ‘C3829’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Items 33 to 36 amend Schedule 3 of the Special Arrangement for the listed drug ‘Eltrombopag’, circumstances codes ‘C3855’, ‘C3856’, C3857’ and ‘C3858’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with modified Authority Required procedures’.
Items 37 and 38 amend Schedule 3 of the Special Arrangement for the listed drug ‘Entecavir’, circumstances codes ‘C3959’ and ‘3960’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with modified Authority Required procedures’.
Item 39 amends Schedule 3 of the Special Arrangement for the listed drug ‘Entecavir’, circumstances code C3961, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3961’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3961’.
Item 40 amends Schedule 3 of the Special Arrangement for the listed drug ‘Entecavir’, circumstances code C3962, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3962’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3962’.
Item 41 amends Schedule 3 of the Special Arrangement for the listed drug ‘Entecavir’, circumstances code ‘C3963’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 42 amends Schedule 3 of the Special Arrangement for the listed drug ‘Entecavir’, circumstances code C3964, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3964’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3964’.
Item 43 amends Schedule 3 of the Special Arrangement for the listed drug ‘Entecavir’, circumstances code ‘C3965’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 44 amends Schedule 3 of the Special Arrangement for the listed drug ‘Entecavir’, circumstances code C3966, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3966’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3966’.
Item 45 amends Schedule 3 of the Special Arrangement for the listed drug ‘Filgrastim’, circumstances code ‘C3833’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 46 amends Schedule 3 of the Special Arrangement for the listed drug ‘Filgrastim’, circumstances code C3834, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3834’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3834’.
Items 47 and 48 amend Schedule 3 of the Special Arrangement for the listed drug ‘Interferon Alfa-2a’, circumstances codes ‘C3959’ and ‘C3960’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 49 amends Schedule 3 of the Special Arrangement for the listed drug ‘Interferon Alfa-2a’, circumstances code C3961, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3961’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3961’.
Item 50 amends Schedule 3 of the Special Arrangement for the listed drug ‘Interferon Alfa-2a’, circumstances code C3962, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3962’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3962’.
Items 51 and 52 amend Schedule 3 of the Special Arrangement for the listed drug ‘Interferon Alfa-2b’, circumstances codes ‘C3959’ and ‘C3960’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 53 amends Schedule 3 of the Special Arrangement for the listed drug ‘Interferon Alfa-2b’, circumstances code C3961, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3961’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3961’.
Item 54 amends Schedule 3 of the Special Arrangement for the listed drug ‘Interferon Alfa-2b’, circumstances code C3962, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3962’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3962’.
Items 55 and 56 amend Schedule 3 of the Special Arrangement for the listed drug ‘Lamivudine’, circumstances codes ‘C3586’ and ‘C3587’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 57 amends Schedule 3 of the Special Arrangement for the listed drug ‘Lamivudine’, circumstances code C3588, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3588’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3588’.
Item 58 amends Schedule 3 of the Special Arrangement for the listed drug ‘Lamivudine’, circumstances code C3589, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3589’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3589’.
Items 59 and 60 amend Schedule 3 of the Special Arrangement for the listed drug ‘Lamivudine’, circumstances codes ‘C3959’ and ‘C3960’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 61 amends Schedule 3 of the Special Arrangement for the listed drug ‘Lamivudine’, circumstances code C3961, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3961’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3961’.
Item 62 amends Schedule 3 of the Special Arrangement for the listed drug ‘Lamivudine’, circumstances code C3962, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3962’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3962’.
Item 63 amends Schedule 3 of the Special Arrangement for the listed drug ‘Natalizumab’, circumstances code ‘C3423’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with modified Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 64 amends Schedule 3 of the Special Arrangement for the listed drug ‘Pegfilgrastim’, circumstances code ‘C3833’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 65 amends Schedule 3 of the Special Arrangement for the listed drug ‘Pegfilgrastim’, circumstances code C3834, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3834’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3834’.
Items 66 and 67 amend Schedule 3 of the Special Arrangement for the listed drug ‘Peginterferon Alfa-2a’, circumstances codes ‘C3975’ and ‘C3976’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 68 amends Schedule 3 of the Special Arrangement for the listed drug ‘Peginterferon Alfa-2a’, circumstances code C3977, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3977’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3977’.
Item 69 amends Schedule 3 of the Special Arrangement for the listed drug ‘Peginterferon Alfa-2a’, circumstances code C3978, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3978’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3978’.
Item 70 amends Schedule 3 of the Special Arrangement for the listed drug ‘Ribavirin and Peginterferon Alfa-2b’, circumstances code C3413, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3413’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3413’.
Item 71 amends Schedule 3 of the Special Arrangement for the listed drug ‘Ribavirin and Peginterferon Alfa-2b’, circumstances code ‘C3948’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 72 amends Schedule 3 of the Special Arrangement for the listed drug ‘Ribavirin and Peginterferon Alfa-2b’, circumstances code C3949, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3949’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3949’.
Items 73 and 74 amend Schedule 3 of the Special Arrangement for the listed drug ‘Telbivudine’, circumstances codes ‘C3967’ and ‘C3968’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 75 amends Schedule 3 of the Special Arrangement for the listed drug ‘Telbivudine’, circumstances code ‘C3969’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3969’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3969’.
Item 76 amends Schedule 3 of the Special Arrangement for the listed drug ‘Telbivudine’, circumstances code ‘C3970’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3970’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3970’.
Items 77 and 78 amend Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances codes ‘C3586’ and ‘C3587’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 79 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances code ‘C3588’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3588’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3588’.
Item 80 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances code ‘C3589’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3589’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3589’.
Items 81 and 82 amend Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances codes ‘C3967’ and ‘C3968’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 83 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances code ‘C3969’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3969’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3969’.
Item 84 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances code ‘C3970’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3970’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3970’.
Items 85 and 86 amend Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances codes ‘C3971’ and ‘C3972’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 87 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances code ‘C3973’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3973’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3973’.
Item 88 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir’, circumstances code ‘C3974’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3974’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3974’.
Items 89 and 90 amend Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir with emtricitabine and efavirenz’, circumstances codes ‘C3983’ and ‘C3984’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 91 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir with emtricitabine and efavirenz’, circumstances code ‘C3985’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3985’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3985’.
Item 92 amends Schedule 3 of the Special Arrangement for the listed drug ‘Tenofovir with emtricitabine and efavirenz’, circumstances code ‘C3986’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3986’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3986’.
Item 93 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Tocilizumab’ by inserting the circumstances codes ‘C4025’, ‘C4026’, ‘C4027’and ‘C4028’ and the circumstances associated with them.
Item 94 amends Schedule 3 of the Special Arrangement for the listed drug ‘Zolendronic Acid’, circumstances code ‘C3881’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures’ and inserting ‘Compliance with Written or Telephone Authority Required procedures’.
Item 95 amends Schedule 3 of the Special Arrangement for the listed drug ‘Zolendronic Acid’, circumstances code ‘C3882’, by omitting from the column headed ‘Authority Requirements – Part of Circumstances’ ‘Compliance with Authority Required Procedures - Streamlined Authority Code C3882’ and inserting ‘Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code C3882’.