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RASML Update Required Advisory Statements for Medicine Labels Update 3.1 Record of Decisions and Reasons Historical document April 2008 Required Advisory Statements for Medicine Labels –Update 3.1 Record of Decisions and Reasons PURPOSE This document is to record changes to the Required Advisory Statements for Medicine Labels (edition 1, including update 2) dated April 2006 (RASML) and to provide details of reasons for decision. All the changes included in this update are results of: • TGA review of NSAIDs and Medicines Evaluation Committee (MEC) recommendations; or • Decisions by the National Drugs and Poisons Schedule Committee (NDPSC) to amend the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) entries for Vitamin A and Selenium and Complementary Medicines Evaluation Committee (CMEC) recommendations; or • Black cohosh safety review; or • CMEC recommendations which have been accepted by the TGA; or • Formalisation of RASML in inclusion of advisory statements that the TGA and Complementary Medicines Industry have longstanding agreement. AMENDMENTS Introductory Sections No changes proposed in this update. Section 1 – Medicines to Which Advisory Statements Apply Summary of Proposed Changes Changes are proposed as follows: HistoricalSubstance documentChange Type Diclofenac (Entry 1 of 2) Amendment Diclofenac (Entry 2 of 2) Amendment Flurbiprofen New Entry Ibuprofen (Entry 1 of 4) Amendment Ibuprofen (Entry 2 of 4) Amendment RASML – UPDATE 3.1 – Record of Decisions and Reasons Substance Change Type Ibuprofen (Entry 3 of 4) Amendment Ibuprofen (Entry 4 of 4) Amendment Ketoprofen (Entry 1 of 2) New Entry Ketoprofen (Entry 2 of 2) New Entry Mefenamic acid (Entry 1 of 2) Amendment Mefenamic acid (Entry 2 of 2) Amendment Naproxen (Entry 1 of 2) Amendment Naproxen (Entry 2 of 2) Amendment High selenium yeast Amendment Selenium yeast - high Amendment Selenocysteine Amendment Selnomethionine Amendment Sodium selenate Amendment Sodium selenite Amendment Yeast - high selenium Amendment Vitamin A Amendment Cimicifuga racemosa Amendment Larrea tridentata New Entry Zingiber officinale New Entry Glucosamine hydrochloride New Entry Glucosamine sulfate potassium chloride complex New Entry (Entry 1 of 2) Glucosamine sulfate potassium chloride complex New Entry (Entry 2 of 2) Glucosamine sulfate sodium chloride complex New Entry Glucosamine sulphate New Entry Propolis (Entry 1 of 2) New Entry Propolis (Entry 2 of 2) New Entry Royal jelly New Entry Shark cartilage New Entry Phenylalanine New Entry Caffeine (Entry 1 of 2) New Entry HistoricalCaffeine (Entry 2 of 2) documentNew Entry Polygonum multiflorum New Entry 2 RASML – UPDATE 3.1 – Record of Decisions and Reasons The tables below show: • the entry being amended (including headings where appropriate for reference purposes and showing text to be deleted in blue and strikethrough); • the amended/new entry (inserted details in blue and underlined). Note that underlining is used to highlight the changes made in this document is and is not required on the label itself; • the reasons for the decision to amend/include the entry; and • transitional arrangements. Medicines Which Meet The Following Conditions ... Require Statement(s) Gazettal Date Containing Entry text Diclofenac When: (126, 127, 128, 5 April 2006 j (Entry 1 of 2) (a) included in a Schedule to the 149, 130) SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Amended Diclofenac When: (126, 127, 149, 23 April 2008 130, 159, 160 j entry (Entry 1 of 2) (a) included in a Schedule to the ) SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Entry text Diclofenac When: (126, 18, 127, 5 April 2006 128 (Entry 2 of 2) (a) included in a Schedule to the , 149, 130, 133)j SUSDP; and (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Amended Diclofenac When: (126, 18, 127, 23 April 2008 149, 130, 133, entry (Entry 2 of 2) (a) included in a Schedule to the 159, 160)j SUSDP; and (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decisionHistorical recommendations. document Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal. 3 RASML – UPDATE 3.1 – Record of Decisions and Reasons Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry Amended Flurbiprofen When included in a Schedule to the (126, 127, 23 April 2008 entry SUSDP. 18, 149, 130, 133, j 159, 160) Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC entry recommendations. Statements 18, 126, 130, 133 and 149 are included to harmonise with similar non-selective NSAIDs. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal. Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Ibuprofen For the purpose of exclusion from the 126, 127, 5 Apr 2006 Schedules to the SUSDP, when the 128 (Entry 1 of 4) , 151, preparation is for oral use and is 130, 131, indicated exclusively for the treatment 132 of dysmenorrhoea. Amended Ibuprofen For the purpose of exclusion from the 126, 127, 23 April 2008 entry (Entry 1 of 4) Schedules to the SUSDP, when the 151, 130, preparation is for oral use and is 131, 132, indicated exclusively for the treatment 159, 160 of dysmenorrhoea. Entry text Ibuprofen For the purpose of exclusion from the 126, 18, 5 Apr 2006 (Entry 2 of 4) Schedules to the SUSDP, when the 127, 128, preparation is for oral use and is NOT 151, 130, indicated exclusively for the treatment 131, 132, of dysmenorrhoea. 133 Amended Ibuprofen For the purpose of exclusion from the 126, 18, 23 April 2008 entry (Entry 2 of 4) Schedules to the SUSDP, when the 127, 151, preparation is for oral use and is NOT 130, 131, indicated exclusively for the treatment 132, 133, Historicalof dysmenorrhoea. document159, 160 4 RASML – UPDATE 3.1 – Record of Decisions and Reasons Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Ibuprofen When: (126, 127, 23 Jun 2004 128, 149, (Entry 3 of 4) (a) included in a Schedule to the 130)j SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Amended Ibuprofen When: (126, 127, 23 April 2008 149, 130, entry (Entry 3 of 4) (a) included in a Schedule to the 159, 160)j SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Entry text Ibuprofen When: (126, 18, 23 Jun 2004 127, 128, (Entry 4 of 4) (a) included in a Schedule to the SUSDP; and 149, 130, 133)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Amended Ibuprofen When: (126, 18, 23 April 2008 127, 149, entry (Entry 4 of 4) (a) included in a Schedule to the 130, 133, SUSDP; and 159, 160)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decision recommendations. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal. Historical document 5 RASML – UPDATE 3.1 – Record of Decisions and Reasons Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry Amended Ketoprofen When: (126, 127, 23 April 2008 entry (Entry 1 of 2) 149, 130, (a) included in a Schedule to the j 159, 160) SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Ketoprofen When: (126, 127, 23 April 2008 (Entry 2 of 2) (a) included in a Schedule to the 149, 18 130, SUSDP; and 133, 159, j 160) (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decision recommendations. Statements 18, 126, 130, 133 and 149 are included to harmonise with similar non-selective NSAIDs. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal. Medicines Which Meet The Following Conditions.. Require Gazettal Date Containing Statement(s) Entry text Mefenamic When: (126,127, 23 Jun 2004 acid 128, 149, (a) included in a Schedule to the j (Entry 1 of 2) SUSDP; and 130) (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Amended Mefenamic When: (126, 127, 23 April 2008 acid 149, 130, entry (a) included in a Schedule to the 159, 160 j (Entry 1 of 2) SUSDP; and ) (b) the preparation is indicated exclusively for the treatment of Historicaldysmenorrhoea. document 6 RASML – UPDATE 3.1 – Record of Decisions and Reasons Medicines Which Meet The Following Conditions.. Require Gazettal Date Containing Statement(s) Entry text Mefenamic When: (126, 18, 23 Jun 2004 acid 127, 128 (a) included in a Schedule to the , (Entry 2 of 2) SUSDP; and 149, 130, 133)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Amended Mefenamic When: (126, 18, 23 April 2008 acid 127, 149, entry (a) included in a Schedule to the 130, 133, (Entry 2 of 2) SUSDP; and 159, 160)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea.
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