Attachment 1: Expanded List of Permitted Indications

Therapeutic Goods Administration Attachment 1: Expanded list of permitted indications Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context1 Antioxidant Oral 0AO-00-US-00-S00 SAN082 Traditionally used in herbal medicine as Topical 0AT-MI-US-00-THM HC a mild antiseptic3 Helps strengthen bone and tissue in growing and mature users.Oral 0BS-00-SN-00-SCO CALC24Helps in the development and Oral 0BT-00-DM-HE-S00 HC maintenance of bones and teeth5 Helps in the development and maintenance of bones and teeth Oral 0BT-00-DM-HE-SCA HC especially in childhood, adolescence and young adulthood6 Helps maintain cell health Oral 0CE-HE-MA-HE-S00 FNFC7 Helps in connective tissue formation Oral 0CT-00-FO-HE-S00 HC8 Helps to produce and repair connective Oral 0CT-00-PD-HE-S00 HC tissue9 Helps strengthen connective tissue Oral 0CT-00-SN-HE-S00 BM1710 Supports energy production Oral 0EY-00-PR-SU-S00 SAN10Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 1 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context11 Helps to support a modest reduction in fat mass when used with a program of Oral 0FM-MR-SU-HE-S00 HC reduced intake of dietary calories and increased physical activity12 Supports foetal growth and development Oral 0FO-GD-SU-00-S00 SAN1213 Contributes to the normal growth of the Oral 0FO-GR-CO-00-S00 FNFC foetus14 Assists in the maintenance of normal healthy blood sugar/glucose balance in Oral 0GB-NH-MA-AS-S00 BLDGL03 healthy individuals.15 Assists in the maintenance of normal healthy glycaemic controls in healthy Oral 0GC-NH-MA-AS-S00 BLDGL02 individuals.16 Helps normal growth and development Oral 0GD-NO-HE-00-S00 HC17 Assists in the maintenance of normal healthy blood sugar/glucose levels in Oral 0GL-NH-MA-AS-S00 BLDGL01 healthy individuals.18 Used in herbal medicine as supportive Warning HS, therapy for the promotion of healthy Oral 0GL-HE-PR-SU-NHM HC BSL required glucose levels 19 Used in Traditional Chinese Medicine (TCM) to relieve gum, mouth and throat Warning S Oral 0GM-CO-RE-00-TCM HC complaints20 Helps normal growth Oral 0GR-NO-HE-00-S00 HC21 Helps improve general health / well Oral 0HE-GE-IM-00-S00 WELL1 being22 Helps maintain general health / well Oral 0HE-GE-MA-00-S00 WELL2 being Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context23Promotes general health. Oral 0HE-GE-PR-0-S00 PERI324For the maintenance of good health Oral 0HE-GO-MA-00-S00 HC25 Provides antioxidants for the Oral 0HE-GO-MA-AO-S00 HC maintenance of good health 26 Helps in the maintenance of good health Oral 0HE-GO-MA-HE-S00 HC27 Used in Traditional Chinese Medicine Warning S (TCM) to support the healing of minor Topical 0IN-00-HE-PR-TCM HC required injuries28 Warning S Helps reduce minor inflammation Oral 0IN-00-RD-HE-S00 SAN07 required29Traditionally used in herbal medicine to Warning S Topical 0IN-MI-SO-HE-THM HC help soothe minor inflammation required30 Helps to maintain healthy mucosa Oral 0MC-HE-MA-HE-S00 SAN15/FNFC31 Traditionally used in herbal medicine as Oral 0MC-RG-SS-TO-T00 HC a tonic to strengthen and soothe the mucous tissue of both respiratory and gastro-intestinal tractAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 3 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context32 Beneficial to men in satisfying physiological requirements of the male Oral 0ME-00-BE-00-S00 MALE2 body.33 Balances and supports normal male Oral 0ME-00-BS-00-S00 MALE1 reproductive function.34 Traditionally used in Ayurveda for HS Oral 0ME-00-EN-00-TAY HC memory enhancement 35 Helps to enhance memory in adults HS Oral 0ME-00-EN-HE-SAD HC36 Nutritional and herbal support designed Oral 0ME-00-SE-00-S00 MALE3 to supply masculine needs.37 Increases [fat-free/body/muscle/lean] [mass/size] when used in conjunction Oral 0MM-00-IN-00-S00 HC with a resistance training regimen and a healthy energy-controlled diet38 Helps to assist in muscle cell repair after Oral 0MU-CR-AS-HE-S00 HC exercise39 Helps to maintain proper muscle Oral 0MU-FU-MA-HE-S00 HC function40 Assists in the management of the symptoms of over-indulgence such as Oral 0OI-00-MG-AS-S00 GAST11 indigestion, constipation, bloating and fatigue.41 Relieves the symptoms of overindulgence such as indigestion, Oral 0OI-SY-RE-00-S00 GAST6 constipation, bloating and fatigue42 Used in herbal medicine to help enhance Oral 0PC-00-EN-HE-NHM HC physical capacity/performance in cases of physical stress Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context43Traditionally used in Ayurveda to relieve Warning S Topical 0PI-00-RE-HE-TAY HC pain and minor inflammation required44 Traditionally used in herbal medicine as a galactogogue/lactogogue to help Oral 0PS-MI-PR-HE-THM HC promote milk production/secretion45Used in Traditional Chinese Medicine Oral 0QI-00-RI-00-TCM HC (TCM) to reinforce qi (vital energy)46 Used inTraditional Chinese Medicine (TCM) to promote circulation of qi (vital Oral 0QI-CI-PR-00-TCM HC energy)47Used in Traditional Chinese Medicine (TCM) for deficiency of qi (vital energy) Warning S, and yin, internal heat, cough, cools heat COU1 & COU2 Oral 0QI-DE-US-00-TCM HC from yin deficiency, tiredness, dry and required thirsty mouth and throat48 Used in Traditional Chinese Medicine Oral 0QI-FL-PR-00-TCM HC (TCM) to promote the flow of qi (vital energy)Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 5 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context49 Used in Traditional Chinese Medicine (TCM) to augment the protective Qi Warning S (vital energy) and stabilize the exterior: Oral 0QI-PR-AG-00-TCM HC required for deficiency with spontaneous sweating50 Traditionally used in Ayurveda as Oral 0RA-00-US-00-TAY HC Rasayana (rejuvenative tonic) 51 Used as a sleep aid Oral 0SL-00-AI-00-N00 HC52 Traditionally used in Ayurveda as a Oral 0SL-00-AI-00-TAY HC sleep aid53 Traditionally used in herbal medicine as Oral 0SL-00-AI-00-THM HC a mild sedative and/or sleep aid54 Traditionally used in herbal medicine as Oral 0SL-00-AI-00-TWH HC a sleep aid55 Helps to promote sleep Oral 0SL-00-PR-HE-S00 HC56 Traditionally used in herbal medicine as Oral 0SL-00-PR-HE-THM HC a sleep aid to help promote sleep57 Traditionally used in herbal medicine as Oral 0SL-CA-AI-00-THM HC a calmative and/or sleep aid58 Traditionally used in herbal medicine as a sleep aid (in cases of restlessness or Oral 0SL-RI-AI-00-S00 HC insomnia due to mental stress)59 Traditionally used in herbal medicine as Oral 0SL-RI-AI-00-THM HC a sleep aid (in cases of restlessness or Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context insomnia due to stress)60 Traditionally used in Traditional Chinese Medicine (TCM) to support the healing Topical 0SO-00-HE-PR-TCM HC of minor sores61Herbal medicinal product in conditions in which easy defaecation with soft stool Oral 0SS-00-US-00-NHM EMA is desirable62 Improves stamina and endurance Oral 0ST-00-IM-00-S00 SAN1363 Traditionally used in herbal medicine to Oral 0SW-00-IN-00-T00 HC induce sweating64 Traditionally used in herbal medicine to Oral 0SW-00-IN-00-THM HC induce sweating (diaphoretic)65 Traditional herbal medicinal product for Warning S Topical 0SW-EX-RE-00-THM EMA relief of excessive sweating required66 Traditional herbal medicinal product for Warning S Topical 0SW-SM-MG-00-THM EMA management of small superficial wounds required67 Helps in tissue formation Oral 0TI-00-FO-HE-S00 HC68 Used in Traditional Chinese Medicine Topical 0TI-00-RE-PR-TCM HC (TCM) to support tissue regeneration69 Used in herbal medicine as a nutritive Oral 0TO-NU-US-00-NHM HC tonic70 Traditionally used in herbal medicine as Oral 0TO-NU-US-00-THM HC a nutritive tonic Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 7 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context71Traditionally used in Ayurveda to balance aggravated Vata (nervine tonic, Oral 0VA-AG-BA-00-TAY HC sedative)72 Assists in the maintenance of general Oral 0WB-GE-MA-AI-S00 WELL well-being73 Used in Traditional Chinese Medicine Warning S Oral 0WD-00-DI-00-TCM HC (TCM) to dispel wind-dampness required74Traditionally used in herbal medicine to Topical 0WH-00-AI-00-THM HC aid in wound healing75 Helps in wound healing Oral 0WH-00-HE-00-S00 HC76Traditional used in herbal medicine as Topical 0WH-MI-AI-00-THM EMA an aid in the healing of mild sunburn77 Traditionally used in herbal medicine to Topical 0WH-MI-AS-00-THM HC assist in minor wound healing78 Additional Assists weight loss by suppression of statement as appetite in conjunction with (or as part per guidelines Oral 0WM-AP-SP-00-SWM WGHT of) a kilojoule/calorie controlled eating eg has not been plan shown to cause weight loss79 To be used with a program of reduced Additional Oral 0WM-CA-RD-00-SWM HC intake of dietary calories and increased statement as physical activity to help in weight per guidelines management by reducing carbohydrate eg has not been cravings shown to cause Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context weight loss80Traditionally used in herbal medicine to support elimination (alterative) via the Oral 0WP-AC-RE-HE-THM HC kidneys, skin and mucus membranes81 Warning DIAR Relieves diarrhoea Oral A09-00-RE-00-S00 DIAR2 required82 Traditionally used in herbal medicine to Warning DIAR Oral A09-00-RE-HE-THM HC help relieve diarrhoea required83 Warning DIAR Assists in the management of diarrhoea Oral A09-00-MG-AS-S00 DIAR/1/2 required84 Used in herbal medicine as an astringent Warning DIAR Oral A09-AS-RE-HE-NHM HC and to help relieve diarrhoea required85Traditionally used in herbal medicine as Warning DIAR Oral A09-AS-RE-HE-THM HC an astringent to help relieve diarrhoea required86Traditionally used in herbal medicine as Warning DIAR Oral A09-DE-RE-HE-THM HC a demulcent to help relieve diarrhoea required87 Traditional herbal medicinal product for Warning DIAR Oral A09-MI-MG-SY-THM EMA symptom management of mild diarrhoea requiredAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 9 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context88 Helps to reduce the recurrence of cold Warning S Oral B00-RE-RD-HE-S00 HC sores required89 Warning S Relieves the symptoms of cold sores Topical B00-SY-RE-00-S00 CSOR/INFEC1 required90 Relief of the pain of medically diagnosed Warning S2 SHING1 shingles by topical application. required Topical B02-PA-RE-00-STA91 Relief of the itching of medically Warning S2 SHING2 diagnosed shingles by topical required Topical B02-IT-RE-00-STA application. 92 Warning S Wart remover (Not Genital Warts) Topical B07-00-RE-00-N00 HC required93 Relieves the symptoms associated with Warning S Topical B07-00-RE-SY-S00 INFEC3 warts (NOT GENITAL WARTS) required94 Traditionally used in herbal medicine to Warning S help remove warts (NOT GENITAL Topical B07-HF-RE-HE-THM HC required WARTS)95 Warning S Relief of tinea by topical application. Topical B35-00-RE-00-S00 TINEA1 required96 Relieves the symptoms of superficial Warning S Topical B35-FI-RE-00-S00 FUNG1 fungal infections (topical) required97 For the management of superficial Warning S Topical B35-00-MG-00-S00 FUNG1 fungal infections (topical) required98 Used in herbal medicine to help relieve Warning S the symptoms of superficial fungal Topical B35-SY-RE-HE-NHM HC required infections (topical)99 Warning S Relieves the symptoms of athletes foot Topical B35-SA-RE-00-S00 TINEA4 required100 Warning S Relieves the symptoms of tinea Topical B35-SY-RE-00-S00 TINEA3 required101 For the management of tinea by topical Warning S Topical B35-TI-MG-00-S00 TINEA2 application. required102 Warning S Helps expel worms Oral B82-00-EX-HE-S00 WORM required103 Relieves the symptoms of scabies by Warning S Topical B86-SY-RE-00-S00 SCAB Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context topical application required104 Relieves the symptoms of papilloma (not Warning S Topical B97?-SY-RE-00-S00 INFEC2 genital warts) required105 Helps to prevent dietary Vitamin B12 Oral D51-00-PV-HE-S00 HC deficiency106 Assists blood circulation Oral DBL-CI-SU-00-S00 BLOOD1107These claims are appropriate for folic acid – Used as a blood tonic to help maintain vitamin B12 and BLOOD2/FOLIC1/2/IRON1/VB121/VB Oral DBL-NO-MA-AS-S00 normal blood iron – but must 122 not imply anaemic conditions108 Used as a blood tonic. Oral DBL-TO-US-00-S00 IRON2VB122Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 11 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context109 Helps support immune system health Oral DHE-PS-SU-HE-S00 HC after periods of physical stress110Necessary for the formation of haemogloblin, which transports oxygen Oral DHG-00-FO-NE-S00 IRON5 to the tissues111Helps to maintain immune function Oral DIM-FU-MA-HE-S00 HC112 Used in herbal medicine to help maintain Oral DIM-HE-MA-HE-NHM HC a healthy immune system113Traditionally used in herbal medicine to Oral DIM-HE-MA-HE-THM HC support a healthy immune system114 Supports a healthy immune system Oral DIM-HE-SU-00-S00 SAN09115Helps to form red blood cells Oral DRC-00-FO-HE-S00 HC/FNFC Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context116 Helps proper function of red blood cells Oral DRC-00-PF-HE-S00 HC117Used in Traditional Chinese Medicine Oral DSL-00-BE-00-TCM HC (TCM) to benefit the spleen and lung118Used in Traditional Chinese Medicine (TCM) to tonify the spleen and augment Warning S the Qi (vital energy): for spleen Oral DSP-00-TO-00-TCM HC required deficiency presenting with a lack of appetite, fatigue, and diarrhoea119 Prevention of dietary vitamin [XX] NS1 VIT1 deficiency.Oral E56-ND-PV-00-S00120 Prevention of dietary mineral [YY] NS1 deficiency.Oral E56-ND-PV-00-MIN121 For the management of medically NS1 VIT1 confirmed vitamin [XX] deficiency (This indication is not be to used for the treatment of iron deficiency conditions). Oral E56-ND-MG-00-S00122 For the management of medically NS1 confirmed dietary mineral [YY] deficiency (This indication is not be to Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 13 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context used for the treatment of iron deficiency conditions).123 Assists in the prevention of dietary iron Warning NS1 IRON6 deficiency. Oral E61-ID-PV-AS-S00124 Helps prevent symptoms of lactose Warning S intolerance (including gas, bloating, Oral E73-SY-PV-HE-S00 HC required cramping and diarrhoea). 125 Assists in the maintenance of normal Oral EBF-NO-MA-AS-S00 BLDFAT01 blood fat levels in healthy individuals126 Assists in the maintenance of normal Oral EBL-NO-MA-AS-S00 BLDFAT01 blood lipid levels in healthy individuals127VIT advisory Helps calcium absorption statement Oral ECA-00-AB-HE-S00 VITD required128 Helps in the absorption and utilisation of Oral ECA-00-AU-HE-S00 HC calcium129 Promotes calcium absorption Oral ECA-00-PR-00-S00 SAN06130 Promotes the intestinal absorption of Oral ECA-AB-PR-00-S00 FNFC calcium131 Helps the body to metabolize Oral ECB-00-ME-HE-S00 HC carbohydrates 132 Helps to reduce intestinal absorption of Warning CHL Oral ECH-IA-RD-HE-S00 CHOL05 cholesterol from dietary sources. required133 Assists in the maintenance of normal/healthy cholesterol levels in Oral ECH-NH-MA-AS-S00 CHOL02 healthy individuals.134 Assists in the maintenance of cholesterol Oral ECH-NR-MA-AS-S00 CHOL01 within the normal range in healthy individuals. Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context135 Helps reduce the oxidation of LDL Warning CHL Oral ECH-OX-RD-HE-S00 CHOL06 cholesterol. required136Assists in the improvement of the Warning CHL Oral ECR-00-IM-AS-S00 CHOL03 LDL:HDL ratio. required137 Assists in the maintenance of a Warning CHL normal/healthy LDL:HDL cholesterol Oral ECR-NH-MG-AS-S00 CHOL04 required ratio.138 Helps the body to metabolise fats Oral EFA-00-ME-HE-S00 HC139 Aids the emulsification and/or digestion Oral EFA-DI-AI-00-S00 DIG6 of fats in the intestine140 Helps restore plasma glutamine levels depleted after periods of physical stress Oral EGL-PS-RS-HE-S00 HC (e.g. prolonged exhaustive exercise) 141 Provides support for healthy glucose Warning BSL Oral EGM-HE-SU-PR-S00 HC metabolism required142 Helps in the absorption and utilisation of Oral EPH-00-AU-HE-S00 HC phosphorus143 Helps the body to metabolise proteins Oral EPR-00-ME-HE-S00 HC144 Helps the body to sythesize proteins Oral EPS-00-IN-00-S00 HC145 Supports normal/healthy thyroid Oral ETF-HE-SU-00-S00 BM08 function146 Helps in the function of the thyroid Oral ETG-00-FU-HE-S00 HC gland. Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 15 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context147 Assists in the maintenance of triglycerides within the normal range in Oral ETG-NO-MA-AS-S00 BLTRIG01 healthy individuals.148 The NHMRC recommends that for healthy men and women, drinking no more than two Assists in the management of hangover standard drinks Oral F10-HO-MG-AS-S00 HANG2 on any day reduces the lifetime risk of harm from alcohol-related disease or injury.149 The NHMRC recommends that for healthy men and women, drinking no more than two Relieves the symptoms of hangover standard drinks Oral F10-SY-RE-00-S00 HANG1 on any day reduces the lifetime risk of harm from alcohol-related disease or injury.150 Relief of mood swings associated with Warning S NERV14 Oral F38-PT-RE-00-S00 Premenstrual tension. required151 Relief of mood swings associated with Warning S NERV14 Oral F38-MP-RE-00-S00 Menopause. required152 Assists in the management of mood Warning S NERV17 swings associated with Premenstrual required Oral F38-PT-MG-AS-S00 tension. 153 Assists in the management of mood Warning S Oral F38-MP-MG-AS-S00 NERV17 swings associated with Menopause. required154 Helps relieve mild anxiety. Warning S NERV1 required Oral F41-00-RE-HE-S00155 Relieves the symptoms of mild anxiety. Warning S NERV13 Oral F41-SY-RE-00-S00 required156 Assists in the management of mild Warning S NERV16 anxiety. required Oral F41-00-MG-AS-S00157 Helps relieve stress. Warning S NERV1 required Oral F43-00-RE-HE-S00 Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context158 Relieves symptoms of stress Warning S NERV15/18 required Oral F43-SY-RE-00-S00159 Traditionally used in herbal medicine to Warning S Oral F51-00-RE-HE-THM HC help relieve headaches required160 Traditionally used in herbal medicine to Warning S Oral F51-GA-EA-HE-S00 HC help ease (gastric) headaches required161 Warning S Relieves insomnia Oral F51-IN-RE-00-S00 SLEEP2 required162 Warning S Relieves sleeplessness Oral F51-SL-RE-00-S00 SLEEP1 required163 Helps to enhance cognitive function in Oral FCF-00-EN-HE-SAD HC adults164Used in herbal medicine to help support Oral FCF-00-SU-HE-NHM HC cognitive function165 Helps to support cognitive function in Oral FCF-00-SU-HE-S00 HC healthy people166 Helps support cognitive health Oral FCH-00-SU-HE-S00 HC167 Used in herbal medicine to help promote Oral FMB-HE-PR-HE-NHM HC healthy mood balance 168 Helps to promote healthy mood balance Oral FMB-HE-PR-HE-S00 HC169 Improve and maintain memory HS Oral FME-00-IM-00-S00 BM07170 Helps to temporarily promote relaxation Oral FRE-00-PR-HE-S00 HC171 Warning S Assists in the management of migraine Oral G43-00-MG-AS-S00 MIGR4 requiredAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 17 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context172Traditional herbal medicinal product for the prophylaxis of migraine headaches Oral G43-00-PR-00-THM EMA after serious conditions have been excluded by a medical doctor173 Used in herbal medicine to help prevent Oral G43-00-PV-HE-NHM HC migraine headaches174 Warning S Temporary relief of migraine headache. Oral G43-00-RE-TE-S00 MIGR required175 Warning S Helps reduce the frequency of migraines. Oral G43-FR-RD-00-S00 MIGR2 required176 Helps reduce the frequency of migraine Warning S headaches and associated nausea and Oral G43-FR-RD-HE-SPR HC required vomiting when taken as a prophylactic177 Helps reduce the severity and duration Warning S of migraine headaches when taken as a Oral G43-SD-RD-HE-SPR HC required prophylactic178Used in herbal medicine to help reduce the severity and/or frequency of Warning S migraine headaches and associated Oral G43-SF-RD-HE-NPR HC required symptoms such as nausea and vomiting, when taken as a prophylactic179 Relieves the symptoms of tension Warning S Oral G44-SY-RE-00-S00 MIGR3 headache required180 Assists in the management of tension Warning S Oral G44-TH-MG-AS-S00 MIGR5 headache required181 Temporary relief of neuralgic headache. Warning S HEAD2 Oral G44-NE-RE-TE-S00 required182 Herbal medicinal product for the relief of Warning S Oral G47-00-RE-00-NHM EMA sleep disorders required183 Used in herbal medicine to help relieve Warning S Oral G47-MI-RE-HE-NHM HC Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context sleep disturbances associated with mild required anxiety184 Helps to reduce the time it takes to fall asleep (sleep onset latency aspect of Sublingual/ G47-SL-RD-HE-S00 HC sleep quality) in people with delayed Oral sleep phase syndrome185 Relieves the symptoms of medically Warning S2 CTS1 diagnosed carpal tunnel syndrome required Oral G56-SY-RE-00-S00186 Assists in the management of medically Warning S2 CTS2 diagnosed carpal tunnel syndrome required Oral G56-00-MG-AS-S00187 Relieves the symptoms of medically Warning S2 CFS1 diagnosed chronic fatigue syndrome. required Oral G93-SY-RE-00-S00188 Assists in the management of medically Warning S2 CFS2 diagnosed chronic fatigue syndrome. required Oral G93-00-MG-AS-S00189 Helps support the development of the Oral GBR-00-DE-SU-SCH HC brain in children up to 12 years of age 190 Helps support brain function Oral GBR-FU-SU-HE-S00 HC191 Supports healthy functioning of the Oral GFU-HE-SU-00-S00 BM03 nervous system192 Helps support the development of the Oral GNE-00-DE-SU-SCH HC nerves in children up to 12 years of age 193 Helps re-set the body's sleep-wake cycle Sublingual/ GSC-CR-RT-HE-S00 HC (aspect of the circadian rhythm) Oral Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 19 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context194 Helps increase the total sleep time (aspect of sleep quality) in people Sublingual/ suffering from sleep restriction or GST-TO-IN-HE-SSW HC Oral altered sleep schedule , e.g. Shift work and jet lag195 Assists visual fatigue and eye-strain Ophthalmic H53-00-AS-00-S00 EYE1196 Helps eyes adapt to variations in light Ophthalmic H53-LI-AD-HE-S00 EYE3 intensity197 Relieves the symptoms of tinnitus Warning S EAR3 Oral H93-SY-RE-00-S00 required198 Assists in the management of tinnitus Warning S EAR6 required Oral H93-00-MG-AS-S00199Traditionally used in herbal medicine for the temporary relief of eye discomfort Warning S Ophthalmic HDI-00-RE-TE-THM HC/EMA due to dryness of the eye or to exposure required to wind or sun200Helps to maintain eyesight Oral HES-00-MA-HE-S00 HC201 Helps support the development of the Oral HEY-00-DE-SU-SCH HC eyes in children up to 12 years of age 202 Helps maintain healthy eyes Oral HEY-HE-MA-HE-S00 EYE5/SAN14203 Supports eye health HEY-HE-SU-00-S00 SAN14 Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context204 Relief of the soreness and inflammation Warning S Ophthalmic HEY-SI-RE-00-S00 EYE6 associated with minor eye conditions required205 Assists in the management of watery or Warning S Ophthalmic HEY-WI-MG-AS-S00 EYE9 itchy eyes required206 Warning S Relieves watery or itchy eyes Ophthalmic HEY-WI-RE-00-S00 EYE7 required207 Supports healthy eye function Ophthalmic HFU-EY-SU-00-S00 EYE2208Helps in the development and Oral HVI-NI-DM-HE-S00 HC maintenance of night vision209 Involved in rod vision Ophthalmic HVI-RO-IN-00-S00 EYE4210Traditionally used in herbal medicine as Warning S an astringent to relieve symptoms of Oral I83-AS-RE-00-THM HC required damaged veins211 Relieves aching legs associated with Warning S VEIN1 varicose veins. required Oral I83-AL-RE-00-S00Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 21 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context212 Assists in the management of varicose Warning S VEIN2 veins. required Oral I83-00-MG-AS-S00213 Temporary relief of the symptoms of Warning S VEIN3 varicose veins. required Oral I83-SY-RE-TE-S00214 Helps relieve swelling, heaviness, pain Warning S and itching of the legs associated with Topical I83?-SY-RE-00-S00 BM14 required varicose veins215 Relief of the discomfort of medically Warning S2 HAEM1 diagnosed haemorrhoids by local required Topical I84-DI-RE-00-S00 application. 216 Assists in the management of medically Warnings S2 HAEM2 diagnosed haemorrhoids by softening AND LAX1 Oral I84-SM-MG-AS-S00 bowel motions required217Herbal medicinal product for the management of medically diagnosed chronic venous insufficiency, which is Warning S2 characterised by swollen legs, varicose Oral I87-00-MG-00-NHM EMA required veins, a feeling of heaviness, pain, tiredness, itching, tension and cramps in the calves218Used in herbal medicine to help relieve symptoms related to non-complicated medically diagnosed chronic venous Warning S2 Oral I87-SY-RE-HE-NHM HC insufficiency (CVI), such as sensation of required swelling, heaviness and tingling of the legs219 Helps to relieve symptoms related to non-complicated medically diagnosed Warning S2 chronic venous insufficiency (CVI), such Oral I87-SY-RE-HE-S00 HC required as sensation of swelling, heaviness and tingling of the legs220 Used in herbal medicine to help manage Warning S2 Oral I87-SY-MG-HE-NHM HC medically diagnosed chronic venous required Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context insufficiency and associated symptoms221 Helps to support healthy arteries Oral IAR-HE-SU-HE-S00 BM09222 Maintains proper blood circulation Oral IBC-PR-MA-00-S00 FNFC223Used in Traditional Chinese Medicine Oral IBL-BS-EL-00-TCM HC (TCM) to eliminate blood stasis224 Assists in the maintenance of normal Oral IBP-NO-MA-AS-S00 BLOODP01 blood pressure in healthy individuals.225 Help to support normal blood pressure Oral IBP-NO-SU-HE-S00 BLOODP02 in healthy individuals.226 Protects the integrity of capillary walls Oral ICA-IN-PT-00-S00 BLOOD3227 Protects capillaries from oxidating Oral ICA-OA-PT-00-S00 BLOOD3 agents228 Helps maintain healthy capillaries Oral ICA-HE-MA-HE-S00 BLOOD4229 Traditional herbal medicinal product to relieve symptoms of discomfort and Warning S heaviness of legs related to minor Oral/Topical ICD-DH-RE-00-THM EMA required venous circulatory disturbances such as varicose veins230 Assists peripheral circulation Oral ICI-PE-AS-00-S00 BLOOD7231 Assists in the maintenance of peripheral Warning S Oral/Topical ICI-PE-MA-AA-S00 PERI1/2/3 circulation to relieve cold hands and feet. required232 Helps maintain blood circulation to the Oral/Topical ICI-PE-MA-HE-S00 BLOOD5/6 peripheral areas of the body such as the legs, hands and feet Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 23 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context233Traditional herbal medicinal product Warning S [used] as an adjuvant in the relief of Topical ICI-PE-RE-AD-THM EMA required minor peripheral circulatory disorders234 Helps to support healthy peripheral Oral/Topical ICI-PE-SU-HE-S00 HC circulation 235 Traditionally used in herbal medicine to Oral ICI-PE-SU-HE-THM HC help support peripheral circulation236 Helps to support the cardiovascular Oral ICV-FU-SU-HE-S00 HC system 237 Used in herbal medicine to help maintain Oral ICV-HE-MA-HE-NHA HC cardiovascular health in adults238 Helps maintain cardiovascular health Oral ICV-HE-MA-HE-S00 HC239 Traditionally used in herbal medicine to help maintain cardiovascular health in Oral ICV-HE-MA-HE-THA HC adults240 Used in herbal medicine to help support Oral ICV-HE-SU-HE-NHA HC cardiovascular health in adults241 Helps support cardiovascular health Oral ICV-HE-SU-HE-S00 HC242 Traditionally used in herbal medicine to help support cardiovascular health in Oral ICV-HE-SU-HE-THA HC adults243 Helps support a modest improvement in Oral IEC-MO-SU-HE-SCV HC exercise capacity in individuals with stable cardiovascular diseases (CVD) Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context244 Used in herbal medicine to help in the Warnings S & management of mild upper respiratory Oral J00-00-FO-HE-NHM HC COLD required tract infections245 Assists in the management of mild upper Warnings S & Oral J00-MI-MG-AS-S00 COLD10 respiratory tract infections COLD required246 Traditionally used in herbal medicine to Warnings S & help relieve minor inflammation of the Oral J00-00-RE-HE-THM HC COLD required mucous membranes of the mouth/throat247 Helps to shorten the duration of upper Warnings S & respiratory tract infections (e.g. common Oral J00-00-SH-HE-S00 HC COLD required cold) 248 Supportive therapy in the management Warnings S & of mild upper respiratory tract infections Oral J00-00-MG-SU-S00 HC COLD required (e.g. Common colds)249 Traditional herbal medicinal product for Warnings S & Oral J00-00-MG-SU-THM EMA supportive management of common cold COLD required250 Herbal medicinal product traditionally Warning S, used to relieve symptoms of sore throat COLD, COU1 & Oral J00-CC-RE-00-NHM EMA associated with dry cough and cold COU2 required251 Traditionally used in herbal medicine to Warning S, Oral J00-CI-RE-HE-THM HC help relieve coughs and irritation of the COLD, COU1 & throat in colds and catarrh of the COU2 required respiratory tractAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 25 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context252 Warnings S & Helps reduce the duration of colds Oral J00-DR-RD-00-S00 COLD5 COLD required253 Herbal medicinal product traditionally Warnings S & used for the relief of early symptoms of Oral J00-ES-RE-00-THM EMA COLD required the common cold254 Helps reduce the frequency of common Warnings S & Oral J00-FR-RD-HE-S00 SAN11 colds COLD required255 Warnings S & Oral J00-IN-RE-00-S00 COLD9 Relieves the symptoms of mild upper COLD required respiratory tract infections.256 Helps reduce the severity and duration Warnings S & Oral J00-SD-RD-00-S00 COLD6 of colds COLD required257 Warnings S & Helps reduce the severity of colds Oral J00-SV-RD-00-S00 COLD4 COLD required258 Warnings S & Helps reduce the severity of the Oral J00-SV-RD-HE-S00 COLD2 COLD required symptoms of colds. 259 Warnings S & Oral J00-SY-RE-00-S00 COLD1 Relieves the symptoms of colds. COLD required260 Traditional herbal medicinal product for Warning S, the relief of symptoms in coughs and COLD, COU1 & Cutaneous J00-SY-RE-00-THM EMA colds COU2 required261 Helps to relieve the symptoms of mild Warning S & upper respiratory tract infections (e.g. Oral J00-SY-RE-HE-S00 HC COLD required common cold) 262Traditionally used in herbal medicine to Warning S & Oral J00-SY-RE-HE-THM HC help relieve cold symptoms COLD required263 Assists in the management of colds Warnings S and FLU5 Oral J00-00-MG-AS-S00 COLD required264 Assists in the management of sinusitis Warning S Oral J01-00-MG-AS-S00 SINUS4 required Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context265 Warning S Relieves sinus pain Oral J01-PA-RE-00-S00 SINUS2 required266 Warning S Relieves the symptoms of sinusitis Oral J01-SY-RE-00-S00 SINUS1/3 required267 Assists in the management of acute Warning S Oral J02-00-MG-AS-S00 THROA2 pharyngitis/sore throat required268 Temporary relief of cough and sore Warning S Oral J02-SY-RE-TE-S00 COU3 throat by relaxing the cough reflex required269Traditionally used in herbal medicine to Warning S Oral/Buccal J02-00-RE-HE-THM HC help relieve sore throat required270 Traditionally used in herbal medicine as Warning S Oral J02-AS-RE-HE-THM HC an astringent to help relieve sore throats required271Traditionally used in herbal medicine as Warning S Oral J02-DE-RE-HE-THM HC a demulcent to help relieve sore throat required272Traditional herbal medicinal product for Warning S, use as a demulcent preparation for the COU1 & COU2 Oral J02-DE-RE-SY-THM EMA relief of symptoms of oral or pharyngeal required irritation and associated dry cough273 Used in herbal medicine to help relieve Warning S Buccal J02-MI-RE-HE-NHM HC mild inflammations of the mucous required membranes of the mouth and/or throat Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 27 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context274 Traditional herbal medicinal product for Warning S Topical/Oro the relief of symptoms of minor J02-MT-RE-SY-THM EMA required mucosal inflammations in the mouth or throat275 Warning S Relieves the symptoms of sore throat Oral J02-SY-RE-00-S00 THROA1 required276 Relieves the symptoms of medically Warning S2 TONS1 diagnosed tonsillitis. required Oral J03-SY-RE-00-S00277 Relief of the pain of medically diagnosed Warning S2 TONS3 tonsillitis. required Oral J03-PA-RE-00-S00278 Relieves the discomfort of medically Warning S2 TONS4 diagnosed tonsillitis. required Oral J03-DI-RE-00-S00279 Relief of the discomfort associated with Warning S Oral J04-DI-RE-00-S00 LARYN4 laryngitis. required280 Relief of the inflammation associated Warning S Oral J04-IN-RE-00-S00 LARYN2 with laryngitis. required281 Relief of the pain associated with Warning S Oral J04-PA-RE-00-S00 LARYN3 laryngitis. required282 Relieves the symptoms associated with Warning S Oral J04-SY-RE-00-S00 LARYN1 laryngitis. required283 Helps shorten the duration of mild upper Warnings S & Oral J06-DU-RD-HE-S00 HC respiratory tract infections COLD required284 For the management of mild upper Warnings S & Oral J06-IN-MG-00-S00 RESP2/3 respiratory tract infections COLD required285 Relieves the symptoms of mild upper Warnings S & respiratory tract infections (e.g., Oral J06-MI-RE-00-S00 RESP1 COLD required common cold) Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context286 Assists in the management of the Warnings S & symptoms of mild infections of upper Oral J06-SY-MG-AS-S00 RESP4 COLD required respiratory tract287 Relieves the symptoms of recurrent mild Warnings S & Oral J06-SY-RE-00-S00 RESP5 upper respiratory tract infections COLD required288 Helps to relieve the symptoms of mild Warnings S & Oral J06-SY-RE-HE-S00 HC upper respiratory tract infections COLD required289 Traditionally used in herbal medicine to help relieve the symptoms associated Warning S & Oral J06-SY-RE-HE-THM HC with mild upper respiratory tract COLD required infections and catarrhal conditions290 Relieves the symptoms of colds and flu. Warnings S and FLU1 Oral J11-SY-RE-00-S00 COLD required291 Assist in the management of colds and Warnings S and FLU2 flu (by reducing the severity and COLD required duration of symptoms). Oral J11-SD-MG-AS-S00292 Relief of the pain of colds and flu. Warnings S and FLU3 Oral J11-PA-RE-00-S00 COLD required293 Relief of the fever of colds and flu. Warnings S and FLU4 Oral J11-FE-RE-00-S00 COLD required294 Assists in the management of colds and Warnings S and FLU5 Oral J11-00-MG-AS-S00 flu. COLD required295 Warning S Assists in the management of rhinitis Oronasal J30-00-MG-AS-S00 ALLER4 required296Used in herbal medicine to help relieve Warning S Oral J30-SY-RE-00-NHM HC seasonal allergy symptoms required297 Warning S Relieves the symptoms of hayfever Oronasal J30-SY-RE-00-S00 HAYF requiredAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 29 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context298 Warning S Relieves the symptoms of rhinitis Oronasal J31-SY-RE-00-S00 ALLER2 required299 Warning S Relieves the symptoms of catarrh Oral JCA-SY-RE-00-S00 CATAR required300 Warning S, Relieves the symptoms of coughs and COLD, COU1 & Topical JCC-SY-RE-00-S00 EMA colds COU2 required301Used in herbal medicine to help relieve minor inflammation and/or irritation of Warning S Buccal JII-MI-RE-HE-NHM HC the mucous membranes of the mouth required and/or throat302 Assists in the management of mild upper Warning S & respiratory tract infections (e.g., Oral JIN-MI-MG-AS-S00 RESP6 COLD required common cold)303 Used in Traditional Chinese Medicine Warning S & (TCM) to tonify the lungs and for Oral JLU-00-TO-00-TCM HC COLD required frequent colds 304 Used as a decongestant to relieve nasal Warning S Oral JNC-00-RE-00-N00 HC congestion required305 Used in herbal medicine as a Warning S decongestant/to relieve nasal Oral JNC-00-RE-00-NHM HC required congestion306 Relieves mucous congestion by drying Warning S Nasal JNC-00-RE-00-S00 NASAL the secretion of the nose (decongestant) required307 Warning S & Relieves mucous congestion Oral JNC-CC-RD-00-S00 COLD7/MUC COLD required308 Used as a decongestant to relieve nasal Warning S & Oral JNC-CC-RE-00-N00 HC congestion (due to the common cold) COLD required309 Used in herbal medicine as a Warning S & Oral JNC-CC-RE-00-NHM HC decongestant to relieve nasal congestion COLD required Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context(due to the common cold)310 Used to relieve nasal congestion (due to Warning S & Oral JNC-CC-RE-00-S00 HC the common cold) COLD required311 Used as a decongestant to relieve Warning S & Oral JNC-DE-US-00-S00 HC symptoms of a chest cold COLD required312 Used as a decongestant to relieve nasal Warning S & congestion (due to hay fever/allergic Oral JNC-HF-RE-00-N00 HC COLD required rhinitis/allergies)313 Used in herbal medicine as a decongestant to relieve nasal congestion Warning S & Oral JNC-HF-RE-00-NHM HC (due to hay fever/allergic COLD required rhinitis/allergies)314 Used as a decongestant to relieve nasal Warning S & Oral JNC-SI-RE-00-N00 HC congestion (due to sinusitis) COLD required315 Used in herbal medicine as a Warning S & decongestant to relieve nasal congestion Oral JNC-SI-RE-00-NHM HC COLD required (due to sinusitis)316 Traditionally used in Herbal Medicine to Oral JRS-00-SN-00-T00 HC support the respiratory system317 Assists in the prevention of dental caries Buccal K02-00-PV-AS-S00 DENT7318 Helps prevent tooth decay Buccal K02-00-PV-HE-S00 DECAY319 Traditional herbal medicinal product for Warning S the temporary relief of toothache due to Dental K02-TO-RE-TE-THM EMA required a dental cavityAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 31 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context320 Relieves the symptoms of Warning S DENT2 temporomandibular joint disorder required Oral K07-SY-RE-00-S00 diagnosed by a dentist or medical practitioner. 321 Assists in the management of Warning S DENT5 temporomandibular joint disorder required Oral K07-00-MG-AS-S00 diagnosed by a dentist or medical practitioner. 322 Assists in the management of mouth Warning S Oromucosal K12-00-MG-AS-S00 DENT6 (aphthous) ulcers required323Traditionally used in herbal medicine to help relieve mild irritations of the Warning S Buccal K12-IR-RE-HE-THM HC mucous membranes of the mouth or required throat324 Traditional herbal medicinal product used as a mouthwash and gargles for Warning S Oromucosal K12-MI-RE-00-THM EMA relief of minor inflammation of mucous required membranes of the oral cavity325Used in herbal medicine to help relieve minor inflammations of mucous Warning S Buccal K12-MI-RE-HE-NHM HC membranes of the mouth (aphthous required stomatitis/canker sore) (demulcent)326 Traditionally used in herbal medicine as an astringent to help relieve mild Warning S Buccal K12-MI-RE-HE-THM HC inflammations of the mucous required membranes of the mouth327 Traditional herbal medicinal product for Warning S management of minor ulcers and Topical K12-MI-MG-00-THM EMA required inflammation in the mouth328 Traditional herbal medicinal product for Warning S Oromucosal K12-MI-RE-SY-THM EMA the relief of symptoms of minor required /Topical inflammations of the oral mucosa Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context329 Relieves the symptoms of aphthous Warning S Buccal K12-SY-RE-00-S00 DENT3 ulcers. required330 Assists in the management of angular Warning S stomatitis/chelitis (cracks in the corners Topical K13-00-MG-AS-S00 SKIN20 required of the mouth)331 Warning S Relief of mouth ulcders Topical K13-UL-RE-00-S00 ULC1 required332 Relieves the symptoms of gastro- Warning S Oral K21-SY-RE-00-S00 DIG9 oesophageal reflux (heartburn) required333Traditionally used in herbal medicine to Warning S Oral K30-00-RE-HE-THM HC help relieve dyspepsia required334 Warning S Assists in the management of non- Oral K30-DY-MG-AS-S00 GAST8 required specific dyspepsia. 335 Warning S Relieves dyspepsia/indigestion Oral K30-DY-RE-00-S00 GAST3 required336 Traditionally used in Herbal Medicien to Warning S help relieve flatulent dyspepsia Oral K30-FL-RE-HE-THM HC required (carminative)337 Warning S Assists in the management of indigestion Oral K30-IN-MG-AS-S00 DIG10 required338 Warning S Relief of indigestion Oral K30-IN-RE-00-S00 INDIG1/3 required339 Traditional herbal medicinal product for the management of symptoms of mild Warning S Oral K30-MI-RE-SY-THM EMA dyspeptic complaints such as heartburn required and bloatingAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 33 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context340 Traditional herbal medicinal product Warning S used in mild dyspeptic/gastrointestinal Oral K30-MI-US-00-THM EMA required disorders341Traditionally used in herbal medicine to Warning S Oral K30-NE-RE-HE-THM HC help relieve nervous dyspepsia required342 Warning S Relieves the symptoms of indigestion Oral K30-SY-RE-00-S00 DIG5 required343 Traditional herbal medicinal product used to increase bile flow for the relief of Warning S symptoms of indigestion (such as Oral K30-SY-RE-00-THM EMA required sensation of fullness, flatulence, and slow digestion)344 Assists in the management of medically Warning S2 GAST10 diagnosed irritable bowel syndrome required Oral K58-00-MG-AS-S00345 Relieves the symptoms of medically Warning S2 GAST5 diagnosed irritable bowel syndrome required Oral K58-SY-RE-00-S00346 Warnings S and LAX1 required / Assists in the management of LAX2 & LAX 3 Oral K59-00-MG-AS-S00 GAST12 constipation required in certain circumstances347 Warnings S and LAX1 required / LAX2 & LAX 3 Assists in the prevention of constipation. Oral K59-00-PV-AI-S00 LAX1/3 required in certain circumstances348 Warnings S and LAX1 required / LAX2 & LAX 3 Assists in the relief of constipation. Oral K59-00-RE-AS-S00 CONST1 required in certain circumstances Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context349 Warnings S and LAX1 required / Used in herbal medicine to provide LAX2 & LAX 3 gentle relief of constipation and/or Oral K59-00-RE-GE-NHM HC required in irregularity certain circumstances350 Warnings S and LAX1 required / Herbal medicinal product for the LAX2 & LAX 3 Oral K59-HA-MG-00-NHM EMA management of habitual constipation required in certain circumstances351 Warnings S and LAX1 required / Gentle relief of occasional constipation LAX2 & LAX 3 Oral K59-OC-RE-GE-S00 HC (irregularity) required in certain circumstances352 Warnings S and LAX1 required / Used in herbal medicine for the short- LAX2 & LAX 3 Oral K59-OC-RE-ST-NHM HC term relief of occasional constipation required in certain circumstances353 Warnings S and LAX1 required / Traditionally used in herbal medicine for LAX2 & LAX 3 short-term use in cases of occasional Oral K59-OC-US-ST-THM EMA required in constipation certain circumstances354 Warnings S and LAX1 required / LAX2 & LAX 3 Relieves the symptoms of constipation Oral K59-SY-RE-00-S00 GAST7 required in certain circumstances355 Relieves the symptoms of mild digestive Warning S GAST1 disorders. required Oral K92-SY-RE-00-S00356 Relief of the pain of mild digestive Warning S GAST1 disorders. required Oral K92-PA-RE-00-S00357 Relief of the discomfort of mild digestive Warning S GAST1 disorders. required Oral K92-DI-RE-00-S00358 Traditionally used in herbal medicine to Oral KAP-00-ST-00-THM HC Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 35 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context stimulate the appetite (orexigenic)359Traditionally used in herbal medicine to Oral KAP-00-ST-HE-THM HC help stimulate appetite360Traditionally used in herbal medicine as an aromatic bitter to increase appetite Oral KAP-AB-IN-BI-THM HC (stomachic)361 Traditionally used in herbal medicine as Oral KAP-BI-IN-BI-THM HC a bitter to increase appetite362Used in herbal medicine to increase bile Oral KBI-EX-IN-00-NHM HC excretion by the liver (choleretic)363 Used in herbal medicine to help increase Oral KBI-FL-IN-HE-NHM HC bile flow (cholagogue)364 Traditionally used in herbal medicine to Oral KBI-FL-IN-HE-THM HC help increase bile flow (cholagogue)365 Traditionally used in herbal medicine to Oral KBI-SE-ST-00-THM HC stimulate secretion of bile (choleretic)366 Used in herbal medicine to promote LAX1, LAX2 & bowel movements by increasing bulk Oral KBO-MO-PR-BW-NHM HC LAX3 volume and water content367 Used in herbal medicine to promote LAX1, LAX2 & bowel movement (by direct action on Oral KBO-MO-PR-DA-NHM HC LAX3 the large intestine) Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context368 To promote bowel movement (by direct LAX1, LAX2 & Oral KBO-MO-PR-DA-S00 HC action on the large intestine) LAX3369 Traditionally used in herbal medicine to Warning S manage digestive disturbances Oral KDD-00-MG-00-THM HC required (dyspepsia)370 Traditionally used in herbal medicine to Warning S help relieve digestive disturbances Oral KDD-BF-RE-HE-THM HC required including bloating and flatulence371 Traditional herbal medicinal product for Warning S symptomatic relief of digestive disorders Oral KDD-DF-RE-SY-THM EMA required such as dyspepsia and flatulence372 Traditional herbal medicinal product for the releif of symptoms of digestive Warning S disorders such as dyspepsia with a Oral KDD-DY-RE-00-THM EMA required sensation of fullness, bloating and flatulence373Used in herbal medicine to help relieve Warning S digestive disturbances, such as Oral KDD-DY-RE-HE-NHM HC required dyspepsia374 Traditionally used in herbal medicine to Warning S help relieve digestive disturbances, such Oral KDD-DY-RE-HE-THM HC required as dyspepsia375 Traditionally used in herbal medicine to Warning S Oral KDD-FD-RE-HE-THM HC help relieve digestive disturbances such required as flatulent dyspepsia (carminative)Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 37 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context376Traditionally used in herbal medicine to help relieve digestive upset/disturbances including lack of Warning S Oral KDD-LA-RE-HE-THM HC appetite, nausea, digestive spasms, required indigestion, dyspepsia, and flatulent colic (carminative)377 Traditionally used in herbal medicine to help relieve mild digestive disturbances Warning S Oral KDD-MI-RE-HE-THM HC such as dyspepsia, flatulence, bloating, required and belching378 Used for the management of mild Warning S Oral KDD-MI-MG-00-S00 DIG9 digestive disorders, required379Traditional herbal medicinal product for the management of symptoms of mild, Warning S Oral KDD-MI-MG-SY-THM EMA spasmodic gastrointestinal complaints required including bloating and flatulence380Traditional herbal medicinal product for the relief of symptoms related to mild Warning S digestive disorders (such as feeling of Oral KDD-SY-RE-00-THM EMA required abdominal fullness, flatulence and slow digestion)381 Used in herbal medicine to aid digestion Oral KDI-00-AI-00-NHM HC Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context382 Aids digestive function/digestion Oral KDI-00-AI-00-S00 DIG1383 Traditionally used in herbal medicine to Oral KDI-00-AI-00-THM HC aid digestion (stomachic)384Traditionally used in herbal medicine as Oral KDI-00-AI-BI-THM HC a bitter to aid digestion385 Traditionally used in herbal medicine to Oral KDI-00-ST-00-THM HC stimulate digestion386Oral KDI-FA-DA-AS-S00 DIG7/8Used to assist in the distribution and assimilation of fats in the digestive system.387 Helps maintain healthy digestive Oral KDI-HE-MA-HE-S00 DIG2 function388 Digestive enzyme to assist in the digestion of foods containing lactose Oral KDI-LA-AS-00-S00 HC (e.g. dairy foods, milk). 389 Aids digestion. Oral KDI-LT-AI-00-S00 DIG3390 Helps maintain healthy digestive Oral KDI-LT-MA-HE-S00 DIG4 function.391 Warning S For the management of indigestion. Oral KDI-LT-MG-00-S00 INDIG4 required Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 39 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context392Traditionally used in herbal medicine to Warning S aid digestion in cases of nervousness Oral KDI-NS-AI-00-THM HC required and/or stress393 Traditionally used in herbal medicine as Oral KDI-TO-AI-00-THM HC a digestive tonic to aid digestion 394 Traditionally used as a digestive Oral KDS-AR-US-00-T00 HC stimulant (an aromatic)395Used in herbal medicine to stimulate contraction of the gallbladder Oral KGA-CT-ST-00-NHM HC (cholagogue)396 Warning S Relieves gastrointestinal discomfort Oral KGC-00-RE-00-S00 BM12 required397 Traditional herbal medicinal product for use as a demulcent preparation for the Warning S Oral KGC-00-RE-SY-THM EMA relief of symptoms of mild required gastrointestinal discomfort398Traditional herbal medicinal product for the relief of symptoms of mild, Warning S Oral KGC-MI-RE-SY-THM EMA spasmodic gastrointestinal complaints required including bloating and flatulence399Provides live microorganisms that Oral KGF-HE-CO-LM-S00 HC contribute to a natural healthy gut flora Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context400 Probiotic that contributes to a natural Oral KGF-HE-CO-PB-S00 HC healthy gut flora 401 Probiotic that forms part of a natural Oral KGF-HE-FO-PB-S00 HC healthy gut flora 402 Helps in the maintenance of healthy Oral KGU-00-DM-HE-S00 HC gums403 Helps in the development of healthy Oral KGU-00-DE-HE-S00 HC gums404 Warning S Assists in the management of sore gums Buccal KGU-SO-MG-AS-S00 DENT4 required405 Warning S Relief of the discomfort of sore gums Buccal KGU-SO-RE-00-S00 DENT1 required406 Helps support digestive system health Oral KHE-PS-SU-HE-S00 HC after periods of physical stress407 Warning S, Used as a laxative LAX1 & LAX2 & Oral KLA-00-US-00-S00 LAX2 LAX3 required408 Warnings LAX1 required / LAX2 Used in herbal medicine as a bulk- & LAX 3 Oral KLA-BF-US-00-NHM HC forming laxative required in certain circumstances409 Warnings LAX1 required / LAX2 Used in herbal medicine as a mild & LAX 3 Oral KLA-MI-US-00-NHM HC laxative required in certain circumstances410 Warnings LAX1 required / LAX2 Traditionally used in herbal medicine as & LAX 3 Oral KLA-MI-US-00-THM HC a mild laxative required in certain circumstances411 Traditionally used in herbal medicine as Warnings LAX1 Oral KLA-ST-US-00-THM HC a stimulant laxative required / LAX2 Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 41 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context& LAX 3 required in certain circumstances412 Used in herbal medicine to help support Oral KLI-FU-SU-HE-NHM HC liver function413 Helps to support liver function in Oral KLI-FU-SU-HE-S00 Liver 2/3, HC healthy people414 Traditionally used in herbal medicine as Oral KLP-00-US-00-THM HC a hepatoprotectant/liver protectant415 Maintenance of healthy mucous Oral KMM-HE-MA-AS-S00 BM02 membranes416 Helps to support mucous membrane Oral KMM-HE-SU-HE-S00 HC health 417 Warnings LAX1 required / LAX2 & LAX 3 Helps maintain regularity (bowel) Oral KRE-00-MA-HE-S00 LAX5 required in certain circumstances418Traditionally used in herbal medicine to Warning S help relieve digestive spasms (anti- Oral KSP-00-RE-HE-THM HC required spasmodic) 419 Warning S2 required Herbal medicinal product for the relief of symptoms of minor spasms of the gastrointestinal tract, flatulence and Oral KSP-MI-RE-SY-SHM EMA abodominal pain, especially in patients with medically diagnosed irritable bowel syndrome420 Helps in the development and Oral KTE-00-DM-HE-S00 HC maintenance of teeth Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context421 Traditionally used in herbal medicine as a digestive tonic and bitter to help Oral KTO-BI-US-00-THM HC stimulate appetite and aid digestion (stomachic)422 Liver tonic. Oral KTO-LT-US-00-S00 LIVER1423 Traditionally used in herbal medicine as a digestive tonic/digestive aid Oral KTO-ST-US-00-THM HC (stimulant)424 Traditionally used in Traditional Chinese Warning S Medicine (TCM) to support the healing Topical L02-00-HE-PR-TCM HC required of carbuncles425 Warning S Assists in the management of boils Topical L02-00-MG-AS-S00 BOIL2 required426 Traditional herbal medicinal product for Warning S the management of minor wounds and Topical L02-MI-MG-00-THM EMA required small boils (furuncles)427 Warning S Relieves the symptoms of boils Topical L02-SY-RE-00-S00 BOIL1 required428 Warning S2 Assists in the management of medically required Topical L20-00-MG-AS-S00 SKIN11 diagnosed dermatitis 429 Relieves the symptoms of medically Warning S2 Topical L20-00-RE-SY-S00 SKIN3 diagnosed dermatitis required430 For the management of medically Warning S2 SKIN19 diagnosed eczema or dermatitis. required Oral or L20-00-MG-00-S00 topical431 Traditional herbal medicinal product Warning S used in management of seborrhoeic skin Topical L21-00-MG-00-THM EMA required conditionsAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 43 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context432 Traditional herbal medicinal product Warning S Topical L21-00-US-00-THM EMA used in seborrheoic skin conditions required433Reduces the recurrence of symptoms Warning S Topical L21-SY-RD-00-S00 HC associated with dandruff required434Relieves symptoms associated with Warning S Topical L21-SY-RE-00-S00 HC dandruff required435 Warning S Assists in the management of itchy ears Topical L29-EA-MG-AS-S00 EAR5 required436 Warning S Relieves itchy ears Topical L29-EA-RE-00-S00 EAR2 required437 Relieves the symptoms of medically Warning S2 Oral or ECZ L30-SY-RE-00-S00 diagnosed eczema. required topical438 Relieves the skin symptoms of medically Warning S2 PSOR1 Topical L40-SY-RE-00-SSK diagnosed psoriasis required439 For the management of the skin Warning S2 PSOR2 symptoms of medically diagnosed required Topical L40-SY-MG-00-SSK psoriasis440 Assists in the management of medically Warning S2 SKIN10 diagnosed psoriasis. required Oral L40-00-MG-AS-S00441 Warning S Assists in the management of urticaria Topical L50-00-MG-AS-S00 SKIN16 required442 Warning S Relieves the symptoms of urticaria Topical L50-SY-RE-00-S00 SKIN8 required443 Assists in the management of minor Warning S Topical L55-MI-MG-AS-S00 SKIN14 [burns / sunburn] required Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context444 Relieves the symptoms of minor burns Warning S Topical L55-SY-RE-00-S00 SKIN6 (including sunburn). required445 Assist in the management of alopecia. Warning S HAIR Oral or required L63-00-MG-AS-S00 topical446 Warning S Assists in the management of acne Topical L70-00-MG-AS-S00 SKIN17 required447 Helps prevent new acne pimples from Warning S Topical L70-00-PV-HE-S00 HC forming required448 Assists in the management of Warning S Topical L70-MI-MG-AS-S00 SKIN13 mild/moderate acne required449 Warning S Relief of mild to moderate acne Topical L70-MI-RE-00-S00 SKIN5 required450 Assists in the prevention of bed sores. ULC2 (or) Assists in the prevention of decubitus ulcers. L89-00-PV-AS-S00451 Traditionally used in herbal medicine to Warning S relieve symptoms of chronic cutaneous Oral LCD-SC-RE-00-THM HC required diseases452 Traditional herbal medicinal product for Warning S symptomatic management of cutaneous Oral LCF-SY-MG-00-THM EMA required capillary fragility453 Helps in collagen formation to support Oral LCO-00-FO-HE-S00 HC skin and connective tissue health454 Warning S Manages dandruff LDA-00-MG-00-S00 DAN1 required455 Warning S Relieves dry skin Topical LDS-00-RE-SY-S00 SKIN4 required456 Warning S Assists in the management of dry skin Topical LDS-MA-AS-00-S00 SKIN12 required457 Traditional herbal medicinal product for Warning S Topical LID-MI-RE-00-THM EMA Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 45 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context relief of minor skin inflammation and required dryness of the skin458Traditionally used in herbal medicine to Warning S help relieve minor skin inflammations Topical LII-00-RE-HE-THM HC required and irritations459 Traditionally used in herbal medicine to Warning S help heal minor skin wounds, burns, Topical LII-MI-HE-HE-THM HC required irritations and local inflammations460 Used in herbal medicine to help relieve Warning S minor inflammation and/or irritation of Topical LII-MI-RE-HE-NHM HC required the skin461 Traditional herbal medicinal product for Warning S Topical LIN-MI-RE-00-THM EMA relief of minor skin inflammations required462 Traditional herbal medicinal product for Warning S the symptomatic management of minor Topical LIN-MI-MG-SY-THM EMA required inflammations of the skin463 Warning S Helps maintain healthy nails Oral LNA-HE-MA-HE-S00 BM21 required464 Relieves the symptoms of localised Warning S Topical LPR-LO-RE-SY-S00 EMA pruritic conditions in intact skin required465LSA-PR-PR-AI-S00 Aids in the prevention of premature skin ageing Topical SUNSC5466 Assists in management of dry or Warning S Topical LSK-DI-MG-00-S00 SKIN18 Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context inflamed skin conditions. required467 Helps to maintain healthy skin Oral LSK-HE-MA-HE-S00 HC468 Supports skin health Oral LSK-HE-SU-00-S00 SAN15/FNFC469 LSK-00-SS-BS-S00 Broad Spectrum Sunscreen Topical BROADS470 Sunscreen SPF4 Topical LSK-04-SS-00-S00 SPF04471 Sunscreen SPF6 Topical LSK-06-SS-00-S00 SPF06472 Sunscreen SPF8 Topical LSK-08-SS-00-S00 SPF08473 Sunscreen SPF10 Topical LSK-10-SS-00-S00 SPF10474 Sunscreen SPF12 Topical LSK-12-SS-00-S00 SPF12475 Sunscreen SPF15 Topical LSK-15-SS-00-S00 SPF15476 Sunscreen SPF16 Topical LSK-16-SS-00-S00 SPF16477 Sunscreen SPF17 Topical LSK-17-SS-00-S00 SPF17478 Sunscreen SPF18 Topical LSK-18-SS-00-S00 SPF18479 Sunscreen SPF19 Topical LSK-19-SS-00-S00 SPF19480 Sunscreen SPF20 Topical LSK-20-SS-00-S00 SPF20481 Sunscreen SPF21 Topical LSK-21-SS-00-S00 SPF21482 Sunscreen SPF22 Topical LSK-22-SS-00-S00 SPF22483 Sunscreen SPF23 Topical LSK-23-SS-00-S00 SPF23484 Sunscreen SPF24 Topical LSK-24-SS-00-S00 SPF24485 Sunscreen SPF25 Topical LSK-25-SS-00-S00 SPF25486 Sunscreen SPF26 Topical LSK-26-SS-00-S00 SPF26487 Sunscreen SPF27 Topical LSK-27-SS-00-S00 SPF27488 Sunscreen SPF28 Topical LSK-28-SS-00-S00 SPF28489 Sunscreen SPF29 Topical LSK-29-SS-00-S00 SPF29490 Sunscreen SPF30 Topical LSK-30-SS-00-S00 SPF30Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 47 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context491 Sunscreen SPF40 Topical LSK-40-SS-00-S00 SPF30492 Sunscreen SPF50 Topical LSK-50-SS-00-S00 SPF30493 Sunscreen SPF50 Plus Topical LSK-S+-SS-00-S00 SPF30494LSK-30+-S1-BS-S00 A broad spectrum sunscreening preparation of SPF30+. Can aid in the prevention of sunspots. Topical SUNSC1/2/3/4495A broad spectrum sunscreening LSK-30+-S2-BS-S00 preparation of SPF30+. Assists in preventing some skin cancers. Topical SUNSC1/2/3/4496LSK-30+-S3-BS-S00 A broad spectrum sunscreening preparation of SPF30+. Helps reduce the risk of some skin cancers. Topical SUNSC1/2/3/4497A broad spectrum sunscreening LSK-30+-S4-BS-S00 preparation of SPF30+. Aids in the prevention of solar keratoses Topical SUNSC1/2/3/4498LSK-04-SS-BS-S00 A broad spectrum sunscreening preparation of SPF4 or greater. Topical SUNSC5499A broad spectrum sunscreening LSK-50+-S1-BS-S00 preparation of SPF50+. Can aid in the prevention of sunspots. Topical SUNSC9500LSK-50+-S2-BS-S00 A broad spectrum sunscreening preparation of SPF50+. Assists in preventing some skin cancers. Topical SUNSC6501A broad spectrum sunscreening LSK-50+-S3-BS-S00 preparation of SPF50+. Helps reduce the risk of some skin cancers. Topical SUNSC7502 A broad spectrum sunscreening Topical LSK-50+-S4-BS-S00 SUNSC8 preparation of SPF50+. Aids in the Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context prevention of solar keratoses 503A broad spectrum sunscreening LSK-30-S1-BS-S00 preparation of SPF30. Can aid in the prevention of sunspots. Topical SUNSC9504LSK-30-S2-BS-S00 A broad spectrum sunscreening preparation of SPF30. Assists in preventing some skin cancers. Topical SUNSC14505A broad spectrum sunscreening LSK-30-S3-BS-S00 preparation of SPF30. Helps reduce the risk of some skin cancers. Topical SUNSC15506LSK-30-S4-BS-S00 A broad spectrum sunscreening preparation of SPF30. Aids in the prevention of solar keratoses Topical SUNSC16507A broad spectrum sunscreening LSK-40-S1-BS-S00 preparation of SPF40. Can aid in the prevention of sunspots. Topical SUNSC9508LSK-40-S2-BS-S00 A broad spectrum sunscreening preparation of SPF40. May assist in preventing some skin cancers. Topical SUNSC18509A broad spectrum sunscreening LSK-40-S3-BS-S00 preparation of SPF40. Helps reduce the risk of some skin cancers. Topical SUNSC19510 A broad spectrum sunscreening Topical LSK-40-S4-BS-S00 SUNSC20 preparation of SPF40. Aids in the prevention of solar keratoses Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 49 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context511A broad spectrum sunscreening LSK-50-S1-BS-S00 preparation of SPF50. Can aid in the prevention of sunspots. Topical SUNSC9512LSK-50-S2-BS-S00 A broad spectrum sunscreening preparation of SPF50. Assists in preventing some skin cancers. Topical SUNSC10513A broad spectrum sunscreening LSK-50-S3-BS-S00 preparation of SPF50. Helps reduce the risk of some skin cancers. Topical SUNSC11514LSK-50-S4-BS-S00 A broad spectrum sunscreening preparation of SPF50. Aids in the prevention of solar keratoses Topical SUNSC12515Helps maintain skin and membranes Oral LSM-00-MA-HE-S00 HC516LSS-00-PR-AI-S00Aids in the prevention of sunspots. Topical SUNSC4517 Used in herbal medicine to aid in the Warning S healing of minor wounds and cuts Topical LWC-MI-HE-AI-NHM HC required (vulnerary)518Traditionally used in Ayurveda to assist in the healing of minor wounds such as Warning S Topical LWC-MI-HE-AS-TAY HC cuts and burns, and minor skin required irritations519 Traditionally used in herbal medicine to Warning S Topical LWC-MI-HE-AS-THM HC assist healing of minor wounds such as required cuts and burns, and minor skin irritations Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context520 Traditionally used in herbal medicine to Warning S aid in the healing of minor wounds and Topical LWH-MI-HE-AI-THM HC required cuts (vulnerary)521 Traditional herbal medicinal product for Warning S the management of small superficial Topical LWO-SM-MG-00-THM EMA required wounds522Traditionally used in herbal medicine as Warning S an antimicrobial to help manage minor Topical LWS-MI-TR-AM-THM HC required wounds and sores523Traditionally used in herbal medicine as Warning S an antiseptic to help manage minor Topical LWS-MI-TR-AT-THM HC required wounds and sores524 Temporary relief of pain associated with Warning S GOUT1 acute gout. required Oral M10-PA-RE-TE-S00525 Helps improve joint mobility associated Warning S Oral M13-JM-IM-HE-S00 ARTH4 with arthritis required526 Traditional herbal medicinal product for Warning S Oral M13-MI-RE-00-THM EMA relief of mild joint pain required527 Relieves symptoms of medically Warning S2 RHEUM1 Oral M15-SY-RE-00-S00 diagnosed osteoarthritis. required528 Assists in the management of medically Warning S2 RHEUM3 diagnosed osteoarthritis. required Oral M15-00-MG-AS-S00Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 51 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context529 Assists in the management of the pain of Warning S2 RHEUM5 medically diagnosed osteoarthritis. required Oral M15-PA-MG-AS-S00530 Helps reduce joint inflammation Warning S Oral M19-JI-RD-HE-S00 ARTH2 associated with arthritis. required531 Helps reduce joint swelling associated Warning S Oral M19-JS-RD-HE-S00 ARTH3 with arthritis. required532 Warning S Temporary relief of the pain of arthritis. Oral M19-PA-RE-TE-S00 ARTH1 required533 Temporary relief of the pain of medically Warning S2 OSAR diagnosed osteoarthritis. required Oral M19-PA-RE-TE-SOA534 Traditional herbal medicinal product for Warning S Oral M25-MI-RE-00-THM EMA the relief of mild joint pain required535Traditional herbal medicinal product Warning S [used]to assist in the relief of minor Topical M25-MI-RE-AS-THM EMA required muscular and joint pain536 Herbal medicinal product used for the Warning S short-term management of low back Oral M45-00-MG-ST-NHM EMA required pain537Assists in the management of lower back Warning S Oral M54-00-MG-AS-S00 SKEL2/MUSC13 pain required538 Warning S Relieves the symptoms of low back pain Oral M54-00-RE-00-S00 MUSC8/SKEL1 required539 Warning S Temporary relief of lower back pain Oral M54-00-RE-TE-S00 NERV8 required540 Assists in the management of the Warning S NERV19 symptoms of sciatica. required Oral M54-SY-MG-AS-S00 Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context541 Temporary relief of the painful Warning S NERV7 symptoms of sciatica. required Oral M54-PS-RE-TE-S00542 Relief of the pain of medically diagnosed Warning S2 SCIAT Oral M54-PA-RE-00-S00 sciatica. required543 Assists in the management of medically Warning S2 MUSC12 diagnosed tenosynovitis. required Oral M70-00-MG-AS-S00544 Relieves the symptoms of medically Warning S2 MUSC7 Oral M70-SY-RE-00-S00 diagnosed tenosynovitis. required545 Warning S Relieves muscular aches and pains Oral/Topical M79-AP-RE-00-S00 MUSC1 required546 Used in herbal medicine as supportive Warning S therapy to help relieve rheumatic Oral M79-CO-RE-HE-NHM HC required complaints547 Traditionally used in herbal medicine to Warning S help relieve mild joint pain and Oral M79-JP-RE-HE-THM HC required inflammation548 Relieves the symptoms of localised Warning S Topical M79-LO-RE-SY-S00 EMA muscle pain required549Traditionally used in herbal medicine (as Warning S a rubefacient/counterirritant) to help Topical M79-MP-RE-HE-THM HC required relieve muscle pain550 Traditionally used in herbal medicine to Warning S help alleviate the pain associated with Oral M79-PA-AL-HE-THM HC required rheumatism551 Traditionally used in herbal medicine to Warning S Topical M79-PI-RE-HE-THM HC help temporarily relieve pain and/or required inflammation in muscles and joints (e.g. Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 53 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context sprains, bruises, mild joint pain)552Traditionally used in herbal medicine (as Warning S a rubefacient/counterirritant) to help Topical M79-SY-RE-HE-THM HC required relieve the symptoms of rheumatism553 Relief of the pain of fibrositis. Warning S Oral or FIBR M79-PA-RE-00-S00 required topical554 Relieves the symptoms of medically Warning S2 MUSC4 Oral M79-SY-RE-00-S00 diagnosed fibromyalgia. required555 Assists in the management of medically Warning S2 MUSC9 diagnosed fibromyalgia. required Oral M79-00-MG-AS-S00556 Relieves mild nerve pain/mild neuralgia. Warning S NERV9 Oral M79-NE-RE-00-S00 required538 Temporary relief of the pain of Warning S RHEUM rheumatism required Oral M79-PA-RE-TE-S00557 Temporary relief of rheumatic pain. Warning S RHEUM required Oral M79-RP-RE-TE-S00558 Assists in the management of medically Warning S2 OSPOR1 diagnosed osteoporosis. required Oral M85-00-MG-AS-S00559 Assists in the prevention of osteoporosis. Warning S OSPOR1 required Oral M85-CO-PV-AS-S00560 Assists in the management of medically Warning S2 Oral M85-00-MG-AS-SPW OSPOR2 diagnosed osteoporosis in post required menopausal women. Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context561 Assists in the prevention of osteoporosis Warning S OSPOR2 in post menopausal women. requiredOral M85-00-PV-AS-SPW562Helps in the development and Oral MBO-00-DM-HE-S00 HC maintenance of bones563 Helps bone formation Oral MBO-00-FO-HE-S00 FNFC564 Helps in the maintenance of bones. Oral MBO-00-MA-HE-S00 HC565 Adequate dietary calcium in our youth and throughout life is required to Oral MBO-00-MX-00-S00 CALC3 maximise bone.566Helps to attenuate/reduce bone mineral density (BMD) loss in post-menopausal women when used in conjunction with Oral MBO-DL-AR-HE-SPM HC adequate amounts of calcium and vitamin D567 Helps in the development and Oral MBO-GR-AI-00-S00 FNFC maintenance of bones and teeth (optional: "especially in childhood, Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 55 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context adolescence and young adulthood").568 Helps maintain healthy bones / bone Oral MBO-HE-MA-HE-S00 BM05 health569 Helps in the development of healthy Oral MCA-00-DM-HE-S00 HC cartilage570 Helps to protect against the Oral MCA-DE-PR-HE-S00 HC deterioration of cartilage571 Supports the growth of healthy joint Oral MCA-GR-SU-00-S00 SAN05 cartilage572 Helps to support cartilage integrity in Oral MCA-GR-SU-HE-S00 BM19 healthy individuals573 Helps in maintaining healthy cartilage Oral MCA-HE-MA-HE-S00 HC574 Supports healthy joint function Oral MFU-JO-SU-00-S00 SAN03575 Helps in maintaining joint health Oral MJO-HE-MA-00-S00 HC576 Used in herbal medicine to help relieve Warning S Oral MJO-IN-RE-HE-NHM HC mild joint inflammation required577 Relief of the pain and burning sensation Warning CYST CYST of cystitis. required Oral N30-PB-RE-00-S00578 Relieves the symptoms of medically Warning S2 MALE4 diagnosed benign prostatic hypertrophy. required Oral N40-SY-RE-00-S00579 Warning S Relieves the symptoms of vaginal itch. Topical N76-00-RE-00-S00 VAG3 required580 Assists in the management of heavy Warning S Oral N92-HE-MG-AS-S00 MENS11 periods required581 Warning S Relieves heavy periods Oral N92-HE-RE-00-S00 MENS7 required582 Assists in the management of irregular Warning S Oral N92-IR-MG-AS-S00 MENS12 Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context periods required583 Warning S Relieves irregular periods Oral N92-IR-RE-00-S00 MENS8 required584 Traditionally used in herbal medicine to Warning S help relieve the pain associated with Oral N94-00-RE-HE-THM HC required menstruation585 Warning S Relieves pre-menstrual breast pain Oral N94-BP-RE-00-S00 MENS4 required586 Warning S Relief of menstrual cramps. Oral N94-CR-RE-00-S00 MENS2 required587 Assists in the management of Warning S Oral N94-DM-MG-AS-S00 MENS10 dysmenorrhoea required588 Traditional herbal medicinal product for the reduction of heavy menstrual bleeding in women with regular Warning S Oral N94-HE-RE-00-THM EMA menstrual cycles, after serious required conditions have been excluded by a medical doctor589 Used in herbal medicine as a hormone Warning S normaliser to help stabilise menstrual Oral N94-IR-SB-HE-NHR HC required cycle irregularities590 Traditional herbal medicinal product for Warning S symptom management of minor spasm Oral N94-MI-MG-SY-THM EMA required associated with menstrual periods591 Traditional herbal medicinal product for the relief of minor symptoms in the days Warning S Oral N94-MS-RE-00-THM EMA before menstruation (premenstrual required syndrome)592 Used in Traditional Chinese Medicine Warning S Oral N94-PA-RE-00-TCM HC Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 57 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context(TCM) to relieve pain of menstruation required due to blood stasis593 Warning S Relieves menstrual pain/cramps Oral N94-PC-RE-00-S00 MENS1 required594 Assists in the management of pre- Warning S Oral N94-PM-MG-AS-S00 MENS9 menstrual tension/syndrome required595 Traditionally used in herbal medicine to Warning S help relieve the pain associated with Oral N94-PM-RE-HE-THM HC required menstruation 596 Relieves the symptoms of pre-menstrual Warning S Oral N94-PS-RE-00-S00 PMS/MENS5 syndrome required597Used in herbal medicine to help relieve Warning S Oral N94-PS-RE-HE-NHM HC premenstrual symptoms required598 Relieves the symptoms of Warning S Oral N94-SD-RE-00-S00 MENS6 dysmenorrhoea required599 Warning S Relieves menstrual symptoms Oral N94-SM-RE-00-S00 MENS3 required600 Relieves the symptoms of pre-menstrual Warning S Oral N94-SP-RE-00-S00 MENS5 tension required601 Relieves vaginal dryness and discomfort Warning S Oral N94-VD-RE-00-S00 VAG1 by local application required602 Assists in the management of Warning S Oral N95-00-MG-AS-S00 MENO4 menopause required603 Herbal medical product for the relief of Warning S menopausal complaints such as hot Oral N95-CO-RE-00-NHM EMA required flushes and profuse sweating604 Relieves hot flushes associated with Warning S Oral N95-HF-RE-00-S00 MENO2 menopause required Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context605 Reduces severity and frequent Warning S menopausal symptoms (such as hot Oral N95-SF-RE-00-S00 HC required flushes and/or night sweats)606 Warning S Relief of menopausal symptoms. Oral N95-SY-RE-00-S00 MENO1/3 required607 Used in herbal medicine to help relieve Warning S Oral N95-SY-RE-HE-NHM HC symptoms associated with menopause required608Traditional herbal medicinal product used as an adjuvant in minor urinary Warning CYST Oral NCO-MI-US-AD-THM EMA tract complaints609 Helps to support prostate health Oral NPR-HE-SU-HE-S00 HC610 Supports production of healthy sperm Oral NSP-HE-PD-SU-S00 BM04611Traditional herbal medicinal product Warning LAX1, used to increase the amount of urine to Oral NUT-FL-US-00-THM EMA LAX2 & LAX3? achieve flushing of the urinary tract612 Relieves [symptoms] of morning Warning S Oral O21-00-RE-00-S00 BM11 sickness (e.g., nausea / vomiting) required613 A daily dose of 400-500mcg of folic acid Warning NEUR Oral Q07-CO-PV-RR-S00 NEUR1 or folate, if taken daily for one month required, NS1 before conception and during the first trimester of pregnancy - reduces the risk of women having a child with birth defects of the brain such as anencephaly or spinal cord such as the neural tube defect known as spina bifida.Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 59 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context614 A daily dose of 400-500mcg of folic acid Warning NEUR NEUR2 or folate, if taken daily for one month required, NS1 before conception and during the first trimester of pregnancy - reduces the risk of having a child with spina bifida/neural tube defects. Oral Q07-CO-PV-RR-S00615 Warning S, Relief of coughs COU1 & COU2 Oral R05-00-RE-00-S00 COU2 required616 Warning S, Temporary relief of cough COU1 & COU2 Oral R05-00-RE-TE-S00 COU1 required617 Warning S, Traditionally used in herbal medicine to COU1 & COU2 Oral R05-SP-RE-HE-THM HC help relieve coughs (spasmolytic) required618 For temporary relief of cough. Warnings COU1 BRCH1 and COU2 Oral R05-CO-RE-TE-S00 required619 For the relief of cough. Warnings COU1 BRCH2 and COU2 Oral R05-CO-RE-00-S00 required620 Temporary relief of chest cough Warnings COU1 BRCH3 and COU2 Oral R05-CO-RE-TE-CH required621 Temporary relief of cough due to throat Warnings COU1 BRCH4 irritation and COU2 Oral R05-TI-RE-TE-S00 required622 Traditionally used in herbal medicine to Warning S help relieve intestinal colic Oral R10-00-RE-HE-THM HC required (antispasmodic)623 Used in herbal medicine to help relieve Warning S Oral R10-BS-RE-HE-NHM HC abdominal pain and burning sensation in required the stomach Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context624Traditionally used in herbal medicine to Warning S Oral R11-00-PV-HE-THM HC help prevent nausea (anti-emetic) required625 Traditionally used in herbal medicine to Warning S Oral R11-00-RE-HE-THM HC help relieve nausea and vomiting required626Helps prevent symptoms associated Warning S Oral R11-MO-PV-HE-S00 HC with motion sickness (nausea, vomiting) required627 Warning S Oral R12-00-MG-AS-S00 required Assists in the management of heartburn GAST9628 Warning S Oral R12-SY-RE-00-S00 Relieves symptoms of heartburn required GAST4629 Traditionally used in herbal medicine to Warning S Oral R14-00-EX-HE-T00 HC help expel intestinal gas (a carminative) required630 Traditionally used in herbal medicine to Warning S help relieve flatulence/to help expel Oral R14-00-RE-HE-THM HC required intestinal gas (carminative)631 Warning S Assists in the management of flatulence Oral R14-FL-MG-AS-S00 FLAT2/4 required632 Warning S Reduces flatulence Oral R14-FL-RD-00-S00 FLAT1 required633 Warning S Assists in the relief of flatulence Oral R14-LT-RE-AS-S00 FLAT3 required634 Assists in the management of halitosis Oral R19-HA-MG-AS-S00 DENT8Attachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 61 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context635Traditionally used in herbal medicine as Warning S an astringent to relieve symptoms of Oral R22-AS-RE-00-THM HC required localized inflamed swellings636 Assists in the prevention of muscular Warning S Oral R25-00-PV-AS-S00 MUSC3 cramps and spasms required637 Warning S Relieves muscular cramps and spasms Oral R25-00-RE-00-S00 MUSC2 required638Traditionally used herbal medicine to Warning S relieve nervousness Oral R45-00-AI-00-TWH HC required (calmative/sedative)639 Warning S Relieves irritability Oral R45-00-RE-00-S00 NERV10 required640 Warning S Improves stress adaptation. Oral R45-AD-IM-00-S00 NERV5 required641 Traditionally used in herbal medicine to Warning S Oral R45-CA-EA-HE-THM HC help ease nervous tension (calmative) required642 Traditionally used in herbal medicine to Warning S Oral R45-NE-RE-HE-THM HC help relieve nervousness (nervine) required643 Traditionally used in herbal medicine as Warning S a nervine to help relieve nervousness Oral R45-NR-RE-HE-THM HC required and restlessness644 Traditionally used in herbal medicine to Warning S help relieve nervousness (as mild Oral R45-SE-RE-HE-THM HC required sedative) Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context645 Traditional herbal medicinal product Warning S used to relieve symptoms of nervous Oral R45-SY-RE-00-THM EMA required tension646 Warning S Helps relieve nervous unrest. Oral R45-UN-RE-HE-S00 NERV11 required647 Helps relieve nervous tension Warning S NERV1 required Oral R45-00-RE-HE-S00648 Warning S Traditionally used to reduce fever Oral R50-00-RD-00-T00 HC required649Traditionally used in herbal medicine to Warning S Oral R50-00-RD-HE-THM HC help reduce fever (febrifuge) required650Traditionally used in herbal medicine to Warning S help relieve fever by inducing sweating Oral R50-00-RE-HE-THM HC required (diaphoretic)651 Traditional herbal medicinal product Warning S & used for the relief of fever associated Oral R50-CC-RE-00-THM EMA COLD required with common cold652 Traditional herbal medicinal product Warning S Oral R51-00-RE-00-THM EMA used for the relief of headache required653 Warning S Temporary relief of headache Oral R51-00-RE-TE-S00 HEAD1 required654 Traditionally used in Traditional Chinese Warning S Oral R52-00-RE-00-TCM HC Medicine (TCM) to relieve pain required655 Used in herbal medicine to reduce Warning S Oral R53-00-RD-00-NHM HC mental fatigue in cases of mental stress requiredAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 63 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context656 Helps temporarily to relieve fatigue, to promote endurance, and to enhance Oral R53-00-RE-HE-S00 HC motor performance 657 Temporarily supports alertness and Oral R53-00-SU-TE-S00 HC wakefulness658Traditionally used in Ayurveda to relieve general debility, especially during Oral R53-GE-RE-00-TAY HC convalescence or old age659 Helps relieve the daytime fatigue Oral R53-JL-RE-HE-S00 HC associated with jet lag660 Traditional herbal medicinal product for symptoms of asthenia such as fatigue Oral R53-SY-FO-00-THM EMA and weakness661 Traditional herbal medicinal product for symptoms of fatigue and sensation of Oral R53-SY-FR-00-THM EMA weakness662 Used in herbal medicine as a tonic to Oral R53-TO-AI-00-NHM HC help relieve general debility663 Assists in the management of fluid Warning FLRET FLRET1 retention. required Oral R60-00-MG-AS-S00664 Helps temporarily to promote alertness and wakefulness, and to enhance Oral RAW-00-PR-HE-S00 HC cognitive performance665 Helps to decrease cognitive fatigue due Oral RCF-PS-DE-HE-S00 HC to physically stressful situations (e.g. Extended wakefulness, exposure to cold, excessive noise) Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context666 Traditionally used in herbal medicine as Warning S, an expectorant to relieve coughs and COU1 & COU2 Oral REX-CC-US-00-T00 HC other affections of the chest required667 Warning S, Traditional herbal medicinal product COLD, COU1 & Oral REX-CC-US-00-THM EMA used as an expectorant in cough and cold COU2 required668 Traditional herbal medicinal product Warning S, used as an expectorant in cough COLD, COU1 & Oral REX-CO-US-00-THM EMA associated with cold COU2 required669 Traditionally used in herbal medicine as Warning S, an expectorant to help relieve cold COLD, COU1 & Oral REX-CS-US-00-THM HC symptoms such as excessive catarrh COU2 required670 Traditionally used in herbal medicine as an expectorant to help relieve excess Warning S Oral REX-MU-US-00-THM HC mucous of the respiratory passages required (anti-catarrhal)671 Warning S, Herbal medicinal product used as an COU1 & COU2 Oral REX-PC-US-00-THM EMA expectorant in case of productive cough required672 Traditionally used in herbal medicine as Warning S, an expectorant to help relieve coughs COLD, COU1 & Oral REX-RC-US-00-THM HC associated with cold COU2 required655 Used in herbal medicine to help improve Oral RPE-MP-IM-HE-NHM HC mental and/or physical performance after periods of mental and/or physical exertionAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 65 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context656 Traditionally used in herbal medicine to Warning S Topical RPR-SY-RE-HE-THM HC relieve symptoms of pruritus required657 Traditionally used in Traditional Chinese Warning S Topical RSW-00-RD-00-TCM HC Medicine (TCM) to reduce swelling required658 Warning S Assists in the management of sprains Topical T14-00-MG-AS-S00 MUSC10 required659 Traditional herbal medicinal product Warning S used for symptomatic management of Topical T14-IB-MG-SY-THM EMA required insect bites660 Traditional herbal medicine product for Warning S symptomatic management of bruises Topical T14-BR-MG-SY-THM EMA required and sprains661Traditionally used in herbal medicine as Warning S an astringent to relieve symptoms of Topical T14-AS-RE-SY-THM HC required bruises662 Assists in the management of minor skin Warning S wounds (e.g., cuts / scratches / Topical T14-MI-MG-AS-S00 SKIN15 required abrasions)663 Traditionally used in herbal medicine as an antimicrobial to help manage and Warning S Topical T14-MI-TR-AM-THM HC heal minor skin wounds, cuts, burns and required bruises664 Traditionally used in herbal medicine as Warning S Topical T14-MI-TR-AT-THM HC Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context an antiseptic to help manage and heal minor skin wounds, cuts, burns and required bruises665 Traditionally used to temporarily relieve Warning S the pain and reduce discoloration caused Topical T14-PD-RD-00-T00 HC required by bruises666 Traditional herbal medicinal product for Warning S relief of signs of bruises, such as local Oral T14-SI-RE-00-THM EMA required oedema and haematoma667 Warning S Relieves the symptoms of sprains Topical T14-SP-RE-00-S00 MUSC5 required668 Relieves symptoms of minor wounds Warning S Topical T14-SW-RE-SY-S00 SKIN7 (cuts - scratches - abrasions). required669 For the management of minor skin Warning S SKIN19 disorders such as wounds, scratches, required bruising, cuts and abrasions. Oral or T14-00-MG-00-S00 topical670 Traditionally used in herbal medicine to Warning S help relieve minor burns including Topical T20-MI-RE-HE-THM HC required sunburn 671 Warning S Relieves symptoms of chilblains Topical T69-SY-RE-00-S00 CHILB required672 Used in Traditional Chinese Medicine (TCM) to relieve symptoms of thirst due Warning S Oral T73-SY-RE-00-TCM HC to impairment of body fluids and required internal heat673 Assists in the management of motion Warning S Oral T75-00-MG-AS-S00 TRAV sickness requiredAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 67 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context674 Warning S Relieves symptoms of motion sickness Oral T75-MS-RE-00-S00 BM18 required675 Assists in the management of minor Warning S Oral T78-00-MG-AS-S00 ALLER3 allergy required676 Warning S Relieves the symptoms of allergies Oral T78-SY-RE-00-S00 ALLER/1 required677 Used in herbal medicine as a tonic to aid Oral Z54-TO-AI-00-NHM HC during convalescence678 Warning S Beneficial during times of stress. Oral Z73-00-BE-00-S00 NERV2/4 required679 Relieves symptoms of study or work- Warning S Oral Z73-00-RE-HE-NHM NERV6 related stress required680 Traditional herbal medicinal product for Warning S Oral Z73-SY-RE-00-THM EMA relief of mild symptoms of mental stress required681 Traditionally used in herbal medicine as Oral KTO-LT-US-00-THM FLAT4 a liver tonic682 Antioxidant Oral 0AO-00-US-00-S00 SAN08683 Traditionally used in herbal medicine as Topical 0AT-MI-US-00-THM HC a mild antiseptic684Helps strengthen bone and tissue in Oral 0BS-00-SN-00-SCO CALC2 growing and mature users. 685 Helps in the development and Oral 0BT-00-DM-HE-S00 HC maintenance of bones and teeth Therapeutic Goods Administration Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context686 Helps in the development and maintenance of bones and teeth Oral 0BT-00-DM-HE-SCA HC especially in childhood, adolescence and young adulthood687 Helps maintain cell health Oral 0CE-HE-MA-HE-S00 FNFC688 Helps in connective tissue formation Oral 0CT-00-FO-HE-S00 HC689 Helps to produce and repair connective Oral 0CT-00-PD-HE-S00 HC tissue690 Helps strengthen connective tissue Oral 0CT-00-SN-HE-S00 BM17691 Supports energy production Oral 0EY-00-PR-SU-S00 SAN10692 Helps to support a modest reduction in fat mass when used with a program of Oral 0FM-MR-SU-HE-S00 HC reduced intake of dietary calories and increased physical activity693 Supports foetal growth and development Oral 0FO-GD-SU-00-S00 SAN12694 Contributes to the normal growth of the Oral 0FO-GR-CO-00-S00 FNFC foetus695 Assists in the maintenance of normal healthy blood sugar/glucose balance in Oral 0GB-NH-MA-AS-S00 BLDGL03 healthy individuals.696 Assists in the maintenance of normal healthy glycaemic controls in healthy Oral 0GC-NH-MA-AS-S00 BLDGL02 individuals.697 Helps normal growth and development Oral 0GD-NO-HE-00-S00 HCAttachment 1: Expanded list of permitted indications Permitted (coded) indications for listed medicines - Consultation paper January 2013Page 69 of 70 Ref Proposed permitted indication Label Route of Target-QT-action- Source No disclaimers admin QA-context698 Assists in the maintenance of normal healthy blood sugar/glucose levels in Oral 0GL-NH-MA-AS-S00 BLDGL01 healthy individuals.

Attachment 1: Expanded List of Permitted Indications

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