Herbal substances - Therapeutic Goods Administration

More documents

Recommendations

Info

HERBAL SUBSTANCES e. an additional herbal component name (refer Herbal Component AAN List Introduction) • may be used where it correctly represents a synonym of the HCN used eg. xanthophyll (lutein) • may be used where it is an approved “label-HCN” eg. “lignans” for “lignans calculated as secoisolariciresinol diglucoside (of Linum usitatissimum)” • may not be used where the component is quantified on the label or in the indications 201
HERBAL SUBSTANCES 3.2 PROPOSING A HERBAL AAN The expression of herbal ingredients in ARTG applications involves seven types of AANs: Type of AAN Example species-AHN Mentha x piperita plant part-AAN seed Preparation-AAN oil ess. MIS-AAN* Thymus vulgaris MIS Substance-AHS* Peppermint Oil food-AFN* wheat germ food preparation-AAN juice fresh active component HCN anthocyanosides active component AAN menthol * Where a proposed substance-AHS, food-AFN or MIS-AAN is not adopted, name the herbal ingredient with the species-AHN + plant part-AAN + plant preparation-AAN. Contact the Herb Names Co-ordinator BEFORE proposing any herbal AAN. AAN's must be approved BEFORE submitting an application to list or vary a product for supply in Australia. 3.2.1 Proposing a Species-AHN To propose a species-AHN, submit the completed application form: Proposed Botanical Name for a Herb used in Therapeutic Goods (see next section). The proposed botanical name should be given. Attach supporting material from botanical references. Where required, it is recommended that supporting material includes information drawn from a botanical flora of the area in which the plant is native eg Flora Europea. There is no set order of priority in the botanical references. Where the botanical references are not in agreement or the reliability of the information is in question, advice is sought by the TGA from the staff of herbaria in order to select the botanical name in accordance with the most recent edition of the International Code of Botanical Nomenclature. 3.2.2 Proposing a Plant Part-AAN Contact the Herb Names Co-ordinator to find out if there is an existing plant part-AAN that is appropriate. If necessary, a new plant part-AAN will be created. 3.2.3 Proposing a Plant Preparation-AAN Contact the Herb Names Co-ordinator to find out if there is an existing preparation-AAN that is appropriate. If necessary, a new preparation-AAN will be created. 3.2.4 Proposing a MIS-AAN A sponsor may propose an MIS-AAN by submitting to the Office of Complementary Medicines a detailed submission clearly establishing that the proposed interchangeable herbal material has very similar therapeutic action(s) and use(s) when used in the same strength. 202
Page 1 and 2: TGA Approved Terminology for Medici
Page 3 and 4: 3. HERBAL SUBSTANCES HERBAL SUBSTAN
Page 5 and 6: 3.1 INTRODUCTION HERBAL SUBSTANCES
Page 7 and 8: HERBAL SUBSTANCES Some preparation
Page 9 and 10: HERBAL SUBSTANCES 3.1.3.4 Using the
Page 11: HERBAL SUBSTANCES 3.1.5 Common Name
Page 15 and 16: HERBAL SUBSTANCES 3.2.6 Proposing a
Page 17 and 18: HERBAL SUBSTANCES 3.2.10 Proposing
Page 19 and 20: HERBAL SUBSTANCES 3.3 HERBAL SUBSTA
Page 21 and 22: HERBAL SUBSTANCES 3.3.1.9 Phased Ou
Page 23 and 24: HERBAL SUBSTANCES Registrable - poi
Page 25 and 26: HERBAL SUBSTANCES INGREDIENT NAME R
Page 63 and 64:
HERBAL SUBSTANCES INGREDIENT NAME R
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
COMMON NAMES SPECIES-AHN EXAMPLES A
Page 153 and 154:
COMMON NAMES SPECIES-AHN EXAMPLES A
Page 155 and 156:
COMMON NAMES SPECIES-AHN EXAMPLES B
Page 157 and 158:
COMMON NAMES SPECIES-AHN EXAMPLES B
Page 159 and 160:
COMMON NAMES SPECIES-AHN EXAMPLES C
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
COMMON NAMES SPECIES-AHN EXAMPLES E
Page 167 and 168:
COMMON NAMES SPECIES-AHN EXAMPLES F
Page 169 and 170:
COMMON NAMES SPECIES-AHN EXAMPLES G
Page 171 and 172:
COMMON NAMES SPECIES-AHN EXAMPLES H
Page 173 and 174:
COMMON NAMES SPECIES-AHN EXAMPLES J
Page 175 and 176:
COMMON NAMES SPECIES-AHN EXAMPLES L
Page 177 and 178:
COMMON NAMES SPECIES-AHN EXAMPLES M
Page 179 and 180:
COMMON NAMES SPECIES-AHN EXAMPLES N
Page 181 and 182:
COMMON NAMES SPECIES-AHN EXAMPLES P
Page 183 and 184:
COMMON NAMES SPECIES-AHN EXAMPLES R
Page 185 and 186:
COMMON NAMES SPECIES-AHN EXAMPLES S
Page 187 and 188:
Page 189 and 190:
Page 191 and 192:
COMMON NAMES SPECIES-AHN EXAMPLES U
Page 193 and 194:
COMMON NAMES SPECIES-AHN EXAMPLES W
Page 195 and 196:
HERBAL SUBSTANCES 3.5 HERBAL SUBSTA
Page 197 and 198:
HERBAL SUBSTANCES 3.5.1.5 Additiona
Page 199 and 200:
HERBAL SUBSTANCES Where flowers and
Page 201 and 202:
3.5.2 Herbal Substances Plant Parts
Page 203 and 204:
HERBAL SUBSTANCES PLANT PART AANs:
Page 205 and 206:
Page 207 and 208:
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
Page 217 and 218:
Page 219 and 220:
Page 221 and 222:
Page 223 and 224:
Page 225 and 226:
HERBAL SUBSTANCES 3.6.1.2 Finding P
Page 227 and 228:
HERBAL SUBSTANCES A “liquid extra
Page 229 and 230:
HERBAL SUBSTANCES Variation in extr
Page 231 and 232:
HERBAL SUBSTANCES Labels: Complete
Page 233 and 234:
HERBAL SUBSTANCES 3.6.1.4 Using Pla
Page 235 and 236:
HERBAL SUBSTANCES Character Meaning
Page 237 and 238:
PLANT PREPARATIONS Essence, oil ...
Page 239 and 240:
PLANT PREPARATIONS PREPAR- ATION TY
Page 241 and 242:
PLANT PREPARATIONS oil infused ...
Page 243 and 244:
HERBAL SUBSTANCES 3.7 HERBAL COMPON
Page 245 and 246:
HERBAL SUBSTANCES HERBAL COMPONENT
Page 247 and 248:
Page 249 and 250:
Page 251 and 252:
Page 253 and 254:
Page 255 and 256:
Page 257:
Therapeutic Goods Administration PO
show all

Herbal substances - Therapeutic Goods Administration

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?