Herbal substances - Therapeutic Goods Administration

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HERBAL SUBSTANCES 3.2.11 PROPOSED BOTANICAL NAME FOR A HERB USED IN THERAPEUTIC GOODS APPLICATION FORM See Appendix 3 3.2.12 PROPOSED NAME FOR A HERBAL SUBSTANCE USED IN THERAPEUTIC GOODS APPLICATION FORM See Appendix 4 3.2.13 PROPOSED BIOLOGICAL NAME FOR A HERBAL COMPONENT IN THERAPEUTIC GOODS APPLICATION FORM See Appendix 5 3.2.14 PROPOSED NAME FOR A PLANT FOOD USED IN THERAPEUTIC GOODS APPLICATION FORM See Appendix 6 207
HERBAL SUBSTANCES 3.3 HERBAL SUBSTANCES AAN LIST 3.3.1 Explanatory Notes The Herbal Substances AAN List (HSAL) contains Australian Approved Names (AANs) for Ingredients made from plant and plant-like material. 3.3.1.1 Ingredient Names Ingredient names, in full or in part, are given in column 1 of the following table. Where approved, current and complete, these names may be used in Australian Register of Therapeutic Goods (ARTG) applications and on labels where herbal ingredients are required to be named with an AAN. 3.3.1.2 Approved Herbal Names: Types and Components Herbal substances* are defined by indicating the herb species, the plant part and certain preparation details. The complete AAN for a herbal substance ingredient always specifies these details, but can do so in several ways. The information can be stated directly or the name can refer to a pharmacopoeial description or to a definition in the HSAL. The situation which applies is indicated in column 2. * the term "herbal substance" can have a more restricted meaning (refer to comments on the next page). In column 2, each ingredient name is identified as one of the following: AHN + part + prep MIS + part + prep INVALID AHS alone MIS + prep PHASED OUT AFN + food prep MIS alone PHASING OUT AFN alone Entry Under 3.3.1.3 Species-AHNs Where a valid and current ingredient name is the name of the herb species, it may be used as the first part of a complete AAN for a herbal substance. As indicated in column 2 by "AHN + part + prep", the plant part-AAN and preparation-AAN should be added to make the complete AAN. For more information, refer to Introduction to this section. 3.3.1.4 Substance-AHSs Where a valid and current ingredient name is linked to a pharmacopoeial monograph, "AHS alone" will be stated in column 2 and the name may be used as the complete AAN for the herbal substance. In column 3, the herb species, plant part, some preparation details and the monograph reference will be given. Abbreviations used to refer to pharmacopoeias are given in section 3.6 of the HSAL Introduction. Where there is a monograph for a herbal substance in the most recent editionof the British Pharmacopoeia (BP), the ingredient must comply with both the description and the standards set out in that BP monograph (refer section 3.3 of the HSAL Introduction). In this case, the ingredient must be named with the substance-AHS. On labels, the species-AHN format may be used in addition to naming the ingredient with the substance-AHS. 208
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
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HERBAL SUBSTANCES INGREDIENT NAME R
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COMMON NAMES SPECIES-AHN EXAMPLES A
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COMMON NAMES SPECIES-AHN EXAMPLES A
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COMMON NAMES SPECIES-AHN EXAMPLES B
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COMMON NAMES SPECIES-AHN EXAMPLES B
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COMMON NAMES SPECIES-AHN EXAMPLES C
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COMMON NAMES SPECIES-AHN EXAMPLES E
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COMMON NAMES SPECIES-AHN EXAMPLES F
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COMMON NAMES SPECIES-AHN EXAMPLES G
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COMMON NAMES SPECIES-AHN EXAMPLES H
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COMMON NAMES SPECIES-AHN EXAMPLES J
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COMMON NAMES SPECIES-AHN EXAMPLES L
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COMMON NAMES SPECIES-AHN EXAMPLES M
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COMMON NAMES SPECIES-AHN EXAMPLES N
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COMMON NAMES SPECIES-AHN EXAMPLES P
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COMMON NAMES SPECIES-AHN EXAMPLES R
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COMMON NAMES SPECIES-AHN EXAMPLES S
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COMMON NAMES SPECIES-AHN EXAMPLES U
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COMMON NAMES SPECIES-AHN EXAMPLES W
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HERBAL SUBSTANCES 3.5 HERBAL SUBSTA
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HERBAL SUBSTANCES 3.5.1.5 Additiona
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HERBAL SUBSTANCES Where flowers and
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3.5.2 Herbal Substances Plant Parts
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HERBAL SUBSTANCES PLANT PART AANs:
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HERBAL SUBSTANCES 3.6.1.2 Finding P
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HERBAL SUBSTANCES A “liquid extra
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HERBAL SUBSTANCES Variation in extr
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HERBAL SUBSTANCES Labels: Complete
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HERBAL SUBSTANCES 3.6.1.4 Using Pla
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HERBAL SUBSTANCES Character Meaning
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PLANT PREPARATIONS Essence, oil ...
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PLANT PREPARATIONS PREPAR- ATION TY
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PLANT PREPARATIONS oil infused ...
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HERBAL SUBSTANCES 3.7 HERBAL COMPON
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HERBAL SUBSTANCES HERBAL COMPONENT
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Therapeutic Goods Administration PO
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Herbal substances - Therapeutic Goods Administration

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