Therapeutic Goods Amendment Regulations 2002 (No. 1)1
I, PETER JOHN HOLLINGWORTH, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.
Dated 2 May 2002
PETER HOLLINGWORTH
Governor-General
By His Excellency’s Command
TRISH WORTH
1 Name of Regulations
These Regulations are the Therapeutic Goods Amendment Regulations 2002 (No. 1).
2 Commencement
These Regulations commence on gazettal.
3 Amendment of Therapeutic Goods Regulations 1990
Schedule 1 amends the Therapeutic Goods Regulations 1990.
Schedule 1 Amendments
(regulation 3)
[1] Subregulation 12 (1B)
omit
[2] Schedule 3, Part 1, paragraph 2B (a)
omit
2 or 3
insert
1A, 3, 4, 5, 7 or 8
[3] Schedule 3, Part 1, paragraph 3 (g)
omit
or animal
insert
, animal, bacterial or recombinant
[4] Schedule 3, Part 3, heading
substitute
Part 3 Therapeutic goods attracting no fee under Division 1 or 2 of Part 3 of the Act
[5] Schedule 4, Part 1, heading
substitute
Part 1 Listable goods
[6] Schedule 4, Part 1, paragraph 2 (b)
omit
6,
[7] Schedule 4, Part 1, paragraph 2 (c)
omit
or 3
insert
, 1A, 3, 4, 5, 7 or 8
[8] Schedule 4, Part 1, subparagraph 3 (d) (ii)
substitute
(ii) if it contains a herbal substance derived from plant material mentioned in an item in the table in Division 2 of that Part — is consistent with the qualification mentioned in column 2 of that item; and |
[9] Schedule 4, Part 1, subparagraph 3 (g) (ii)
substitute
(ii) with a label showing the warning (or words to the same effect) mentioned, in relation to the substance, in column 3 of the table in that Division; |
[10] Schedule 4, Part 2, column 1
omit
Ascorbyl palmitate in oral preparations, if the goods are labelled with a recommended daily dose that is equivalent to 100mg or less of ascorbyl palmitate
insert
Ascorbyl palmitate, other than ascorbyl palmitate in an oral preparation the recommended daily dose of which contains more than 100mg of ascorbyl palmitate
[11] Schedule 4, Part 3
after
Chromium (III) chloride
insert
Colloidal anhydrous silica, other than colloidal anhydrous silica in a preparation the proposed route of administration of which is by inhalation
[12] Schedule 4, Part 3
after
Potassium sulfate
insert
Silicon dioxide, other than silicon dioxide in a preparation the proposed route of administration of which is by inhalation
[13] Schedule 4, Part 4, Division 1, heading
substitute
Division 1 Plant material from which herbal substances in listable goods must not be derived
[14] Schedule 4, Part 4, Division 1
omit
Herbal substances derived from the following plant material
[15] Schedule 4, Part 4, Division 1, table, column 2
omit
[16] Schedule 4, Part 4, Division 2
substitute
Division 2 Plant material from which herbal substances may be derived for listable goods that are consistent with certain qualifications
Item | Plant material | Qualification |
1 | Abrus cantoniensis | if the herbal substance is derived from the seed — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry seed |
2 | Arisaema (all or any species) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
3 | Armoracia rusticana (Cochlearia armoracia) | the preparation does not contain, for its recommended daily dose, more than 20mg of volatile oil components |
4 | Arnica (all or any species) | if the preparation is for any use other than external use — it does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
5 | Arum maculatum | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
6 | Backhousia citriodora | (a) the herbal substance is derived from leaf oil only; and (b) the proposed route of administration of the preparation is topical only; and (c) the concentration of the herbal substance does not exceed 10mg per g of the preparation; and |
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| (d) the label on the goods includes the following warnings (or words to the same effect): If skin irritation occurs, discontinue use Not recommended for use by children aged 12 years or under Not recommended for use by pregnant or lactating women |
7 | Brachyglottis (all or any species) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
8 | Brassica (all or any species) | if the herbal substance is derived from the seed — the preparation does not contain, for its recommended daily dose, more than 20mg of allyl isothiocyanate (volatile oil component) |
9 | Brunfelsia uniflora | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
10 | Chenopodium ambrosioides | the preparation does not contain, for its recommended daily dose, more than 10mg of volatile oil components |
11 | Cicuta virosa | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
12 | Croton (all or any species) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
13 | Daphne mezereum | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
14 | Dryopteris filix-mas | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
15 | Echium vulgare | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
16 | Euonymus europaeus | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
17 | Helleborus (all or any species) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
18 | Hirschfeldia incana | if the herbal substance is derived from the seed — the preparation does not contain, for its recommended daily dose, more than 20mg of allyl isothiocyanate (volatile oil component) |
19 | Hydnocarpus anthelmintica | if the herbal substance is derived from the seed or seed oil and the preparation is for any use other than external use — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry seed |
20 | Hypericum perforatum | if the preparation is not a homoeopathic preparation and the proposed route of administration of the preparation is oral — the label on the goods includes the following warning: St John’s Wort affects the way some prescription medicines work. Consult your doctor. |
21 | Kunzea ambigua | (a) the herbal substance is derived from essential oils only; and (b) the proposed route of administration of the preparation is topical or by inhalation of the vapour only; and (c) the preparation is supplied in a container with a restrictive flow insert; and |
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| (d) the label on the goods includes the following warnings (or words to the same effect): For external use only Keep out of the reach of children Not to be applied undiluted to the skin except on the advice of a health care practitioner |
22 | Lantana camara | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
23 | Lathyrus sativus | if the preparation contains lathyrogenic amino acids — it does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
24 | Lithospermum (all or any species) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
25 | Lycopersicon esculentum | if the preparation is for any use other than external use — it does not contain, for its recommended daily dose, more than 10mg of total steroidal alkaloids |
26 | Medicago sativa | the L-canavanine level is not more than that of the dried leaf of the plant |
27 | Menispermum canadense | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
28 | Mentha pulegium | (a) if the preparation is for external use — it does not contain, for its recommended daily dose, more than 150mg of volatile oil components; and (b) if the preparation is for any other use — it does not contain, for its recommended daily dose, more than 50mg of volatile oil components |
29 | Monstera deliciosa | if the herbal substance is derived from the leaf — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry leaf |
30 | Morinda citrifolia | the herbal substance is fruit juice only |
31 | Oenanthe (all or any species) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
32 | Paullinia cupana | the label on the goods states: (a) that the goods contain caffeine; and (b) the quantity of caffeine per dosage unit |
33 | Peumus boldus | the preparation does not contain, for its recommended daily dose, more than 100mg of volatile oil components |
34 | Phytolacca decandra (americana) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
35 | Piper methysticum | (a) the preparation does not contain, for its recommended daily dose, more than 250mg of kavalactones; and (b) if the preparation is in a tablet or capsule — the amount of kavalactones does not exceed 125mg for each tablet or capsule; and (c) if the preparation is in a tea bag — the amount of dried rhizome does not exceed 3g for each tea bag; and |
|
| (d) if the preparation contains more than 25mg of kavalactones per dose — the label on the goods includes the following warnings (or words to the same effect): Not for prolonged use. If symptoms persist, seek advice from a health care practitioner Not recommended for use by pregnant or lactating women |
36 | Prunus dulcis (P. amygdalus) var. amara | if the herbal substance is derived from the seed — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry seed |
37 | Pseudolarix kaempferi | if the herbal substance is derived from plant parts other than the stem, bark or root, or if the preparation is for any use other than external use — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
38 | Pseudowintera colorata | the herbal substance is derived from the leaf only |
39 | Rhododendron molle | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
40 | Ricinus communis | the herbal substance is the fixed oil of the seed only |
41 | Robinia pseudoacacia | if the herbal substance is derived from plant parts other than the leaf or flower — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
42 | Rohdea japonica | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
43 | Santalum spicatum | (a) the herbal substance is oil derived from the root or stem wood only; and (b) the proposed route of administration of the preparation is topical or by inhalation only |
44 | Schoenocaulon officinale (Sabadilla officinarum, Veratrum officinale) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
45 | Semecarpus anacardium (Anacardium orientale) | if the herbal substance is derived from plant parts other than the seed — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
46 | Sinapsis alba | if the herbal substance is derived from the seed — the preparation does not contain, for its recommended daily dose, more than 20mg of allyl isothiocyanate (volatile oil component) |
47 | Solanum (all or any species) | if the preparation is for any use other than external use — it does not contain, for its recommended daily dose, more than 10mg of total steroidal alkaloids including solanine, solaneine and solanidine |
48 | Spigelia marilandica | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
49 | Tamus communis | if the herbal substance is derived from the fruit or root — the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
50 | Teucrium (all or any species) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
51 | Toxicodendron radicans (Rhus toxicodendron) | the preparation does not contain the herbal substance in a quantity that exceeds, for the recommended daily dose of the preparation, the equivalent of 1mg of the dry herbal material |
[17] Schedule 4, Part 5, Division 1
omit
Fish oils used as a source of omega-3 marine triglycerides — if accompanied by information that the recommended daily intake of omega-3 marine triglycerides is less than 1 g
Fish oils used as a source of vitamins
insert
Fish oils
[18] Schedule 4, Part 5, Division 1
omit
Sodium beta-hydroxy-beta-methylbutyra
insert
Sodium beta-hydroxy-beta-methylbutyrate
[19] Schedule 4, Part 5, Division 1
insert in appropriate alphabetical position
Acetyllevocarnitine hydrochloride
Black boned chicken powder
Bromelains
Conifer phytosterol complex
Demineralised fish proteoglycan extract
Glucosamine sulfate potassium chloride complex
Glucosamine sulfate sodium chloride complex
Levocarnitine
Levocarnitine fumarate
Levocarnitine hydrochloride
Levocarnitine magnesium citrate
Levocarnitine tartrate
Phosphatidylserine‑enriched soy lecithin
Propionyllevocarnitine hydrochloride
R‑alpha lipoic acid
R, S‑alpha lipoic acid
Streptococcus thermophilis
[20] Schedule 4, Part 5, Division 2, Subdivision 2, item 6
omit
[21] Schedule 4, Part 5, Division 3, item 1A, column 3
omit
Words to the following effect:
[22] Schedule 4, Part 5, Division 3, after item 1A
insert
1B | Bovine lactoferrin | Derived from cows milk |
[23] Schedule 4, Part 5, Division 3, item 5
omit
[24] Schedule 4, Part 5, Division 3, item 5A, column 3
omit
Words to the following effect:
[25] Schedule 4, Part 5, Division 3, item 6, column 2
omit
Sodium selenite,
insert
Sodium selenate, sodium selenite,
[26] Schedule 4, Part 5, Division 3, item 6A, column 3
omit
Words to the following effect:
[27] Schedule 5, subparagraph 7 (f) (iv)
omit
[28] Schedule 5A, item 6
omit
[29] Schedule 11, Part 2, paragraph 3 (a)
omit
gm
insert
g
Notes
1. These Regulations amend Statutory Rules 1990 No. 394, as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 No. 9.
2. Notified in the Commonwealth of Australia Gazette on 9 May 2002.