Therapeutic Goods Amendment Regulations 2002 (No. 1) (Cth)

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Therapeutic Goods Amendment Regulations 2002 (No. 1)1

Statutory Rules 2002 No. 842

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

Parliamentary Secretary to the Minister for Health

and Ageing

1Name of Regulations

 These Regulations are the Therapeutic Goods Amendment Regulations 2002 (No. 1).

2Commencement

 These Regulations commence on gazettal.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(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 3Therapeutic goods attracting no fee under Division 1 or 2 of Part 3 of the Act

[5]Schedule 4, Part 1, heading

substitute

Part 1Listable 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 1Plant 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 2Plant 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

  • (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

  • (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

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