Therapeutic Goods Amendment Regulations 2004 (No. 1) (Cth)

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Therapeutic Goods Amendment Regulations 2004 (No. 1)1

Statutory Rules 2004 No. 782

I, PHILIP MICHAEL JEFFERY, 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 22 April 2004

P. M. JEFFERY

Governor-General

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

Contents

1Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2004 (No. 1).

2Commencement

These Regulations commence on the date of their notification in the Gazette.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

4Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 2 amends the Therapeutic Goods (Medical Devices) Regulations 2002.

Schedule 1Amendments of Therapeutic Goods Regulations 1990

(regulation 3)

[1]Paragraph 24 (1) (a)

omit the second mention of

or

[2]Subregulation 47 (3)

omit

subregulation 9AA (3) or 9S (3).

insert

subregulation 9 (3).

[3]Schedule 3, Part 1, paragraph 2B (a)

substitute

  1. (a)

    are not mentioned in item 1, 1A, 3, 4, 5, 7, 8, 9, 10, 11 or 12 in Schedule 5A; and

[4]Schedule 4, Part 1, paragraph 2 (c)

substitute

  1. (c)

    item 1, 1A, 3, 4, 5, 7, 8, 9, 10, 11 or 12 of Schedule 5A applies

[5]Schedule 4, Part 3

after

Ferrous sulfate

insert

High selenium yeast

[6]Schedule 4, Part 3

after

Potassium sulfate

insert

Selenocysteine

Selenomethionine

[7]Schedule 4, Part 3

after

Sodium phosphate

insert

Sodium selenate

Sodium selenite

Sodium sulfate

[8]Schedule 4, Part 4, Division 2, after item 49

insert

49A

Terminalia ferdinandiana

the preparation contains only aqueous extracts of the fruit flesh or fruit flesh dry

[9]Schedule 4, Part 5, Division 1

omit

Calcium sodium caseinate

[10]Schedule 4, Part 5, Division 1

after

Dolomite

insert

Emu oil

[11]Schedule 4, Part 5, Division 1

after

Levocarnitine tartrate

insert

Lutein

[12]Schedule 4, Part 5, Division 1

after

Tocotrienols complex — palm

insert

Zeaxanthin

[13]Schedule 4, Part 5, Division 3, items 1A to 1C

substitute

1A

Activated charcoal

Use with caution in children as may interfere with absorption of nutrients

May interact with other medicines

Not recommended for long term use

1B

Ademetionine in the form of sulphate salts, tosylate salts or mixed sulphate and tosylate salts

Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner

1C

Bovine colostrum powder

Derived from cows milk

Not suitable for infants under 12 months without medical advice

1D

Bovine lactoferrin

Derived from cows milk

1E

Calcium sodium caseinate

Derived from cows milk

[14]Schedule 4, Part 5, Division 3, after item 6

insert

6AA

Sodium sulfate, other than sodium sulfate intended for laxative use

May have a laxative effect

[15]Schedule 5A, after item 9

insert

10

Therapeutic goods imported into Australia by a medical practitioner or a member of a medical team (being 1 or more persons under the professional supervision of a medical practitioner)

  1. (a)

    the medical practitioner or medical team must be accompanying a person to Australia who:

    1. (i)

      has a critical illness; and

    2. (ii)

      is under the direct care and supervision of the practitioner or team; and

  2. (b)

    the goods must be for use in the treatment of the person who has the critical illness; and

  3. (c)

    the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and

  1. (d)

    the quantity of the goods must be consistent with the quantity required for the treatment of the person mentioned in paragraph (b); and

  1. (e)

    the goods must not be supplied to, or used in the treatment of, a person other than the person mentioned in paragraph (b); and

  1. (f)

    any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and

  1. (g)

    the medical practitioner, or a member of the medical team, must be responsible for the control and custody of the goods while the practitioner or team is in Australia; and

  2. (h)

    the person mentioned in paragraph (g) must:

    1. (i)

      carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

  1. (ii)

    for each of the goods that is not a therapeutic device — include in the list the generic name and strength of the active ingredient of the goods; and

  2. (iii)

    keep a record of the use of the goods while the medical practitioner or medical team is in Australia; and

  1. (iv)

    produce the list or record for inspection at the request of a customs officer or a person who is an authorised officer for the purposes of a provision of Part 5 of these Regulations.

11

Therapeutic goods imported into Australia by a member of a group of persons

  1. (a)

    the group must include a person who is the Head of State or Head of Government of a foreign country and senior Government officials of that country, who are visiting Australia on official business; and

  2. (b)

    the goods must be for use in the treatment of a member or members of the visiting group; and

  1. (c)

    the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and

  2. (d)

    the goods must not be supplied to, or used in the treatment of, a person other than a member of the visiting group; and

  3. (e)

    any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and

  4. (f)

    a member of the visiting group must be responsible for the control and custody of the goods while the group is in Australia; and

  5. (g)

    the person mentioned in paragraph (f) must:

    1. (i)

      carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

  1. (ii)

    for each of the goods that is not a therapeutic device — include in the list the generic name and strength of the active ingredient of the goods; and

  2. (iii)

    keep a record of the use of the goods while the group is in Australia; and

  3. (iv)

    produce the list or record for inspection at the request of a customs officer or a person who is an authorised officer for the purposes of a provision of Part 5 of these Regulations.

12

Therapeutic goods that are part of the medical supplies of a ship (including a yacht or other marine vessel) or aircraft visiting Australia

  1. (a)

    the goods must be for use in the treatment of a passenger or a member of the crew travelling on the ship or aircraft; and

  2. (b)

    the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and

  3. (c)

    the quantity of the goods must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft; and

  4. (d)

    the goods must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft; and

  1. (e)

    the goods must not be removed from the ship or aircraft while the ship or aircraft is in Australia; and

  2. (f)

    the master of the ship or the pilot of the aircraft must be responsible for the control and custody of the goods while the ship or aircraft is in Australia; and

  3. (g)

    the person mentioned in paragraph (f) must:

    1. (i)

      carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

    2. (ii)

      for each of the goods that is not a therapeutic device — include in the list the generic name and strength of the active ingredient of the goods; and

    3. (iii)

      keep a record of the use of the goods while the ship or aircraft is in Australia; and

    4. (iv)

      produce the list or record for inspection at the request of a customs officer or a person who is an authorised officer for the purposes of a provision of Part 5 of these Regulations.

[16]Schedule 10, Part 1, items 9 and 10

substitute

9

a dialysis solution, except a haemodialysis solution

Schedule 2Amendments of Therapeutic Goods (Medical Devices)

Regulations 2002

(regulation 4)

[1]Schedule 4, item 2.2, paragraph (b)

omit

goods

insert

device

[2]Schedule 4, after item 2.5

insert

2.6

Medical device that is imported into Australia by a medical practitioner or a member of a medical team (being 1 or more persons under the professional supervision of a medical practitioner)

  1. (a)

    The medical practitioner or medical team must be accompanying a person to Australia who:

    1. (i)

      has a critical illness; and

    2. (ii)

      is under the direct care and supervision of the practitioner or team.

  1. (b)

    The device must be for use in the treatment of the person who has the critical illness.

  2. (c)

    The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations 1956.

  3. (d)

    The quantity of the device imported must be consistent with the quantity required for the treatment of the person mentioned in paragraph (b).

  1. (e)

    The device must not be supplied to, or used in the treatment of, a person other than the person mentioned in paragraph (b).

  2. (f)

    The device must be destroyed or removed from Australia at the end of the visit.

  1. (g)

    The medical practitioner, or a member of the medical team, must be responsible for the control and custody of the device while the practitioner or team is in Australia.

  1. (h)

    The person mentioned in paragraph (g) must:

    1. (i)

      carry a list, in English, of the quantity and nature of the device imported; and

    2. (ii)

      keep a record of the use of the device while the medical practitioner or medical team is in Australia; and

    3. (iii)

      produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section 41FN of the Act.

2.7

Medical device that is imported into Australia by a member of a group of persons, being a group that includes a person who is the Head of State or Head of Government of a foreign country and senior Government officials of that country, who are visiting Australia on official business

  1. (a)

    The device must be for use in the treatment of a member or members of the visiting group.

  2. (b)

    The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations 1956.

  3. (c)

    The device must not be supplied to, or used in the treatment of, a person other than a member of the visiting group.

  4. (d)

    The device must be destroyed or removed from Australia at the end of the visit.

  1. (e)

    A member of the visiting group must be responsible for the control and custody of the device while the group is in Australia.

  2. (f)

    The person mentioned in paragraph (e) must:

    1. (i)

      carry a list, in English, of the quantity and nature of the device imported; and

    2. (ii)

      keep a record of the use of the device while the group is in Australia; and

    3. (iii)

      produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section 41FN of the Act.

2.8

Medical device that is part of the medical supplies of a ship (including a yacht or other marine vessel) or aircraft visiting Australia

  1. (a)

    The device must be for use in the treatment of a passenger or a member of the crew travelling on the ship or aircraft.

  2. (b)

    The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations 1956.

  1. (c)

    The quantity of the device imported must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft.

  2. (d)

    The device must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft.

  3. (e)

    The device must not be removed from the ship or aircraft while the ship or aircraft is in Australia.

  1. (f)

    The master of the ship or the pilot of the aircraft must be responsible for the control and custody of the device while the ship or aircraft is in Australia.

  2. (g)

    The person mentioned in paragraph (f) must:

    1. (i)

      carry a list, in English, of the quantity and nature of the device imported; and

    2. (ii)

      keep a record of the use of the device while the ship or aircraft is in Australia; and

    3. (iii)

      produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section 41FN of the Act.

Notes

1. These Regulations amend (in Schedule 1) 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 Nos. 9, 84, 114, 143, 234, 315 and 345; 2003 Nos. 111, 151, 257, 258, 301 and 361.

These Regulations also amend (in Schedule 2) Statutory Rules 2002 No. 236, as amended by 2003 Nos. 153, 259 and 361.

2. Notified in the Commonwealth of Australia Gazette on 30 April 2004.

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