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Therapeutic Goods Amendment Regulations 2001 (No. 1)

Authoritative Version
  • - F2001B00244
  • No longer in force
SR 2001 No. 159 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR06-Aug-2001
Tabled Senate06-Aug-2001
Gazetted 29 Jun 2001
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2001 (No. 1)1

Statutory Rules 2001 No. 1592

I, WILLIAM PATRICK DEANE, 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 28 June 2001



By His Excellency’s Command


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2001 (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]         Regulation 2, after definition of authorised person


Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.

Note 1   The Australian Approved Names List includes:

(a)   Australian Approved Names — Chemicals List; and

(b)   Australian Approved Names — Biological Lists; and

(c)   the Herbal Substances AAN List.

Note 2   The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Medicines.

[2]         Regulation 2, definition of generic information, paragraph (b)


, or associated (directly or indirectly) with,

[3]         Regulation 2, after definition of specialist


specified media, in relation to an advertisement or generic information, means:

                (a)    mainstream media within the meaning of section 42B of the Act; or

               (b)    cinematograph films; or

                (c)    displays about goods, including posters:

                          (i)    in shopping malls (except inside an individual shop); and

                         (ii)    in or on public transport; and

                        (iii)    on billboards.

[4]         Regulation 2, after definition of sporicide


Standard AS/NZS means a joint Australian and New Zealand Standard published by the Standards Australia International Limited and the body known as Standards New Zealand.

[5]         Paragraph 4 (1) (c)


                (c)    persons who are registered under a law of a State or Territory as herbalists, homoeopathic practitioners, chiropractors, naturopaths, nutritionists, practitioners of traditional Chinese medicine, podiatrists or osteopaths.

[6]         Regulation 5B, after definition of approved advertisement


ASMI means Australian Self-Medication Industry Incorporated.

[7]         Regulation 5B, definition of PMAA


[8]         Subregulation 5C (1)


         (1)   This Division applies to advertisements for designated therapeutic goods published or inserted, or intended to be published or inserted, for valuable consideration, in specified media.

[9]         Subregulation 5Q (4)





[10]      Paragraph 6 (1) (e)


                (e)    that refers to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 to the Poisons Standard, except goods or substances or preparations mentioned in Appendix H of the Standard; or

[11]      Paragraph 42B (1) (b)


print and broadcast media;


specified media and broadcast media;

[12]      Before paragraph 42J (2) (a)


              (aa)    the Australian Competition and Consumer Commission; and

[13]      Paragraph 42J (2) (c)




Australia; and

[14]      After paragraph 42J (2) (c)


               (d)    Medsafe, a regulatory agency within the New Zealand Ministry of Health.

[15]      Regulation 42ZCAA, definition of specified media


[16]      Regulation 42ZCAA, note


[17]      Regulation 42ZCAB

after each mention of

specified media


or broadcast media

[18]      Schedule 1, after item 2



Association of Natural Health Practitioners Limited

[19]      Schedule 1, item 5



Australasian Association of Ayurveda Incorporated

[20]      Schedule 1, after item 14



Australian Unani Medicines Society Inc.

[21]      Schedule 2, Part 2, item 1, paragraph (a)


                (a)    vitamins can only be of assistance if the dietary vitamin intake is inadequate; or

[22]      Schedule 4, Part 1, item 7, paragraph (a)


AS/NZS 2604:1997


AS/NZS 2604:1998

[23]      Schedule 4, Part 1, item 10, paragraph (a)


                (a)    the amino acids are tryptophan, arginine, D- or D,L-phenylalanine, D- or D,L-methionine, D- or D,L-carnitine, D- or D,L-glutamic acid or the salts (except the hydrochloride, monoammonium, calcium, magnesium, monosodium and monopotassium salts) of L-glutamic acid; or

[24]      Schedule 5, item 8, subparagraph (g) (i)


AS/NZS 2604:1997


AS/NZS 2604:1998

[25]      Schedule 5A, item 1



Therapeutic goods imported into Australia that are held under the direct control of the sponsor, until the goods are:

   (a)  the subject of a notification under item 3; or

  (b)  approved for importation into Australia under subsection 19 (1) of the Act; or

   (c)  authorised for supply under subsection 19 (5) of the Act; or

  (d)  dispensed as a medicine prescribed for a Category A patient within the meaning of subregulation 12A (5)

   (a)  the supply of the goods must be in accordance with the relevant notification, approval, authorisation or prescription; and

  (b)  the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and

   (c)  if the goods are not used within 12 months of importation:

         (i)   in the case of therapeutic goods other than therapeutic devices — the goods must be destroyed within 1 month of the end of that period; and



        (ii)   in the case of therapeutic devices — the devices must be destroyed or returned to the consignor of the devices within 1 month of the end of that period; and

(d)   the sponsor must:

         (i)   keep records relating to the source and supply of the goods; and

        (ii)   if the goods are destroyed under paragraph (c), keep records relating to the destruction; and

       (iii)   if requested by the Secretary, give the records to the Secretary

[26]      Schedule 7, item 14, paragraph (b)


Joint Standard AS/NZS 2604:1993, published by Standards Australia,


Standard AS/NZS 2604:1998,

[27]      Schedule 7, item 20



Medicinal oxygen cylinders that have been decant filled, transfilled or cascade filled by:

   (a)  a hospital; or

  (b)  an ambulance, fire or rescue service

[28]      Schedule 12, note 1


Note 1   Common name is the name approved under the Australian Approved Names List.  For Australian Approved Names List, see regulation 2.

[29]      Schedule 13, note 1


Note 1   Common name is the name approved under the Australian Approved Names List.  For Australian Approved Names List, see regulation 2.


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.

2.       Notified in the Commonwealth of Australia Gazette on 29 June 2001.