Therapeutic Goods Regulations (Amendment) (Cth)

Case
No judgment structure available for this case.

Statutory Rules 1994

No. 150 1

__________________

Therapeutic Goods Regulations 2 (Amendment)

I, The Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic GoodsAct 1989.

Dated 1 June 1994.

 BILL HAYDEN

 Governor-General

By His Excellency’s Command,

ROSEMARY CROWLEY

Minister for Family Services

____________

1.   Amendment

1.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

[NOTE: These Regulations commence on gazettal: see Acts Interpretation Act 1901, s. 48.]

2.   Regulation 11 (Listed goods)

2.1   Subregulation 11 (2):

Omit the subregulation.

3.   New regulation 11A

3.1   After regulation 11, insert:

Guidelines for the assessment of intraocular lenses

“11A.

(1) Subregulation (2) applies if:

  • (a)

    an intraocular lens of a kind referred to in item 13 of Part 1 of Schedule 4 is included in the Register:

    • (i)

      after being evaluated under section 25 of the Act for registration; or

    • (ii)

      in accordance with subsection 66 (3) of the Act; and

  • (b)

    the sponsor of the lens seeks the inclusion in the Register of an intraocular lens that is derived from the lens referred to in paragraph (a).

“(2)

The Secretary may approve, in writing, guidelines to be used for the purposes of item 14 of Part 1 of Schedule 4 to determine the extent to which the derived intraocular lens is permitted to differ from the lens from which it is derived.”.

4.   Regulation 17 (Exempt goods for the purposes of subsection 34 (1) of the Act)

4.1   Add at the end:

“(2)

If:

  • (a)

    therapeutic goods that are exempt from the operation of Part 4 of the Act cease to be exempt; and

  • (b)

    before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;

the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.”.

5.   Regulation 23 (Interpretation)

5.1   Insert the following definitions:

“ ‘responsible analyst’, in relation to the analysis of a sample of therapeutic goods, means an official analyst who is nominated as a responsible analyst for the sample under paragraph 25 (3) (c);

‘samples officer’ means an officer of the Department performing duties under the direction of an official analyst.”.

6.   Regulation 25 (Official analysts)

6.1   Add at the end:

“(3)

In addition to the other powers and functions of an official analyst, an official analyst may:

  • (a)

    ask an authorised officer to take samples of therapeutic goods; and

  • (b)

    determine the tests that are to be performed on the sample; and

  • (c)

    nominate an official analyst to be the responsible analyst for the sample.”.

7.   Regulation 26 (Taking of samples for testing)

7.1   Paragraph 26 (1) (a):

Omit “an official analyst”, substitute “a laboratory operated by the Department”.

7.2   Paragraph 26 (1) (c):

Omit “an official analyst.”, substitute “the relevant laboratory.”.

8.   Regulation 27 (Examination and testing by official analyst)

8.1   Omit the regulation, substitute:

Examination and testing of sample

“27.

(1)A samples officer must, as soon as practicable after receiving a sample of goods at a laboratory operated by the Department:

  • (a)

    determine whether the sample is appropriately packaged, fastened and sealed; and

  • (b)

    if the sample is appropriately packaged, fastened and sealed—store the sample under the officer’s control and under secure conditions that are appropriate to the kind of goods.

 “(2)The responsible analyst must, as soon as practicable, collect the sample from the samples officer and arrange for:

  • (a)

    an analysis of the sample by relevant tests to the extent the analyst considers necessary to establish:

    • (i)

      the quantity and quality of the goods comprising the sample; and

    • (ii)

      any other matter relevant to determining whether the goods from which the sample was taken comply with any standard applicable to them or with conditions relating to matters referred to in paragraph 28 (2) (d) of the Act; and

  • (b)

    an examination of the goods, the label (if any) relating to the goods and the packaging of the goods, to determine whether the goods comply with the labelling, packaging and other requirements (including requirements relating to advertising) applicable to the goods.”.

9.   Regulation 29 (Certificate of official analyst)

9.1   Subregulation 29 (1):

Omit “An official analyst who has arranged and supervised the analysis of a sample of goods”, substitute “The responsible analyst”.

9.2   Subregulation 29 (1):

Omit “the official analyst”, substitute “him or her”.

9.3   Subregulation 29 (2):

Omit the subregulation, substitute:

 “(2)The responsible analyst must send a copy of the certificate, signed by him or her, to:

  • (a)

    the Secretary; and

  • (b)

    the person from whom the sample was taken, if that person is not the sponsor of the goods.”.

9.4   Subregulation 29 (4):

Omit “A certificate referred to in subregulation (1),”, substitute “If the certificate referred to in subregulation (1) states that the relevant goods do not conform to a specified standard, or requirement, that is applicable to the goods within the meaning of regulation 27, the certificate,”.

9.5   Paragraph 29 (4) (a):

After “reviewed”, insert “in accordance with regulation 30”.

10.   Regulation 32 (Offences relating to analysis etc.)

10.1   Paragraph 32 (1) (c):

Omit “the official analyst” (first occurring), substitute “an official analyst”.

11.   Schedule 1 (Part 2 does not apply to members of an Australian branch of one of these bodies)

11.1   After item 3, insert:

“3A  Aust-China Acupuncture and Chinese Medicine Association Inc.”.

11.2   Items 4 and 5:

Omit the items, substitute:

“4 Australian Acupuncture Association Ltd.

5 Australian Association of Ayurveda”.

11.3   Item 8:

Omit the item, substitute:

“8 Australian Federation of Homeopaths (WA) Inc.”.

11.4   After item 9, insert:

“9A Australian Federation of Homoeopaths (Qld.) Inc.”.

11.5   After item 15, insert:

“15A  Chinese Medicine Association of Australia Inc.”.

11.6   After item 16, insert:

“16A Federation of Chinese Medicine and Acupuncture Societies of Australia”.

11.7   After item 18, insert:

“18A Naturopathic Physicians Association of Australia Inc.”.

11.8   After item 19, insert:

“19A Queensland Society of Homeopaths Inc.”.

11.9   Item 21:

Omit the item, substitute:

“21 Society of Natural Therapists and Researchers [SNTR] Inc.”.

12.   Schedule 2 (Prohibited and required representations for the purposes of paragraphs 6 (1) (a) and (b))

12.1   Part 3, item 4 (column 3):

Omit “Vitamin B3”.

13.   Schedule 3 (Therapeutic goods required to be included in the part of the Register for registered goods)

13.1   Part 1, paragraph 3 (a):

Omit the paragraph, substitute:

  • “(a)

    implantable intra-ocular lenses, other than lenses that are included in item 13 or 14 of Part 1 of Schedule 4.”.

13.2   Part 1, paragraph 3 (f):

Omit the paragraph, substitute:

  • “(f)

    powered drug infusion systems and accessories that regulate the flow of infusate, other than:

    • (i)

      non-implantable powered drug infusion systems where the only regulation of flow that is achieved is done by driving a pressurised fluid through a thin calibrated bore restricter that does not allow for any adjustment to be made to the flow rate; or

    • (ii)

      accessories to systems referred to in subparagraph (i); or”.

13.3   Part 2, item 2:

Add at the end:

 “, other than pumps where the only regulation of flow that is achieved is done by driving a pressurised fluid through a thin calibrated bore restricter that does not allow for any adjustment to be made to the flow rate”.

14.   Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods)

14.1   Part 1, paragraph 2 (a):

After “item 3 of”, insert “Part 1 of”.

14.2   After paragraph 2 (a) of Part 1, insert:

  • “(aa)

    Part 2 of Schedule 3 applies; or”.

14.3   Part 1, item 4:

Omit the item, substitute:

“4 mother tinctures

4A homoeopathic preparations that:

  • (a)

    consist of, or contain a dilution of, mother tincture that:

    • (i)

      is a 1,000-fold dilution, or a lesser dilution, of that mother tincture; and

    • (ii)

      is not required to be sterile; and

    • (iii)

      is not subject to a Schedule to the Poisons Standard otherwise than because of a component that is more than a 1,000-fold dilution of a mother tincture; and

  • (b)

    do not consist of, or contain as a component, a preparation of a herb specified in Part 4 of this Schedule as a 1,000-fold dilution, or a lesser dilution, of a mother tincture”.

14.4   Part 1, item 7:

Omit “Australian Standard AS2604—1986 as amended and in force”, substitute “Joint Standard AS/NZS 2604:1993, published by Standards Australia, as in force”.

14.5   Part 1, item 11:

Omit paragraph (b), substitute:

  • “(b)

    partly of therapeutic devices and partly of drugs;

if Part 3 of the Act applies to any of the individual therapeutic goods contained in the kit”.

14.6   Part 1, item 12:

Add at the end “if Part 3 of the Act applies to any of the individual therapeutic goods contained in the kit”.

14.7   Add at the end of Part 1:

“13 intraocular lenses that are:

  • (a)

    made of polymethyl methacrylate; and

  • (b)

    designed for placement in the posterior chamber of the eye; and

  • (c)

    monofocal; and

  • (d)

    included in the Register:

    • (i)

      after being evaluated under section 25 of the Act for registration; or

    • (ii)

      in accordance with subsection 66 (3) of the Act; and

14 intraocular lenses that:

  • (a)

    are derived from a lens of a kind referred to in item 13; and

  • (b)

    do not differ from the lens from which they are derived except to the extent permitted by guidelines made under regulation 11A”.

14.8   Part 4:

Insert the following item:

“Teucrium chamaedrys Wall germander”.

15.   Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

15.1   Paragraph 1 (b):

After “Act”, insert “, or are insulin preparations”.

15.2   Paragraph 1 (c):

Omit the paragraph, substitute:

  • “(c)

    in the case of other drugs:

    • (i)

      the quantity imported in one importation is not more than 3 months’ supply at the maximum dose recommended by the manufacturer; and

    • (ii)

      the total quantity of the drug imported for use in the treatment of the importer or the importer’s immediate family in the period of 12 months ending on the day on which the latest importation occurs does not exceed 15 months’ supply of the drug at the maximum dose recommended by the manufacturer;

 or the drugs have been approved, or are included in a class of drugs that has been approved, under regulation 5 of the Customs (Prohibited Imports) Regulations for importation into Australia; and”.

15.3   Item 6:

Omit the item, substitute:

“5 custom-made therapeutic devices that are produced for a particular person for therapeutic application to that person, other than the following goods:

  • (a)

    therapeutic devices referred to in item 3 of Part 1 of Schedule 3;

  • (b)

    therapeutic devices referred to in an item in Part 2 of Schedule 3;

  • (c)

    electronic devices that must be programmed for each patient using those devices

“6 drugs that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person”.

15.4   Paragraph 7 (b):

Add at the end of the item:

  • “(v)

    containers of a kind referred to in paragraph 7 (l); or”.

15.5   Paragraph 7 (f):

Omit the paragraph, substitute:

  • “(f)

    therapeutic devices for dental use that are:

    • (i)

      constructed externally to the mouth; and

    • (ii)

      fitted or fixed into the mouth on a temporary or permanent basis; and

    • (iii)

      intended for protection, or to correct an irregularity or deficiency;

 other than the following:

  • (iv)

    devices of human or animal origin;

  • (v)

    dental restorative materials;

  • (vi)

    devices that, when used, are implanted directly into bone or soft tissue;

  • (vii)

    therapeutic devices for dental use included in an item in Schedule 3 or 4; or

  • (fa)

    therapeutic devices for dental use that are dental impression materials; or”.

15.6   Paragraph 7 (l):

Omit the paragraph, substitute:

  • “(l)

    containers other than:

    • (i)

      syringes; or

    • (ii)

      single use containers designed for the collection, directly from a person, of blood for diagnostic testing; or

    • (iii)

      containers designed for the collection of blood for transfusion; or

    • (iv)

      containers designed for the collection of blood for use in the manufacture of blood products; or

    • (v)

      containers designed for the storage of blood and blood components for parenteral administration; or

    • (vi)

      containers, not made of glass, designed for the storage and parenteral administration of therapeutic goods (commonly referred to as ‘large volume parenteral infusion bags’); or

    • (vii)

      bags designed for the collection of fluids drained from the body of a patient (commonly referred to as ‘drainage bags’); or”.

15.7   Paragraph 8 (g):

Omit the paragraph, substitute:

  • “(g)

    sunscreen preparations for dermal use that:

    • (i)

      are packaged in containers the labels of which include a statement that the preparations have a sun protection factor below 4 or the equivalent category description; and

    • (ii)

      when tested as described in Joint Standard AS/NZS 2604:1993, published by Standards Australia, as in force from time to time, are established to have a sun protection factor below 4 or the equivalent category description”.

15.8   Add at the end:

“12 allergens for skin patch testing on unbroken skin, whether or not the allergen is also described in an item in Schedule 3 or 4”.

16.   Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)

16.1   Item 3:

Omit the item, substitute:

“3

Therapeutic goods used solely for experimental purposes in humans

(a) before starting to use the goods, the sponsor must notify the Secretary:

(i) in a form approved by the Secretary; and

(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;

 that the sponsor intends to sponsor a clinical trial using specified goods; and

(b) the notification must be accompanied by the relevant notification fee referred to in item 14 or 14A of Schedule 9; and

(c) the approval of the goods for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial; and

(d) the terms of the approval by the sponsor, body or organisation referred to in paragraph (c) must be no less restrictive than the terms advised by the ethics committee; and

(e) the Secretary must not, at any time:

(i) have become aware that to conduct or continue the trial would be contrary to the public interest; and

(ii) have directed that the trial not be conducted, or be stopped; and

(f) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must not receive, or have received, advice from the ethics committee that is inconsistent with the continuation of the trial.

4

Therapeutic goods that are imported by a member of a group of persons

(a) the group must be visiting Australia to participate in a national or an international sporting event; and

(b) the goods must be for use in the treatment of a member or members of that group; and

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

(d) the goods must not be supplied to, or used in the treatment of, a person who is not a member of the visiting group; and

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

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

(g) the person referred to in paragraph (f) must:

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

(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

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

(iv) produce the list or the 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”.

17.   Schedule 6 (Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act)

17.1   Paragraph 3 (b):

Omit the paragraph, substitute:

  • “(b)

    dental restorative materials; or”.

17.2   Item 4:

Omit the item, substitute:

“4 a container of a kind referred to in item 5 of Schedule 7”.

18.   Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits)

18.1   Paragraph 4 (b):

Omit the paragraph, substitute:

  • “(b)

    dental restorative materials; or”.

18.2   Item 5:

Omit the item, substitute:

“5 containers other than:

  • (a)

    sterile syringes; or

  • (b)

    single use containers designed for the collection, directly from a person, of blood for diagnostic testing; or

  • (c)

    containers designed for the collection of blood for transfusion; or

  • (d)

    containers designed for the collection of blood for use in the manufacture of blood products; or

  • (e)

    containers designed for the storage of blood and blood components for parenteral administration; or

  • (f)

    containers, not made of glass, designed for the storage and parenteral administration of therapeutic goods (commonly referred to as ‘large volume parenteral infusion bags’); or

  • (g)

    bags designed for the collection of fluids drained from the body of a patient (commonly referred to as ‘drainage bags’)”.

18.3   Item 14:

Omit the item, substitute:

“14 sunscreen preparations for dermal use that:

  • (a)

    are packaged in containers the labels of which include a statement that the preparations have a sun protection factor below 4 or the equivalent category description; and

  • (b)

    when tested as described in Joint Standard AS/NZS 2604:1993, published by Standards Australia, as in force from time to time, are established to have a sun protection factor below 4 or the equivalent category description”.

18.4   Add at the end:

“19 allergens for skin patch testing on unbroken skin”.

19.   Schedule 8 (Persons exempt from the operation of Part 4 of the Act)

19.1   Column 2 of item 4:

After “naturopaths”, insert “, practitioners of traditional Chinese medicine”.

20.   Schedule 9 (Fees)

20.1   Item 1 (column 2, paragraph (a)):

Omit the paragraph, substitute:

“(a) if:

(i)

the goods are drugs for use solely for experimental purposes in humans; and

(ii)

the evaluation consists of the consideration of:

  • (A)

    a summary of chemical, pharmaceutical and biological information about the goods; and

  • (B)

    descriptive information about the proposed clinical trial of the goods; and

  • (C)

    information about adverse events associated with the use of the goods; and

  • (D)

    information about the goods provided to the relevant ethics committee

for each drug—800”.

20.2   Paragraph 1 (c):

After “item 3 of”, insert “Part 1 of”.

20.3   Item 10:

Omit the item, substitute:

“10

fee for an application for certification under paragraph 58 (3) (a) of the Act

50 multiplied by the number of certifications sought in the application”.

20.4   Item 14:

Omit the item, substitute:

“14

fee for notification of intention to sponsor a clinical trial using a specified drug:

(a) if the sponsor of the drug notifies the Secretary, in accordance with item 3 of Schedule 5A, of 1 body or organisation conducting the trial for the sponsor, including the sponsor, if the sponsor is conducting the trial (whether or not the sponsor has previously notified the Secretary of 1 or more bodies or organisations conducting the trial)

90

(b) if the sponsor of the drug notifies the Secretary, in accordance with item 3 of Schedule 5A, of 2 or more bodies or organisations conducting the trial for the sponsor, including the sponsor, if the sponsor is conducting the trial (whether or not the sponsor has previously notified the Secretary of 1 or more bodies or organisations conducting the trial)

180

14A

fee for notification of intention to conduct a clinical trial using a specified therapeutic device, if the sponsor of the drug notifies the Secretary, in accordance with item 3 of Schedule 5A, of 1 or more bodies or organisations conducting the trial for the sponsor, including the sponsor, if the sponsor is conducting the trial (whether or not the sponsor has previously notified the Secretary of 1 or more bodies or organisations conducting the trial)

90”.

21.   Schedule 10 (Drugs evaluated by the Drug Evaluation Branch of the Department)

21.1   Item 1

Omit the item, substitute:

“1 drugs containing chemical entities that are not present in drugs included in the Register for supply in Australia

1A drugs containing biological entities of human or animal origin that are not present in drugs included in the Register for supply in Australia”.

21.2   Item 5

Omit the item, substitute:

“5 allergens, other than allergens for skin patch testing on unbroken skin”.

22.   Date of effect of revocation of exemptions

22.1   For the purposes of subsections 18 (3) and 34 (3) of the Therapeutic Goods Act 1989, the revocations of exemptions made by subregulations 15.6, 17.2, 18.2 and 18.3 of these Regulations take effect on 1 July 1994.

 NOTES

1. Notified in the Commonwealth of Australia Gazette on 2 June 1994.

2. Statutory Rules 1990 No. 88 amended by 1990 No. 394; 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141.

Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0