Federal Register of Legislation - Australian Government

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Act No. 84 of 1991 as made
An Act to amend various Acts relating to matters dealt with by the Department of Community Services and Health, and for related purposes
Date of Assent 26 Jun 1991
Date of repeal 10 Mar 2016
Repealed by Amending Acts 1990 to 1999 Repeal Act 2016
 

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84, 1991

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - TABLE OF PROVISIONS

TABLE OF PROVISIONS

PART 1 - PRELIMINARY
Section

1. Short title

2. Commencement
PART 2 - AMENDMENT OF THE HEALTH INSURANCE ACT 1973

3. Principal Act

4. Interpretation

5. Insertion of new section:

19DB. Offence where approval of premises as
accredited pathology laboratory has been revoked

6. Accredited pathology laboratories
PART 3 - AMENDMENT OF THE NATIONAL HEALTH ACT 1953

7. Principal Act

8. Approval of nursing home

9. Statements may be published about satisfaction of
standards for nursing home care

10. Insertion of new sections:

45DB. General information about approved
nursing homes may be made available to the public

45DC. Information about Ministerial action and
other information about approved nursing
homes may be made available to the public

11. Insertion of new section:

45EA. Declaration of non-compliance with conditions

12. Applications for review by Tribunal of certain
decisions under Part V

13. Statements to accompany notification of decisions

14. Certain instruments subject to disallowance
PART 4 - AMENDMENT OF THE NURSING HOMES AND
HOSTELS LEGISLATION AMENDMENT ACT 1986

15. Principal Act

16. Repeal of section 22
PART 5 - AMENDMENT OF THE THERAPEUTIC GOODS ACT 1989

17. Principal Act

18. Interpretation

19. Power to obtain information with respect to therapeutic goods

20. Therapeutic goods, gazetted therapeutic goods
groups and gazetted therapeutic devices groups

21. Australian Register of Therapeutic Goods

22. Applications generally

23. Applications for registration

24. Insertion of new sections:

24A. When evaluation fee due for payment

24B. Payment of evaluation fee by instalments

24C. Recovery of evaluation fee

25. Evaluation of therapeutic goods

26. Repeal of section 27 and substitution of new section:

27. Registration or listing number

27. Conditions on registration or listing

28. Secretary may require information

29. Inspection and variation of entries in Register

30. Time for payment of charges

31. Delegation

32. Release of information

33. Application of amendments - registration or listing applications

34. Application of amendments - time for payment of charges

35. Transitional - grouped therapeutic goods

36. Transitional - prescribed application fees and
approved forms - section 23 of the Principal Act

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - LONG TITLE

An Act to amend various Acts relating to matters dealt with by the
Department of Community Services and Health, and for related purposes

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - PART 1
PART 1 - PRELIMINARY

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 1
Short title

(Assented to 26 June 1991)
1. This Act may be cited as the Community Services and Health Legislation Amendment Act 1991.

(Minister's second reading speech made in-
House of Representatives on 31 May 1991 a.m.
Senate on 6 June 1991)

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 2
Commencement


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2. (1) Subject to this section, this Act commences on the day on which it receives the Royal Assent.
(2) Section 14 commences at the same time as the commencement of section 7 of the Nursing Homes and Hostels Legislation Amendment Act 1986.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - PART 2
PART 2 - AMENDMENT OF THE HEALTH INSURANCE ACT 1973

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 3
Principal Act

3. In this Part, "Principal Act" means the Health Insurance Act 1973.*1* *1* No. 42, as amended. For previous amendments, see No. 58, 1975; Nos. 59, 91, 101, 109 and 157, 1976; No. 75, 1977; Nos. 36, 89 and 133, 1978; Nos. 53 and 123, 1979; No. 132, 1980; Nos. 118 and 176, 1981; Nos. 49, 80 and 112, 1982; Nos. 54 and 139, 1983; Nos. 15, 46, 63, 120, 135 and 165, 1984; Nos. 24, 65, 70, 95 and 167, 1985; Nos. 28, 75 and 94; 1986; Nos. 44, 131, 132 and 141, 1987; Nos. 85, 87, 99 and 155, 1988; No. 95, 1989; Nos. 6, 106 and 141, 1990; and Nos. 68, 70 and 73, 1991.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 4
Interpretation

4. Section 3 of the Principal Act is amended:
(a) by omitting from paragraph (a) of the definition of "professional service" in subsection (1) "medical service" and substituting "service (other than a diagnostic imaging service)";
(b) by omitting from the definition of "professional service" in subsection (1) "being a service" (wherever occurring) and substituting "being a clinically relevant service";
(c) by adding at the end of each of paragraphs (a), (b) and (ba) of the definition of "professional service" in subsection (1) "or";
(d) by omitting paragraphs (d) and (e) of the definition of "professional service" in subsection (1) and substituting the following paragraphs:
"(d) a pathology service that is rendered by or on behalf of an approved pathology practitioner pursuant to a request made in accordance with subsection 16A (4) by:
(i) a treating practitioner; or
(ii) another approved pathology practitioner to whom the
treating practitioner has made a request for the service; or
(e) a pathology service (other than a service referred to in paragraph (d)) that is a clinically relevant service rendered by or on behalf of an approved pathology practitioner other than a medical practitioner; or
(f) a diagnostic imaging service that is rendered by or on behalf of a medical practitioner pursuant to a subsection 16B (1) request; or
(g) a diagnostic imaging service (other than a service referred to in paragraph (f)) that is a clinically relevant service rendered by or on behalf of a medical practitioner.";
(e) by inserting in subsection (1) the following definition:
" `clinically relevant service' means a service rendered by
a medical or dental practitioner or an optometrist that is generally accepted in the medical, dental or optometrical profession (as the case may be) as being necessary for the appropriate treatment of the patient to whom it is rendered;".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 5

5. After section 19DA of the Principal Act the following section is inserted:

Offence where approval of premises as accredited pathology
laboratory has been revoked
"19DB. Where:
(a) the proprietor, or each of the proprietors, of an accredited pathology laboratory is an approved pathology authority; and
(b) the approval of the premises as an accredited pathology laboratory has been revoked;
the proprietor or proprietors must cause to be taken such steps as are reasonable in all the circumstances to ensure that, before a pathology service is rendered in the laboratory:
(c) the approved pathology practitioner by or on behalf of whom the pathology service is to be rendered; and
(d) the person in relation to whom the pathology service is to be rendered or, if that person is in the care of another person, that other person;
are informed that a Medicare benefit would not be payable in respect of the pathology service if it were rendered in the laboratory.
Penalty: $100.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 6
Accredited pathology laboratories

6. Section 23DN of the Principal Act is amended by inserting after subsection (7) the following subsection:
"(7A) Where the Minister revokes the approval of premises as an accredited pathology laboratory otherwise than at the request of the proprietor of the
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premises, the Minister must:
(a) cause a copy of the notice of revocation given under subsection (6) to be published:
(i) in the Gazette; or
(ii) by such other means as the Minister in the circumstances thinks appropriate; and
(b) cause a copy of the notice to be laid before each House of the Parliament within 15 sitting days of that House after the notice has been given by the Minister.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - PART 3
PART 3 - AMENDMENT OF THE NATIONAL HEALTH ACT 1953

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 7
Principal Act

7. In this Part, "Principal Act" means the National Health Act 1953.*2* *2* No. 95, 1953, as amended. For previous amendments, see No. 68, 1955; Nos. 55 and 95, 1956; No. 92, 1957; No. 72, 1959; No. 16, 1961; No. 82, 1962; No. 77, 1963; No. 37, 1964; Nos. 100 and 146, 1965; No. 44, 1966; Nos. 14 and 100, 1967; No. 100, 1968; No. 102, 1969; No. 41, 1970; No. 85, 1971; No. 114, 1972; Nos. 49 and 202, 1973; No. 37, 1974; Nos. 1, 13 and 93, 1975; Nos. 1, 60, 91, 99, 108, 157 and 177, 1976; Nos. 98 and 100, 1977; Nos. 36, 88, 132 and 189, 1978; Nos. 54, 91 and 122, 1979; Nos. 117 and 131, 1980; Nos. 40, 74, 92, 118, 163 and 176, 1981; Nos. 49, 80 and 112, 1982; Nos. 35, 54 and 139, 1983; Nos. 46, 63, 72, 120, 135 and 165, 1984; Nos. 24, 53, 65, 70, 95, 127 and 167, 1985; Nos. 28, 75, 94 and 115, 1986; Nos. 22, 44, 72, 118, 131 and 132, 1987; Nos. 79, 87, 99 and 155, 1988; No. 95, 1989; Nos. 3, 84, 106 and 141, 1990; and Nos. 6, 68, 70 and 73, 1991.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 8
Approval of nursing home

8. Section 40AA of the Principal Act is amended by omitting "and" from the end of paragraph (6) (ce).

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 9
Statements may be published about satisfaction of standards for
nursing home care

9. Section 45DA of the Principal Act is amended:
(a) by omitting from subsection (1) "to each approved nursing home." and substituting the following word and paragraphs:
"to:
(a) an approved nursing home; or
(b) premises that were an approved nursing home at any time during the period of 5 years before the publication of the statement.";
(b) by inserting after paragraph (2) (a) the following paragraph:
"(aa) if those standards have not been satisfied -
information relating to the action that will be taken by the proprietor of the nursing home to ensure that those standards will be satisfied;";
(c) by omitting paragraphs (2) (c) to (h) (inclusive);
(d) by omitting from subsection (5) "the statement" (wherever occurring) and substituting "so much of the statement as does not consist of information covered by paragraph (2) (aa)".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 10

10. After section 45DA of the Principal Act the following sections are inserted:

General information about approved nursing homes may be made
available to the public
"45DB. (1) The Secretary may make available to the public, in any way that the Secretary thinks fit, any or all of the relevant information in relation to:
(a) an approved nursing home; or
(b) premises that were an approved nursing home at any time during the period of 5 years before the information is made available to the public.
"(2) The following is relevant information for the purposes of subsection (1):
(a) the name and address of the nursing home;
(b) the number of beds in the nursing home and the physical size of the nursing home;
(c) the location of the nursing home and its proximity to community facilities, for example, public transport, shops, libraries and community centres;
(d) services provided in the nursing home;
(e) fees imposed, and charges made, in the nursing home;
(f) activities at the nursing home in which the patients may participate;
(g) the name of the proprietor of the nursing home;
(h) the number of vacancies (if any) in the nursing home;
(i) the length of the waiting list (if any) for admission to the nursing home.
"(3) The information made available must not be such as to enable the

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identification of an individual patient of a nursing home.

Information about Ministerial action and other information about
approved nursing homes may be made available to the public
"45DC. (1) The Secretary may make available to the public, in any way that the Secretary thinks fit, any or all of the relevant information in relation to:
(a) an approved nursing home; or
(b) premises that were an approved nursing home at any time during the period of 5 years before the information is made available to the public.
"(2) The following is relevant information for the purposes of subsection (1):
(a) details of action taken by the Minister, whether before or after the commencement of this section, in relation to the nursing home under section 40AA, 40AD, 43A, 44, 44A, 45A, 45E or 45EA;
(b) details of any action the Minister intends to take in relation to the nursing home under section 40AA, 40AD, 43A, 44, 44A, 45A, 45E or 45EA;
(c) such other information (if any) as is specified in the regulations.
"(3) A reference in paragraph (2) (a) to action taken by the Minister under a particular provision includes a reference to:
(a) action taken by the Minister under section 105AAB in relation to a decision of the Minister made under the provision concerned; and
(b) action taken by the Administrative Appeals Tribunal under the Administrative Appeals Tribunal Act 1975 in relation to a review of:
(i) a decision of the Minister made under the provision concerned (including a decision that has been varied under section 105AAB); and
(ii) a decision under section 105AAB to revoke a decision covered by subparagraph (i) of this paragraph.
"(4) A reference in paragraph (2) (b) to action the Minister intends to take under a particular provision includes a reference to action that the Minister intends to take under section 105AAB in relation to a decision of the Minister made under the provision concerned.
"(5) The information made available must not be such as to enable the identification of an individual patient of a nursing home.
"(6) Before making the information available, the Secretary must allow the proprietor of the nursing home not less than 30 days to consider the information and to make submissions to the Secretary about the information.
"(7) If it appears to the Secretary in the light of any submission made by the proprietor that the information should be altered, the Secretary is to alter the information accordingly before it is made available.
"(8) Subsections (6) and (7) do not apply if the Secretary considers that there is an urgent need to make the information available in order to protect the welfare or interests of persons who are, or may become, patients of the nursing home.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 11

11. After section 45E of the Principal Act the following section is inserted:

Declaration of non-compliance with conditions
"45EA. (1) If one or more conditions applicable to an approved nursing home have not been complied with, the Minister may, by written notice served on the proprietor, declare that the home does not satisfy those conditions.
"(2) Where a declaration is in force under subsection (1), the Minister may, by written notice served on the proprietor of the nursing home, determine that, while the declaration remains in force, Commonwealth benefit is not payable to the proprietor of the nursing home in respect of a patient admitted to the nursing home after the making of the determination.
"(3) While a determination under subsection (2) is in force:
(a) Commonwealth benefit is not payable to the proprietor of the nursing home in respect of a patient admitted to the home after the making of the determination; and
(b) the proprietor is obliged to make the deduction required by subsection 40AA (5A) in the amount that would have been required if the determination had not been made and Commonwealth benefit were payable in respect of each patient referred to in paragraph (a).
"(4) On the revocation of a declaration under subsection (1), any determination under subsection (2) ceases to have effect.
"(5) This section does not imply that the Minister may not, in circumstances where the Minister is satisfied of the matter referred to in subsection (1) (whether or not the Minister has taken any action under this section), suspend or revoke the approval of the nursing home concerned as an approved nursing home under section 44 if he or she considers that to be a more appropriate course of action.
"(6) Section 45E does not limit this section.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 12
Applications for review by Tribunal of certain decisions under Part V

12. Section 105AAB of the Principal Act is amended:
(a) by inserting in subsection (1) "or section 45EA" after "45A";
(b) by inserting after subsection (1) the following subsection:
"(1A) This section applies in relation to a decision of the Secretary under
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section 45DB or 45DC as if:
(a) a reference in this section to a reviewable decision included a reference to such a decision of the Secretary; and
(b) a reference in this section to the Minister were a reference to the Secretary.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 13
Statements to accompany notification of decisions

13. Section 105AC of the Principal Act is amended:
(a) by inserting in subsection (1A) "or the Secretary, as the case may be," after "the Minister" (wherever occurring);
(b) by inserting in subsection (1B) "or the Secretary" after "the Minister".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 14
Certain instruments subject to disallowance

14. Section 139B of the Principal Act is amended by inserting before paragraph (1) (b) the following paragraph:
"(ac) a notice under the definition of `Government nursing home' in subsection 4 (1);".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - PART 4
PART 4 - AMENDMENT OF THE NURSING HOMES AND HOSTELS LEGISLATION
AMENDMENT ACT 1986

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 15
Principal Act

15. In this Part, "Principal Act" means the Nursing Homes and Hostels Legislation Amendment Act 1986.*3* *3* No. 115, 1986.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 16
Repeal of section 22

16. Section 22 of the Principal Act is repealed.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - PART 5
PART 5 - AMENDMENT OF THE THERAPEUTIC GOODS ACT 1989

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 17
Principal Act

17. In this Part, "Principal Act" means the Therapeutic Goods Act 1989.*4* *4* No. 21, 1990, as amended. For previous amendments, see No. 141, 1990.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 18
Interpretation

18. Section 3 of the Principal Act is amended by inserting in subsection (1) the following definitions:
" `data processing device' means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device;
`gazetted therapeutic devices group' has the meaning given by subsection 16 (3);
`gazetted therapeutic goods group' has the meaning given by subsection 16 (2);
`grouped therapeutic goods' means therapeutic goods included in:
(a) a gazetted therapeutic goods group; or
(b) a gazetted therapeutic devices group;".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 19
Power to obtain information with respect to therapeutic goods

19. Section 8 of the Principal Act is amended:
(a) by omitting from subsection (1) "in writing" (second occurring);
(b) by inserting after subsection (1) the following subsection:

"(1A) A notice under subsection (1) may require the information to be given:
(a) in writing; or
(b) in accordance with specified software requirements:
(i) on a specified kind of data processing device; or
(ii) by way of a specified kind of electronic transmission.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 20
Therapeutic goods, gazetted therapeutic goods groups and
gazetted therapeutic devices groups

20. Section 16 of the Principal Act is amended:
(a) by omitting from subsection (1) "Subject to this section, therapeutic goods are, for the purposes of this Part," and substituting "For the purposes of this Part, therapeutic goods are";
(b) by omitting from subsection (2) "to be treated as single therapeutic goods for the purposes of this Part" and substituting "a gazetted therapeutic goods group";
(c) by omitting from subsection (3) "to be treated as single therapeutic
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goods for the purposes of this Part" and substituting "a gazetted therapeutic devices group";
(d) by adding at the end the following subsection:
"(4) An order under subsection (2) or (3) may make provision for or in relation to a matter by applying, adopting or incorporating, with or without modification, a document as in force from time to time, if the document is:
(a) published by the Department (whether in electronic form or otherwise); and
(b) available for sale to the public; and
(c) available for inspection (whether by using a visual display unit or otherwise) by the public at offices of the Department specified by the Secretary.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 21
Australian Register of Therapeutic Goods

21. Section 17 of the Principal Act is amended by adding at the end of subsection (4) the following word and paragraph:
"; and (c) prescribe the ways in which goods that have been assigned a registration or listing number may be assigned a different registration or listing number.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 22
Applications generally

22. Section 23 of the Principal Act is amended:
(a) by inserting in paragraph (a) ", in writing," after "approved" (wherever occurring);
(b) by omitting from paragraph (b) "Secretary; and" and substituting "Secretary.";
(c) by omitting paragraphs (c) and (d);
(d) by adding at the end the following subsections:
"(2) An application is not effective unless:
(a) if:
(i) the goods are not grouped therapeutic goods; or
(ii) the goods are grouped therapeutic goods but no other goods included in the gazetted therapeutic devices group or the gazetted therapeutic goods group concerned have been registered or listed, as the case requires, in relation to the applicant;
the prescribed application fee has been paid; and
(b) the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and
(c) if the Secretary so requires - the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods.

"(3) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 23
Applications for registration

23. Section 24 of the Principal Act is amended:
(a) by inserting in subsection (1) "by the applicant" after "payable";
(b) by omitting subsection (2) and substituting the following subsection:
"(2) An application for registration of therapeutic goods lapses if any part of the evaluation fee payable in respect of those goods remains unpaid at the end of the period of 2 months after the day on which the amount became due and payable.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 24

24. After section 24 of the Principal Act the following sections are inserted:

When evaluation fee due for payment
"24A. Subject to section 24B, an evaluation fee under section 24 payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

Payment of evaluation fee by instalments
"24B. (1) The regulations may provide for the payment of an evaluation fee under section 24 to be made by such instalments and at such times as are ascertained in accordance with the regulations, and the evaluation fee is due and payable accordingly.
"(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment.
"(3) Subsection (2) does not limit the generality of subsection (1).

Recovery of evaluation fee
"24C. An evaluation fee under section 24 may be recovered by the Commonwealth as a debt due to the Commonwealth.".

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COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 25
Evaluation of therapeutic goods

25. Section 25 of the Principal Act is amended by omitting paragraph (1) (b) and substituting the following paragraph:
"(b) there is no part of an evaluation fee under section 24 in respect of those goods that:
(i) is due and payable by the person; and
(ii) remains unpaid; and".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 26

26. Section 27 of the Principal Act is repealed and the following section is substituted:

Registration or listing number
"27. (1) Where the Secretary includes therapeutic goods (other than grouped therapeutic goods) in the Register, the Secretary is to assign a unique registration or listing number to the goods.
"(2) Where the Secretary includes grouped therapeutic goods in the Register, the Secretary is to assign a single, unique registration or listing number to the grouped therapeutic goods.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 27
Conditions on registration or listing

27. Section 28 of the Principal Act is amended:
(a) by inserting after subsection (3) the following subsection:

"(3A) The Secretary's power under subsection (3) may be exercised at the request of the person concerned or of the Secretary's own motion.";
(b) by adding at the end the following subsection:

"(6) The regulations may make provision in relation to the charging of fees in respect of requests under subsection (3A).".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 28
Secretary may require information

28. Section 31 of the Principal Act is amended by adding at the end the following subsection:
"(3) An approval of a form may require or permit information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 29
Inspection and variation of entries in Register

29. Section 32 of the Principal Act is amended by inserting after subsection (2) the following subsection:
"(2A) If a person makes such a request, then, instead of providing a copy of an entry to the person, the Secretary may, if the request is for the provision of the copy in an electronic form, provide the information contained in the entry:
(a) on a data processing device; or
(b) by way of electronic transmission.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 30
Time for payment of charges

30. Section 44 of the Principal Act is amended:
(a) by inserting in subsection (1) "that relates to therapeutic goods other than grouped therapeutic goods" after "financial year" (first occurring);
(b) by inserting after subsection (1) the following subsection:
"(1A) An annual registration charge or annual listing charge for a financial year that relates to grouped therapeutic goods becomes payable by a person on the day specified in relation to those grouped therapeutic goods in a written notice given by the Secretary to the person.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 31
Delegation

31. Section 57 of the Principal Act is amended:
(a) by inserting in subsection (2) "under subsection (1)" after "delegated";
(b) by adding at the end the following subsections:
"(3) Subject to the regulations, the Secretary may, in such circumstances as are prescribed, by signed instrument, delegate all or any of his or her powers under paragraph 19 (1) (a) to a person who is registered, in a State or internal Territory, as a medical or dental practitioner.
"(4) A delegate under subsection (3) is, in the exercise of a delegated power, subject to the directions of the Secretary or of an officer of the Department authorised, in writing, by the Secretary.
"(5) Without limiting the generality of matters that may be dealt with by regulations made for the purposes of subsection (3), the regulations may make provision in relation to the following:
(a) the persons who may be delegates;
(b) the circumstances in which delegates may grant approvals for the
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purposes of paragraph 19 (1) (a);
(c) the conditions to which any approvals granted by delegates are to be subject;
(d) requiring information to be given by delegates to the Secretary.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 32
Release of information

32. Section 61 of the Principal Act is amended by inserting after subsection (8) the following subsections:
"(8A) The regulations may make provision in relation to the charging of fees in respect of applications for information under subsection (6), including requiring deposits on account of such fees.
"(8B) Without limiting the generality of regulations that may be made for the purposes of subsection (8A), those regulations:
(a) may provide for a fee that takes into account the time that is spent by the Department in undertaking any of the following activities:
(i) searching for or retrieving information;
(ii) making, or doing things related to making, a decision on an application for information; and
(b) may provide for a fee that takes into account the direct costs incurred by the Department in making available an officer to supervise the inspection by the person of any document that contains information for which an application for release has been made under subsection (6).
"(8C) If, in accordance with regulations made for the purposes of subsection (8A), a person is liable to pay a fee in respect of an application for information, the Secretary must notify the person, in writing, accordingly, and must give to the person, together with that notification, a statement setting out the basis on which the amount of that fee is calculated.".

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 33
Application of amendments - registration or listing applications

33. The amendments made by sections 22, 23, 24 and 25 apply to applications made on or after the date of the commencement of this section.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 34
Application of amendments - time for payment of charges

34. The amendments made by section 30 apply as follows:
(a) in the case of the financial year in which the date of the commencement of this section occurred - to registrations or listings that commenced on or after that date;
(b) in the case of a later financial year - to all registrations or listings.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 35
Transitional - grouped therapeutic goods

35. (1) In this section:
"amended Act" means the Principal Act as amended by this Act;
"deemed single therapeutic goods" means therapeutic goods which, under section 16 of the Principal Act, are treated as single therapeutic goods for the purposes of Part 3 of the Principal Act.
(2) For the purposes of the amended Act, an order under subsection 16 (2) of the Principal Act determining that a group of goods is to be treated as single therapeutic goods has effect as if it were an order under subsection 16 (2) of the amended Act determining that the group is a gazetted therapeutic goods group.
(3) For the purposes of the amended Act, an order under subsection 16 (3) of the Principal Act determining that a group of goods is to be treated as single therapeutic goods has effect as if it were an order under subsection 16 (3) of the amended Act determining that the group is a gazetted therapeutic devices group.
(4) For the purposes of the amended Act, a notice under section 19 or 31 of the Principal Act relating to deemed single therapeutic goods has effect as if it were a notice relating to the corresponding grouped therapeutic goods.
(5) For the purposes of the amended Act, an application for registration or listing of deemed single therapeutic goods under section 23 of the Principal Act has effect as if it were an application for registration or listing, as the case may be, of the corresponding grouped therapeutic goods.
(6) If a registration or listing (in this subsection called the "original registration or listing") of deemed single therapeutic goods is in force immediately before the commencement of this subsection, the amended Act has effect, after the commencement of this subsection, as if a registration or listing, as the case may be, of each of the corresponding grouped therapeutic goods had commenced at the original registration or listing.
(7) For the purposes of the amended Act, an assignment of a registration or listing number to therapeutic goods other than deemed single therapeutic goods under section 27 of the Principal Act has effect as if it had been made under subsection 27 (1) of the amended Act.
(8) For the purposes of the amended Act, an assignment of a registration or listing number to deemed single therapeutic goods under section 27 of the Principal Act has effect as if it had been an assignment to the corresponding grouped therapeutic goods under subsection 27 (2) of the amended Act.
(9) For the purposes of the application of Part 5 of the Principal Act to charges:
(a) for the financial year in which the date of commencement of this section occurred or an earlier financial year; and
(b) in respect of registrations or listings:
(i) in force at a particular time before that date; and
(ii) that commenced before that date;
if therapeutic goods were treated, at that time, as single therapeutic goods for the purposes of Part 3 of the Principal Act, then those goods are taken to have been treated as single therapeutic goods.

COMMUNITY SERVICES AND HEALTH LEGISLATION AMENDMENT ACT 1991 No. 84 of 1991 - SECT 36
Transitional - prescribed application fees and approved forms -
section 23 of the Principal Act

36. (1) In this section:
"amended Act" means the Principal Act as amended by this Act.
(2) For the purposes of the amended Act, an application fee prescribed for the purposes of a provision of section 23 of the Principal Act has effect as if it had been prescribed for the purposes of the corresponding provision of section 23 of the amended Act.
(3) For the purposes of the amended Act, a form approved for the purposes of a provision of section 23 of the Principal Act has effect as if it had been approved for the purposes of the corresponding provision of section 23 of the amended Act.