THERAPEUTIC GOODS REGULATIONS
- Incorporating all amendments by legislation made to 31 October 1980
- Reprinted as at 31 October 1980 (HISTREG CHAP 52 #DATE 31:10:1980)
*1*The Therapeutic Goods Regulations (in force under the Therapeutic Goods Act 1966) as shown in this reprint comprise Statutory Rules 1970 No. 165 as amended by the other Statutory Rules specified in the following table: ------------------------------------------------------------------------------ Date of Application, saving Year and notification Date of or transitional number in Gazette commencement provisions ------------------------------------------------------------------------------ 1970 No. 165 29 Oct 1970 12 Nov 1970 (see r.2 and Gazette 1970, p. 7655) 1973 No. 76 12 Apr 1973 12 Apr 1973 R. 2 225 22 Nov 1973 2 Apr 1973 - 1974 No. 166 25 Sept 1974 25 Sept 1974 - 1975 No. 36 26 Mar 1975 26 Mar 1975 - 1979 No. 135 10 July 1979 10 July 1979 - ------------------------------------------------------------------------------ THERAPEUTIC GOODS REGULATIONS - TABLE OF PROVISIONS
TABLE
TABLE OF PROVISIONS
PART I - PRELIMINARY
Regulation
1. Citation
2. Commencement
3. Parts
4. Interpretation
PART II - EXAMINATION, TESTING AND ANALYSING OF GOODS
5. Interpretation
6. Authorized person for the purposes of section 24 of the Act
7. Power of authorized persons
8. Appointment of laboratories
9. Appointment of official analysts
10. Taking of samples for testing
11. Examination, & c., by official analyst
12. Certificate of official analyst
13. Review of examination, & c., of official analyst
14. Relevant tests of goods
15. Payment for samples
16. Offences
PART III - COMMITTEES
17. Therapeutic Goods Advisory Committee
18. Therapeutic Goods Standards Committee
19. Australian Drug Evaluation Committee
20. Minister may seek further advice
21. Chairman of Committees
22. Tenure of office of members
23. Meetings of Committees
24. Powers and functions of Committee where vacancy occurs
25. Remuneration and allowances of members of Committees
THERAPEUTIC GOODS REGULATIONS - PART I
PART I - PRELIMINARY
THERAPEUTIC GOODS REGULATIONS - REG 1
Citation
1. These Regulations may be cited as the Therapeutic Goods Regulations.*1*
SEE NOTES TO FIRST ARTICLE OF THIS CHAPTER .
THERAPEUTIC GOODS REGULATIONS - REG 2
Commencement
2. These Regulations shall come into operation on the day fixed under
section 2 of the Act*1*
SEE NOTES TO FIRST ARTICLE OF THIS CHAPTER .
THERAPEUTIC GOODS REGULATIONS - REG 3
Parts
3. These Regulations are divided into Parts as follows:
Part I - Preliminary (Regulations 1-4)
Part II - Examination, Testing and Analysing of Goods (Regulations
5-16)
Part III - Committees (Regulations 17-25).
THERAPEUTIC GOODS REGULATIONS - REG 4
Interpretation
4. In these Regulations, unless the contrary intention appears -
"official analyst" means the person holding, or performing the duties
of, the office referred to in sub-regulation (1) of regulation 9 of
these Regulations or a person appointed to be an official analyst
under sub-regulation (2) of that regulation;
"the Act" means the Therapeutic Goods Act 1966;
"the Director-General" means the Director-General of Health.
THERAPEUTIC GOODS REGULATIONS - PART II
PART II - EXAMINATION, TESTING AND ANALYSING OF
GOODS
THERAPEUTIC GOODS REGULATIONS - REG 5
Interpretation
5. In this Part, "authorized person" means a person appointed by the
Director-General under the next succeeding regulation to be an authorized
person.
THERAPEUTIC GOODS REGULATIONS - REG 6
Authorized person for the purposes of section 24 of the Act
6. The Director-General may, by writing under his hand, appoint a person to
be an authorized person for the purposes of this Part.
THERAPEUTIC GOODS REGULATIONS - REG 7
Power of authorized persons
7. An authorized person is empowered, at all reasonable times and on
production of his authority -
(a) to take, and to enter upon premises for the purpose of taking,
samples of goods to which section 24 of the Act applies; and
(b) to make examinations and inquiries with respect to matters
relating
to goods to which section 24 of the Act applies.
THERAPEUTIC GOODS REGULATIONS - REG 8
Appointment of laboratories
Amended by 1974 No. 166 r. 1
8. The following laboratories are appointed as laboratories for the
examination, testing and analysing of goods to which section 24 of the Act
applies:
(a) the National Biological Standards Laboratory;
(b) the Australian Government Analytical Laboratories; and
(c) the Australian Dental Standards Laboratory.
THERAPEUTIC GOODS REGULATIONS - REG 9
Appointment of official analysts
9. (1) The person for the time being holding the office, or performing the
duties of the office, of Director of the National Biological Standards
Laboratory is an official analyst for the purposes of these Regulations.
(2) The Director-General may, by writing under his hand, appoint a person
who has the necessary qualifications to be an official analyst for the
purposes of these Regulations.
THERAPEUTIC GOODS REGULATIONS - REG 10
Taking of samples for testing
10. (1) Where an authorized person has taken a sample of goods to which
section 24 of the Act applies, the authorized person -
(a) shall forthwith notify the person from whom the sample was
taken of the intention of the authorized person to submit the
sample to an official analyst for the carrying out of examinations,
tests and analyses under these Regulations; and
(b) shall then -
(i) in a case where it is practicable so to do - divide the
sample into three parts and fasten and seal each part in
accordance with sub-regulation (4) of this regulation; or
(ii) in any other case - fasten and seal the whole sample in
accordance with sub-regulation (4) of this regulation.
(2) Where the sample is divided into three parts, the authorized person
shall -
(a) forward one part to the person from whom the sample was taken;
(b) forward another part to an official analyst for the carrying out of
examinations, tests and analyses under these Regulations; and
(c) retain the remaining part.
(3) Where the sample is not divided into three parts, the authorized person
shall forward the whole sample to an official analyst for the carrying out of
examinations, tests and analyses.
(4) Where, under sub-regulation (1) of this regulation, a sample is
required, or parts of a sample are required, to be fastened and sealed, the
sample or parts of a sample shall be so fastened and sealed in a vessel or
package marked with the name and address of the person from whom the sample
was taken as to prevent the opening of the vessel or package, or the removal
of that name and address, without breaking the seal.
THERAPEUTIC GOODS REGULATIONS - REG 11
Examination, &c., by official analyst
11. (1) Subject to the next succeeding sub-regulation, an official analyst
shall, as soon as practicable after the receipt by him of a sample or part of
a sample of goods forwarded to him by an authorized person -
(a) carry out, at a laboratory appointed under regulation 8 of these
Regulations, in accordance with any relevant tests, such
examinations,
tests and analyses as are necessary to establish the
composition,
strength, potency, stability, sterility, quantity, quality and
method of preparation of the goods comprising the sample or
part of the sample and to establish any other matter relevant to
determining whether the goods from which the sample was taken
comply with the standard or standards applicable to them; and
(b) examine the goods, the label relating to the goods and the
manner
in which the goods have been packed, including the container
in which the goods were packed, to determine whether the goods
comply with all or any of the labelling and packaging
requirements
applicable to the goods and having effect by virtue of an
order made under section 15 of the Act.
(2) Where, before an official analyst has completed all the examinations,
tests and analyses of a sample of goods that, but for this sub-regulation,
would be necessary for the purpose of paragraph (a) of the last preceding
sub-regulation, the examinations, tests and analyses of the sample carried out
by him show that the goods do not conform to a particular standard, being a
standard applicable to the goods, the last preceding sub-regulation does not
require the official analyst to carry out any further examinations, tests or
analyses of the sample.
THERAPEUTIC GOODS REGULATIONS - REG 12
Certificate of official analyst
12. (1) An official analyst who carries out examinations, tests and analyses
of a sample or part of a sample of goods that has been forwarded to him by an
authorized person -
(a) shall forward to the authorized person a certificate, signed by
him, setting out the results of the examinations, tests and
analyses;
(b) shall forward a copy of the certificate, being a copy signed by
him, to the person from whom the sample was taken; and
(c) if required by the Director-General to do so, shall also forward a
copy of the certificate, being a copy so signed, to the
Director-General.
(2) Subject to the next succeeding sub-regulation, where an official analyst
forwards a copy of a certificate relating to goods as required by the last
preceding sub-regulation and the name and address of -
(a) if the goods were imported into Australia - the importer of the
goods; or
(b) in any other case - the manufacturer of the goods,
is known to the official analyst, the official analyst shall forward a copy of
the certificate, being a copy signed by him, to the importer or manufacturer,
as the case may be, of the goods.
(3) The last preceding sub-regulation does not apply if the person from whom
the sample of the goods was taken was -
(a) in the case of goods imported into Australia - the importer of the
goods; or
(b) in the case of any other goods - the manufacturer of the goods.
(4) Subject to sub-regulation (7) of regulation 13 of these Regulations, in
any legal proceedings under the Act or the Customs Act 1901-1968, a
certificate of an official analyst issued under sub-regulation (1) of this
regulation or a copy of such a certificate, being a copy signed by an official
analyst, is evidence of the facts stated in it.
(5) A document purporting to be -
(a) a certificate of an official analyst issued under sub-regulation (1)
of this regulation; or
(b) a copy of such a certificate,
and to be signed by an official analyst shall, unless the contrary is proved,
be deemed to be such a certificate, or a copy of such a certificate, as the
case may be, and, unless the contrary is proved, the certificate, or the
certificate of which the document purports to be a copy, shall be deemed to
have been duly issued.
THERAPEUTIC GOODS REGULATIONS - REG 13
Review of examination, &c., of official analyst
13. (1) Where a sample of goods to which section 24 of the Act applies, or a
part of such a sample, has been examined, tested and analysed by an official
analyst in accordance with this Part and the official analyst has stated in a
certificate issued under sub-regulation (1) of the last preceding regulation
that the goods do not conform to a specified standard, being a standard
applicable to the goods, a prescribed person may, not later than twenty-one
days after receipt of a copy of the certificate, submit to the
Director-General evidence in writing that the goods do conform to that
specified standard and request that the result of the examination, testing and
analysing be reviewed.
(2) In the application of the last preceding sub-regulation to goods -
(a) the person from whom a sample of the goods was taken; and
(b) if that person is not the importer or manufacturer of the goods -
(i) in the case of goods that were imported into Australia -
the importer of the goods; or
(ii) in any other case - the manufacturer of the goods,
are each a prescribed person.
(3) Where a sample of goods has been divided into three parts, a person
shall be deemed not to have submitted to the Director-General evidence that
the goods conform to a particular standard unless he has submitted to the
Director-General a certificate, under the hand of a duly qualified analyst,
certifying -
(a) that the analyst has examined, tested and analysed a part of the
sample of those goods;
(b) the result of that examination, testing and analysing; and
(c) whether the examination, testing and analysing was carried out
in accordance with any relevant tests.
(4) Where -
(a) after a certificate under sub-section (1) of the last preceding
regulation has been issued stating that specified goods do not
conform to a specified standard, evidence that the goods do
conform
to that standard is duly submitted to the Director-General
under sub-regulation (1) of this regulation; and
(b) that evidence, being, in the case of goods in respect of which a
sample was divided into three parts, the certificate in accordance
with the last preceding sub-regulation that was submitted to the
Director-General with respect to the goods, shows that any
examination, testing and analysing of the goods for the purpose
of establishing that the goods conform to the standard were
carried
out in accordance with any relevant tests,
the next succeeding sub-regulation applies to the goods.
(5) Where this sub-regulation applies to goods, the Director-General shall,
unless the results of the testing of a sample of the goods shows a lack of
homogeneity in the sample, direct -
(a) if the sample of the goods had been divided into three parts - the
authorized person who took the sample to forward the part of the
sample that he had retained; or
(b) if the sample was not divided into three parts but part of the
sample remains unimpaired - the official analyst to forward so
much of the sample as remains unimpaired,
to an analyst agreed upon by the person who requested the review and the
official analyst, or, in the absence of agreement, to an analyst nominated by
the Director-General.
(6) Where part of a sample is forwarded to an analyst in accordance with the
last preceding sub-regulation, the analyst shall -
(a) examine, test and analyse the part of the sample of the goods in
accordance with any relevant tests;
(b) forward to the person from whom the sample was taken a
certificate,
signed by the analyst, setting out the results of the
examinations,
tests and analyses; and
(c) forward copies of that certificate, being copies signed by the
analyst -
(i) to the Director-General; and
(ii) if the person from whom the sample was taken was not
the person who submitted evidence to the Director-General
in relation to the goods - to the person who so
submitted evidence.
(7) A certificate stating the results of the examination, testing and
analysing of a sample or part of a sample of goods issued by the official
analyst under the last preceding regulation ceases to have effect upon the
forwarding of a certificate in relation to those goods by an analyst under the
last preceding sub-regulation.
(8) In any legal proceedings under the Act or the Customs Act 1901-1968, a
certificate of an analyst issued under sub-regulation (6) of this regulation
or a copy of such a certificate, being a copy signed by the analyst, is
evidence of the facts stated in it.
(9) A document purporting to be -
(a) a certificate of an analyst issued under sub-regulation (6) of this
regulation; or
(b) a copy of such a certificate,
and to be signed by an analyst shall, unless the contrary is proved, be deemed
to be such a certificate, or a copy of such a certificate, as the case may be,
and, unless the contrary is proved, the certificate, or the certificate of
which the document purports to be a copy, shall be deemed to have been duly
issued.
THERAPEUTIC GOODS REGULATIONS - REG 14
Relevant tests of goods
14. (1) In this Part, a reference to any relevant test in relation to the
examination, testing and analysing of goods shall be read as a reference to
any test that is, by virtue of a succeeding sub-regulation of this regulation,
a relevant test for the purpose of determining whether goods of a class in
which those goods are included are of a particular standard.
(2) Where the Minister has, by order under section 14 of the Act, specified
a test in accordance with which a matter relating to a standard for a
substance or article is to be determined, that test is a relevant test, in
relation to the examination, testing and analysing of goods that consist, or
are represented to consist, of the substance or article, for the purpose of
determining whether the goods are of that standard.
(3) Where goods are for human use, the goods are the subject of a monograph
on the British Pharmacopoeia and a test for determining a matter relating to a
standard for a substance or article of which the goods consist, or are
represented to consist, is also set out in the monograph, the test so set out
is a relevant test for the purpose of determining whether the goods are of
that standard unless there is a relevant test for that purpose by virtue of
the last preceding sub-regulation.
(4) Where goods are for human use, the goods are the subject of a monograph
in the British Pharmaceutical Codex and a test for determining a matter
relating to a standard for a substance or article of which the goods consist,
or are represented to consist, is also set out in the monograph, the test so
set out is a relevant test for the purpose of determining whether the goods
are of that standard unless there is a relevant test for that purpose by
virtue of either of the last two preceding sub-regulations.
(5) Where goods are for veterinary use, the goods are the subject of a
monograph in the British Veterinary Codex and a test for determining a matter
relating to a standard for a substance or article of which the goods consist,
or are represented to consist, is set out in the monograph, the test so set
out is a relevant test for the purpose of determining whether the goods are of
that standard unless there is a relevant test for that purpose by virtue of
sub-regulation (2) of this regulation.
THERAPEUTIC GOODS REGULATIONS - REG 15
Payment for samples
15. (1) Where a sample of goods to which section 24 of the Act applies is
taken by an authorized person, payment for the quantity of goods taken as the
sample shall be made by the Commonwealth to the person from whom the sample
was taken or, where that person was not the owner of the sample, to the owner,
at the current market value for which that person or the owner, as the case
may be, could have supplied or sold the goods taken as the sample in the
normal course of his business at the time the sample was taken.
(2) The last preceding sub-regulation does not apply to a sample of goods if
there is, for the purposes of the Act, a standard applicable to those goods
and the sample does not conform to that standard.
THERAPEUTIC GOODS REGULATIONS - REG 16
Offences
16. (1) A person shall not -
(a) make or present to the Minister or to a person performing a
function
or exercising a power under these Regulations a statement or
document that is false or misleading in a material particular;
(b) molest, obstruct or endeavour to intimidate or influence an
authorized person in the execution of his powers or the
performance
of his duties under these Regulations; or
(c) upon the request of an authorized person, refuse or omit -
(i) to show the authorized person the place at which any
goods for therapeutic use are kept;
(ii) to admit the authorized person into a place at which
goods for therapeutic use are kept;
(iii) to show the authorized person, or permit the authorized
person to inspect, any goods for therapeutic use kept by
the person;
(iv) to give a sample of goods for therapeutic use;
(v) to answer any inquiry made by the authorized person; or
(vi) to assist the authorized person in the execution of his
powers or the performance of his duties under these
Regulations.
Penalty: Two hundred dollars or imprisonment for six months.
(2) A person is not excused from furnishing information in response to an
inquiry by an authorized person on the ground that the information might tend
to incriminate him, but his furnishing of any information in response to the
inquiry is not admissible in evidence against him in any criminal proceedings,
other than proceedings under the Act or these Regulations.
THERAPEUTIC GOODS REGULATIONS - PART III
PART III - COMMITTEES
THERAPEUTIC GOODS REGULATIONS - REG 17
Therapeutic Goods Advisory Committee
Amended by 1974 No. 166 r. 2; 1975 No. 36; 1979 No. 135 r. 1
17. (1) There shall be a Committee to be known as the Therapeutic Goods
Advisory Committee.
(2) The Committee shall consist of -
(a) the Director-General;
(b) the person for the time being holding the position, or performing
the duties, of the Director of the National Biological Standards
Laboratory;
(c) an officer of the Department of Health, appointed by the
Minister,
not being the officer referred to in the last preceding
paragraph;
(d) a person appointed by the Minister on the nomination of the
Federal
Council of the Australian Medical Association;
(e) a person appointed by the Minister on the nomination of the
Council of the Australian Veterinary Association;
(f) a person appointed by the Minister on the nomination of the
Pharmacy Guild of Australia;
(g) three persons appointed by the Minister on the nomination of the
National Council of Chemical and Pharmaceutical Industries;
(h) a person appointed by the Minister on the nomination of The
Society
of Hospital Pharmacists of Australia; and
(i) a person appointed by the Minister on the nomination of The
Australian Federation of Consumer Organizations Incorporated.
(3) Subject to the next succeeding sub-regulation, the functions of the
Committee are to consider -
(a) any matter referred to it by the Minister relating to the
administration
of the Act; and
(b) the standards applicable to any goods for therapeutic use, and
the requirements with respect to labelling and packaging
applicable
to any such goods, in so far as those standards or
requirements
relate to the manufacture, distribution or use of goods for
therapeutic use.
and to advise the Minister in relation to that matter or those standards.
(4) The Committee is not empowered to consider any matters relating to, or
arising out of the operation of, section 29 of the Act.
Added by 1979 No. 135 r. 1
(5) If the Minister becomes aware that a member of the Committee appointed
by him on the nomination of a body referred to in paragraph
(2)(d),(e),(f),(g),(h) or (i) will be unable to attend a meeting or meetings
of the Committee, the Minister may appoint another person nominated by the
body that nominated the member, to act instead of that member at the meeting
or meetings from which he will be absent, and the person so appointed shall,
while so acting, be deemed to be a member of the Committee.
THERAPEUTIC GOODS REGULATIONS - REG 18
Therapeutic Goods Standards Committee
Amended by 1974 No. 166 r. 3; 1979 No. 135 r. 2
18. (1) There shall be a Committee to be known as the Therapeutic Goods
Standards Committee.
(2) The Committee shall consist of -
(a) the Director-General;
(b) the person for the time being holding the position, or performing
the duties, of the Director of the National Biological Standards
Laboratory;
(c) an analyst appointed by the Minister on the nomination of the
Secretary to the Department of Science;
(d) a person appointed by the Minister on the nomination of the
Pharmaceutical Society of Australia; and
(e) seven other persons appointed by the Minister in accordance with
the succeeding provisions of this regulation.
(3) Subject to the next succeeding sub-regulation, the persons whom the
Minister appoints in pursuance of paragraph (e) of the last preceding
sub-regulation shall be expert in one or more of the fields of human
therapeutics, veterinary therapeutics, pharmacy, pharmaceutics, pharmacology,
bacteriology, pathology, epidemiology, virology, endocrinology, antibiotics,
chemistry, biophysics or biometrics.
(4) The persons to be appointed by the Minister in pursuance of paragraph
(e) of sub-regulation (2) of this regulation shall include -
(a) at least one person who is an expert in pharmacy;
(b) at least one person who is an expert in medicine; and
(c) at least one person who is an expert in veterinary science.
(5) The functions of the Committee are to inquire into the standards and
matters relating to the standards applicable to any goods for therapeutic use
and the requirements with respect to labelling and packaging applicable to any
such goods and to furnish advice to the Minister in relation to those
standards or those requirements.
Amended by 1974 No. 166 r. 3; 1979 No. 135 r. 2
(6) If the Minister becomes aware that a member of the Committee appointed
by him will be unable to attend a meeting or meetings of the Committee, the
Minister may -
(a) in the case of the member appointed on the nomination of the
Pharmaceutical Society of Australia appoint another person
nominated by that Society; or
(b) in the case of a person appointed in pursuance of paragraph (e)
of sub-regulation (2) of this regulation - appoint a person who is
an expert in the same field as the member or, if such a person is
not available, a person who is an expert in one or more of the
other fields specified in sub-regulation (3) of this regulation,
to act instead of that member at the meeting or meetings from which he will be
absent, and the person so appointed shall, while so acting, be deemed to be a
member of the Committee.
(7) The Committee may appoint a sub-committee consisting of such members of
the Committee and such other persons, if any, as the Committee thinks fit for
the purpose of inquiring into, and reporting to the Committee on, any matter
that is within the functions of the Committee.
THERAPEUTIC GOODS REGULATIONS - REG 19
Australian Drug Evaluation Committee
19. (1) There shall be a Committee to be known as the Australian Drug
Evaluation Committee.
(2) The Committee shall consist of not less than six and not more than eight
members, who shall be appointed by the Minister.
(3) The Minister shall, in appointing members of the Committee, ensure that
the members include -
(a) not less than four persons each of whom is a medical practitioner
eminent in his profession and of whom at least three are
specialists
in clinical medicine; and
(b) not less than two persons, each of whom is a pharmacologist or a
person who has been admitted to a degree in science or a branch
of science by an Australian university or an overseas university
and has specialized in pharmaceutical science.
(4) The Minister shall appoint one of the members of the Committee to be
chairman of the Committee.
(5) The functions of the Committee are -
(a) to make medical and scientific evaluations of such goods for
therapeutic use as the Minister refers to it for evaluation;
(b) to make medical and scientific evaluations of other goods for
therapeutic use if, in the opinion of the Committee, it is desirable
that it should do so; and
(c) to furnish such advice to the Minister as the Committee considers
necessary relating to the importation into, and the distribution
within, Australia of goods for therapeutic use that have been the
subject of evaluations made by the Committee.
(6) The Committee may appoint a sub-committee, consisting of such members of
the Committee, and such other persons, if any, as the Committee thinks fit,
for the purpose of enquiring into, and reporting to the Committee on, any
matter that is within the functions of the Committee.
THERAPEUTIC GOODS REGULATIONS - REG 20
Minister may seek further advice
20. Where a Committee established under this Part has furnished advice to
the Minister, the Minister may, if he considers it desirable in the
circumstances to do so, forward a copy of that advice to another Committee
established under this Part and that Committee may furnish the Minister with
such comments in relation to that advice as the Committee thinks fit.
THERAPEUTIC GOODS REGULATIONS - REG 21
Chairman of Committees
21. (1) Subject to this regulation, the Director-General is the chairman of
any Committee established under this Part of which he is a member.
(2) The Director-General may, from time to time, by writing under his hand,
appoint an officer of the Department of Health to act as a member of a
Committee in his stead, and the officer so appointed shall, until his
appointment is revoked, be a member and the chairman of the Committee in the
place of the Director-General.
(3) In this regulation, "Committee" does not include the Australian Drug
Evaluation Committee.
THERAPEUTIC GOODS REGULATIONS - REG 22
Tenure of office of members
22. (1) A member of a Committee established under this Part who is appointed
by the Minister holds office for three years unless he is removed from office
before the expiration of that period under sub-regulation (3) of this
regulation.
(2) A member is eligible for re-appointment.
(3) The Minister may, by writing under his hand, remove a member from office
at any time.
THERAPEUTIC GOODS REGULATIONS - REG 23
Meetings of Committees
23. (1) Meetings of a Committee established under this Part shall be held at
such times and places as the chairman of the Committee directs.
(2) At a meeting of a Committee -
(a) in the case of the Australian Drug Evaluation Committee -
(i) if less than seven members of the Committee are in
Australia when a meeting is held - three members
constitute
a quorum; or
(ii) in any other case - four members constitute a quorum; or
(b) in the case of any other Committee - five members constitute a
quorum.
(3) The chairman of a Committee shall preside at all meetings of the
Committee at which he is present.
(4) In the absence of the chairman of a Committee from a meeting of the
Committee, the members of the Committee present at the meeting shall appoint
one of their number to preside at that meeting, and the member so appointed
has and may exercise and perform at that meeting all the powers and functions
of the chairman.
(5) A question arising at a meeting of a Committee shall be determined by a
majority of votes of the members present and voting on the question.
(6) The chairman or other member presiding at a meeting of a Committee has a
deliberative vote and, in the event of an equality of votes, also has a
casting vote.
THERAPEUTIC GOODS REGULATIONS - REG 24
Powers and functions of Committee where vacancy occurs
24. The exercise and performance of the powers and functions of a Committee
established under this Part is not affected by reason only of there being a
vacancy in the office of a member of that Committee.
THERAPEUTIC GOODS REGULATIONS - REG 25
Remuneration and allowances of members of Committees
25. (1) This regulation does not apply to a member of a Committee
established under this Part who is an officer of the Public Service of the
Commonwealth or of a State.
(2) Subject to the next succeeding sub-regulation, the remuneration payable
to a member of a Committee is -
(a) if the member is the Chairman of the Committee - Forty dollars;
or
(b) in any other case - Thirty-five dollars,
for each day on which he attends a meeting of the Committee.
(3) Where the duration of a meeting of a Committee on a day is less than
three hours, the remuneration payable to a member of the Committee in respect
of his attendance at the meeting on that day is -
(a) if the member is the Chairman of the Committee - Twenty-five
dollars; or
(b) in any other case - Twenty dollars.
Amended by 1973 No. 76 r. 1: 1973 No. 225 r. 1
(4) The chairman or a member of a Committee who is necessarily absent from
his home overnight in connexion with his attendance at a meeting of a
Committee shall be paid a travelling allowance -
(a) at a daily rate of Twenty-eight dollars for each complete day
during
which he is so absent; or
(b) at an hourly rate that is one twenty-fourth part of the daily rate
for each hour or part of an hour if the period during which he is so
absent amounts to less than a day or consists of a day or number
of days plus a number of hours.
(5) The payment of travelling allowance under this regulation is in addition
to the cost of transport fares.
(6) The cost of return transport fares actually and necessarily incurred by
a member of a Committee in travelling between his place of residence and the
place where the meeting of the Committee is held shall be borne by the
Commonwealth.
(7) Subject to the next succeeding sub-regulation, this regulation applies
to and in relation to a sub-committee of a Committee established under this
Part as if -
(a) a reference to a member of a Committee were read as a reference
to a member of such a sub-committee;
(b) a reference to a meeting of a Committee were read as a reference
to a meeting of such a sub-committee; and
(c) a reference to the Chairman of a Committee were read as a
reference
to the Chairman of such a sub-committee.
(8) Where a person attends a meeting of a Committee and a meeting of a
sub-committee of the Committee on the same day, this regulation applies to and
in relation to the member as if the second of those meetings that he attended
on that day were a continuation of the first of those meetings that he
attended on that day.
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