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This is a Bill, not an Act. For current law, see the Acts databases.
1998-1999-2000
The Parliament
of the
Commonwealth of
Australia
THE
SENATE
Presented and read a first
time
Therapeutic
Goods Amendment Bill (No. 4) 2000
No.
, 2000
(Health and Aged
Care)
A Bill for an Act to amend the
Therapeutic Goods Act 1989, and for related purposes
ISBN: 0642 463735
Contents
Therapeutic Goods Act
1989 3
A Bill for an Act to amend the Therapeutic Goods Act
1989, and for related purposes
The Parliament of Australia enacts:
This Act may be cited as the Therapeutic Goods Amendment Act
(No. 4) 2000.
(1) Subject to subsection (2), this Act commences on a day to be
fixed by Proclamation.
(2) If this Act does not commence under subsection (1) within the
period of 6 months beginning on the day on which it receives the Royal Assent,
it commences on the first day after the end of that period.
Each Act that is specified in a Schedule to this Act is amended or
repealed as set out in the applicable items in the Schedule concerned, and any
other item in a Schedule to this Act has effect according to its
terms.
1 Subsection 3(1)
Insert:
export only medicine means a medicine that:
(a) is manufactured in Australia for export only, or imported into
Australia for export only; and
(b) is listable goods only because it is so manufactured or imported (and
not for any other reason).
2 Subsection 3(1)
Insert:
listable goods means therapeutic goods that are
required:
(a) under the regulations; or
(b) by a notice published in the Gazette under subsection
17(5);
to be included in the part of the Register relating to listed
goods.
3 Subsection 3(1)
Insert:
working day, for a person, means any day except:
(a) Saturday or Sunday; or
(b) a day that is a public holiday in the State or Territory in which the
person is located.
4 Subsection 16(1)
After “therapeutic goods” (first occurring), insert
“(other than medicine of the kind to which subsection (1A)
applies)”.
5 After subsection 16(1)
Insert:
(1A) Medicines that are listable goods (other than export only medicines)
are taken to be separate and distinct from other therapeutic goods if the
medicines have:
(a) different active ingredients; or
(b) different quantities of active ingredients; or
(c) a different dosage form; or
(d) such other different characteristics as the regulations
prescribe;
from the therapeutic goods.
6 After subsection 22(2)
Insert:
(2A) A person must not, in or in connection with a certification of any
matter under subsection 26A(2), intentionally or recklessly make a statement
that is false or misleading in a material particular.
Maximum penalty: 400 penalty units.
7 Paragraph 26(1)(j)
Repeal the paragraph, substitute:
(j) if the goods have been manufactured in Australia, or imported into
Australia, solely for export—a relevant authority of the country to which
the goods are to be exported has not confirmed its willingness to accept the
goods and:
(i) the goods have been refused registration or listing for supply in
Australia; or
(ii) the Secretary requires such a confirmation for a reason other than
because the goods have been refused registration or listing; or
8 Paragraph 26A(1)(a)
Omit “therapeutic goods”, substitute
“medicine”.
Note: The heading to section 26A is replaced by the
heading “Listing of certain medicines”.
9 Paragraph 26A(1)(b)
Repeal the paragraph.
10 Paragraph 26A(1)(d)
Repeal the paragraph, substitute:
(d) the medicine is not export only medicine;
11 Subsection 26A(1)
Omit “is not to refuse to list the goods”, substitute
“must list the medicine”.
12 Subsection 26A(2)
Repeal the subsection, substitute:
(2) The applicant must certify that:
(a) the medicine is eligible for listing; and
(b) the medicine is safe for the purposes for which it is to be used;
and
(c) the presentation of the medicine is not unacceptable; and
(d) the medicine conforms to every standard (if any) applicable to the
medicine and to every requirement (if any) relating to advertising applicable
under the regulations; and
(e) if the medicine has been manufactured in Australia—each step in
the manufacture of the medicine has been carried out by a person who is the
holder of a licence to carry out that step granted under section 38;
and
(f) the medicine complies with all prescribed quality or safety criteria;
and
(g) the medicine does not contain substances that are prohibited imports
for the purposes of the Customs Act 1901; and
(h) all the manufacturers of the medicine are nominated as manufacturers
in the application; and
(i) the applicant has, with manufacturers of the medicine who are
manufacturers of the prescribed kind, written agreements containing such matters
as are prescribed; and
(j) the applicant holds information or evidence to support any claim that
the applicant makes relating to the medicine; and
(k) the information included in or with the application is
correct.
13 Subsection 26A(3)
Omit “goods”, substitute “medicine”.
14 Subparagraph
26A(4)(a)(i)
Omit “the goods are not therapeutic devices and”.
15 Subparagraph
26A(4)(a)(i)
Omit “goods” (second and third occurring), substitute
“medicine”.
16 Subparagraph
26A(4)(a)(ii)
Omit “goods”, substitute “medicine”.
17 Paragraph 26A(4)(b)
Omit “goods”, substitute “medicine”.
18 At the end of subsection
26A(4)
Add:
; and (c) whether the applicant has complied with any requirements made by
the Secretary under section 31 in relation to the manufacture or
preparation of the medicine.
19 Subsection 26A(5)
Omit “therapeutic goods are”, substitute “a medicine
is”.
20 Subsection 26A(5)
Omit “goods” (second and third occurring), substitute
“medicine”.
21 Subsection 26A(6)
Omit “therapeutic goods”, substitute “a
medicine”.
22 Subsection 26A(6)
Omit “goods” (second and third occurring), substitute
“medicine”.
23 Paragraph 26A(7)(a)
Omit “therapeutic goods were”, substitute “a medicine
was”.
24 Paragraph 26A(7)(b)
Omit “goods been made in Australia, they”, substitute
“medicine been made in Australia, it”.
25 Subsection 26A(7)
Omit “goods” (third occurring), substitute
“medicine”.
26 Subsection 26A(8)
Repeal the subsection.
27 Subsection 26A(9)
Omit “an applicant has been informed that therapeutic goods in
respect of which an application was made are acceptable for listing”,
substitute “a medicine has been listed under this
section”.
28 Subsection 26A(9)
Omit “the goods” (wherever occurring), substitute “the
medicine”.
29 After subsection 28(5)
Insert:
(5A) In addition to any conditions imposed under subsection (1), (3)
or (5), the listing of a medicine under section 26A is subject to a
condition that the person in relation to whom the medicine is listed will
deliver a reasonable number of samples of the medicine if the Secretary so
requests:
(a) within the period specified in the request; and
(b) in accordance with any other requirements specified in the
request.
The period specified in the request must include at least 10 working
days.
30 Paragraph 30(1)(e)
Omit “goods”, substitute “a medicine”.
31 After subsection 30(1)
Insert:
(1A) The Secretary may, by notice in writing given to a person in relation
to whom a medicine is listed under section 26A, cancel the listing of the
medicine if:
(a) the medicine is not eligible for listing; or
(b) the medicine is exempt; or
(c) there is a serious breach, involving the medicine, of the requirements
relating to advertising applicable under the regulations, and the Secretary is
satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of the medicine is
misleading to a significant extent.
(1B) However, paragraph (1A)(c) does not apply to medicines that are
manufactured in Australia for export only, or are imported into Australia for
export only.
(1C) The Secretary may, by notice in writing given to a person in relation
to whom a medicine is listed under section 26A, cancel the listing of the
medicine if:
(a) the Secretary, under section 31, gives to the person a notice
requiring the person to give to the Secretary information or documents relating
to the medicine; and
(b) the notice is given for the purposes of ascertaining whether the
medicine should have been listed; and
(c) the person fails to comply with the notice within 20 working days
after the notice is given.
32 Paragraph 30(2)(ba)
Omit “goods”, substitute “a medicine”.
33 Paragraph 30(2)(ba)
Omit “or (h)”, substitute “, (h), (i), (j) or
(k)”.
34 Subsection 30(5)
Omit “subsection (1)”, substitute
“subsection (1), (1A) or (1C)”.
35 At the end of
section 31
Add:
(6) A person in relation to whom a medicine is listed under
section 26A must not, in purported compliance with a notice under this
section relating to the medicine, intentionally or recklessly provide
information that is false or misleading in a material particular.
Maximum penalty: 400 penalty units.
36 Application of
amendments
(1) The amendments made by this Schedule do not apply, and the
Therapeutic Goods Act 1989 as in force immediately before the
commencement of this Schedule continues to apply, in relation to any application
made under that Act, before that commencement, for listing of therapeutic
goods.
(2) However, the amendment made by item 5 of this Schedule applies,
after that commencement, to therapeutic goods that were listed before that
commencement.
(3) The amendment made by item 31 of this Schedule applies, after that
commencement, to medicines listed under section 26A before that
commencement.