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This is a Bill, not an Act. For current law, see the Acts databases.
1996-97
The Parliament of
the
Commonwealth of
Australia
THE
SENATE
Presented and read a first
time
Therapeutic Goods
Amendment Bill 1997
No. ,
1997
(Health and Family
Services)
A Bill for an Act to amend the
Therapeutic Goods Act 1989 to make provision relating to the listing of
therapeutic goods and the supply of therapeutic goods not conforming to
standards and to give effect to Australia’s obligations regarding
therapeutic goods under an Agreement on Mutual Recognition with the European
Community
9704820--1,050/21.3.1997--(48/97) Cat. No. 96 7465 9 ISBN 0644
500522
Contents
Part 1—Therapeutic goods not conforming to
standards 7tga00s1.html
Part 2—Amendments relating to the Agreement on Mutual Recognition in
relation to Conformity Assessment, Certificates and Markings between Australia
and the European Community 7tga00s1.html
Part 3—Other amendments 7tga00s1.html
A Bill for an Act to amend the Therapeutic Goods Act
1989 to make provision relating to the listing of therapeutic goods and the
supply of therapeutic goods not conforming to standards and to give effect to
Australia’s obligations regarding therapeutic goods under an Agreement on
Mutual Recognition with the European Community
The Parliament of Australia enacts:
This Act may be cited as the Therapeutic Goods Amendment Act
1997.
(1) Subject to subsection (2), this Act commences on the day on which it
receives the Royal Assent.
(2) Part 2 of Schedule 1 commences on a day to be fixed by Proclamation.
That day must not be earlier than the day on which the Agreement on Mutual
Recognition in relation to Conformity Assessment, Certificates and Markings
between Australia and the European Community enters into force.
(3) If Part 2 of Schedule 1 does not commence under subsection (2)
within the period of 6 months after the day on which the Agreement referred to
in that subsection enters into force, that Part commences on the first day after
the end of that period.
Subject to section 2, 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Act is amended or repealed as set out in the applicable items in the Schedule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.
Part
1—Therapeutic goods not conforming to standards
1 At the end of Division 2 of Part
3
Add:
(1) This section applies if:
(a) therapeutic goods of a particular kind are included in the Register in
relation to a person; and
(b) any person supplies a batch of goods of that kind; and
(c) the Secretary is satisfied that the goods included in that batch do
not conform to a standard applicable to goods of that kind; and
(d) the Secretary is not aware that any other goods of that kind supplied
by the person within the previous 6 months have failed to conform to that
standard or another standard applicable to goods of that kind.
(2) The Secretary may, in writing, impose on the sponsor of the goods one
or both of the following requirements:
(a) to inform the public or a specified class of persons, in the specified
manner and within such reasonable period as is specified, that the goods
included in that batch do not conform to a standard applicable to goods of that
kind;
(b) to take steps to recover the goods included in that batch (except any
of those goods that cannot be recovered because they have been administered to,
or applied in the treatment of, a person or animal).
(3) The Secretary must cause to be published in the Gazette, as
soon as practicable after imposing such a requirement, a notice setting out
particulars of the requirement.
(4) A person who intentionally refuses or fails to comply with a
requirement under subsection (2) is guilty of an offence.
Maximum penalty: 60 penalty units
(5) This section does not prevent the Secretary from taking action under
section 30.
Part
2—Amendments relating to the Agreement on Mutual Recognition in relation
to Conformity Assessment, Certificates and Markings between Australia and the
European Community
2 Subsection 3(1)
Insert:
approved conformity assessment body means a conformity
assessment body approved by the Secretary in writing.
3 Subsection 3(1)
Insert:
conformity assessment body means a Conformity Assessment Body
designated in one of the following Sectoral Annexes to the Mutual Recognition
Agreement:
(a) Sectoral Annex (Medical Devices);
(b) Sectoral Annex (Medicinal Products GMP Inspection and Batch
Certification).
4 Subsection 3(1)
Insert:
conformity assessment certificate means an attestation of
conformity (within the meaning of the Mutual Recognition Agreement) issued by an
approved conformity assessment body.
5 Subsection 3(1)
Insert:
member of the European Community means a country declared by
the Minister under section 3A to be a member of the European
Community.
6 Subsection 3(1)
Insert:
Mutual Recognition Agreement means the
Agreement on Mutual Recognition in relation to Conformity Assessment,
Certificates and Markings between Australia and the European Community, as in
force from time to time.
7 After section 3
Insert:
(1) The Minister may declare, in writing, that a country specified in the
declaration is a member of the European Community.
(2) A declaration under subsection (1) must be published in the
Gazette.
8 Paragraph 25(2)(a)
Repeal the paragraph, substitute:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the manufacture
of the goods has been carried out in a country that is a member of the European
Community—a conformity assessment certificate in relation to the goods;
or
(ii) in any other case—an acceptable form of evidence from a
relevant overseas authority establishing that the manufacture of the goods is of
an acceptable standard; and
9 After section 25
Insert:
(1) If:
(a) an application is made in accordance with section 23 for the
registration of a therapeutic device in relation to a person; and
(b) the applicant gives to the Secretary a conformity assessment
certificate as to the matters that would require evaluation under subsection
25(1) if that subsection applied in relation to the device;
the Secretary must register the device unless the Secretary considers that
the device may compromise the health or safety of users.
(2) The Secretary must notify the applicant in writing of his or her
decision on the application within 28 days of the making of the decision. If the
Secretary decides not to register the device, the notice must contain the
reasons for that decision.
(3) If the Secretary decides to register the device, the Secretary
must:
(a) include the device in the Register; and
(b) give to the applicant a certificate of registration.
(4) The registration of the device commences on the day specified for the
purpose in the certificate of registration.
10 Subsection 26(1)
Before “the Secretary” (second occurring), insert “then,
subject to section 26AA,”.
11 Paragraph 26(2)(a)
Repeal the paragraph, substitute:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the manufacture
of the goods has been carried out in a country that is a member of the European
Community—a conformity assessment certificate in relation to the goods;
or
(ii) in any other case—an acceptable form of evidence from a
relevant overseas authority establishing that the manufacture of the goods is of
an acceptable standard; and
12 After section 26
Insert:
(1) If:
(a) an application is made in accordance with section 23 for the listing
of a therapeutic device in relation to a person; and
(b) the applicant gives to the Secretary a conformity assessment
certificate as to the matters specified in paragraphs 26(1)(c) to (m) in
relation to the device;
the Secretary must list the device in relation to the person unless the
Secretary considers that the device may compromise the health or safety of
users.
(2) The Secretary must notify the applicant in writing of his or her
decision within 28 days of the making of the decision. If the Secretary decides
not to list the device, the notice must contain the reasons for that decision.
(3) If the Secretary decides to list the device, the Secretary
must:
(a) include the device in the Register; and
(b) give to the applicant a certificate of listing.
(4) The listing of the device commences on the day specified for the
purpose in the certificate of listing.
13 Paragraph 26A(4)(a)
Repeal the paragraph, substitute:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the manufacture
of the goods has been carried out in a country that is a member of the European
Community—a conformity assessment certificate in relation to the goods;
or
(ii) in any other case—an acceptable form of evidence from a
relevant overseas authority establishing that the manufacture of the goods is of
an acceptable standard; and
14 Subsection 61(1) (at the end of the
definition of therapeutic goods information)
Add “(including functions relating to the Mutual Recognition
Agreement)”.
15 Paragraph 26A(2)(c)
Omit “acceptable”, substitute “not
unacceptable”.