Commonwealth Numbered Acts

THERAPEUTIC GOODS AMENDMENT ACT 1997 No. 116 of 1997 - SCHEDULE 1

Schedule 1-Amendment of the Therapeutic Goods Act 1989
Part 1-Therapeutic goods not conforming to standards 1 At the end of Division
2 of Part 3
Add: 30B Recovery etc. of registered or listed goods not conforming to
standards

(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: 3A Declaration-member of European Community

(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: 25A Registration of therapeutic device to which conformity assessment
certificate applies

(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: 26AA Listing of therapeutic device to which conformity assessment
certificate applies

(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)".
Part 3-Other amendments 15 Paragraph 26A(2)(c)
Omit "acceptable", substitute "not unacceptable".

[Minister's second reading speech made in-
Senate on 26 March 1997
House of Representatives on 25 June 1997]