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1999
THE PARLIAMENT OF THE COMMONWEALTH OF
AUSTRALIA
HOUSE OF
REPRESENTATIVES
THERAPEUTIC GOODS
AMENDMENT BILL 1999
EXPLANATORY
MEMORANDUM
(Circulated by authority of the
Parliamentary Secretary to the Minister for
Health and Aged Care, Senator
Grant Tambling)
ISBN: 0642 42487X
Therapeutic Goods Amendment Bill
1999
OUTLINE
Schedule 1 of this Bill proposes amendments to
the Therapeutic Goods Act 1989, as listed in Items 1 to 11
inclusive.
The effect of the changes made under these Items will
be to:
• implement the Agreement on Mutual Recognition in relation
to Conformity Assessment, Certificates and Markings between Australia and the
European Free Trade Association (EFTA-MRA). The Agreement will extend the
regime of the European Union Mutual Recognition Agreement (EU-MRA) to
incorporate the three EFTA countries (Norway, Liechtenstein and Iceland). This
will enable Conformity Assessment Bodies, designated by the Designating
Authorities of member states of the European Community and the European Free
Trade Association, to evaluate or assess therapeutic devices exported to
Australia from the EC and EFTA to establish compliance with Australia regulatory
requirements under the Act. If satisfied that therapeutic devices meet with
Australian regulatory requirements, the Body may issue Conformity Assessment
Certificates, which will enable the products to be marketed in Australia without
further assessment under the Act upon import, unless the Secretary is satisfied
that supply of the goods in Australia may compromise the health or safety of
users;
FINANCIAL IMPACT STATEMENT
The amendments to the Act outlined
above have no significant financial impact.
NOTES ON CLAUSES
Clause 1 - This clause states that the short title of the Act will
be the Therapeutic Goods Amendment Act 1999.
Clause 2 -
This clause states that the Act will commence on the day it receives the Royal
Assent.
Clause 3 states that when the amendments commence to
operate, they will amend the Act as described in each of the items listed in the
Schedule to the Act.
SCHEDULE 1 - AMENDMENTS TO THE THERAPEUTIC
GOODS ACT 1989
Items 1 to 6 insert or amend definitions under
subsection 3(1) of the Act relating to the EC Mutual Recognition Agreement and
the EFTA Mutual Recognition Agreement.
Item 1 provides that in the
definition of conformity assessment body, "Mutual Recognition
Agreement" is omitted and replaced with "EC Mutual Recognition Agreement or the
EFTA Mutual Recognition Agreement".
Item 2 provides that in the
definition of conformity assessment certificate, "Mutual
Recognition Agreement" is omitted and replaced with "EC Mutual Recognition
Agreement or the EFTA Mutual Recognition Agreement".
Item 3
provides that EC 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.
Item 4 provides that EFTA Mutual Recognition Agreement
means the Agreement on Mutual Recognition in relation to Conformity
Assessment, Certificates and Markings between Australia and the European Free
Trade Association, as in force from time to time.
Item 5 provides
that a member of EFTA means a country declared by the Minister
under section 3A to be a member of the European Free Trade
Association.
Item 6 repeals the definition of Mutual
Recognition Agreement, as this has been replaced with the "EC Mutual
Recognition Agreement" and the EFTA EC Mutual Recognition Agreement".
Item 7 repeals subsection 3A(1) and replaces it with a provision that
will enable the Secretary to declare that a country specified in the written
declaration is a member of the European Community or the European Free Trade
Association.
Items 8 to 10 inclusive are consequential amendments, to
implement the EFTA Mutual Recognition Agreement.
Item 8 amends
subparagraph 25(2)(a)(i) to include a reference to members of EFTA by
providing that, for the purposes of determining whether the manufacturing and
quality control procedures used in any step of manufacture of a registrable
medicinal product carried out overseas is acceptable (for the purposes of
paragraph 25(1)(g) of the Act), the Secretary is to take into account any
conformity assessment certificate that an applicant provides for the applicant's
goods, if a step in the manufacture of the goods has been carried out in a
country that is a member of the EC or a member of EFTA.
Item
9 has the effect of amending subparagraph 26(2)(a)(i) of the Act in the same
way subparagraph 25(2)(a)(i) above has been amended. This item includes a
reference to members of EFTA so that, for the purposes of determining whether
the manufacturing and quality control procedures used in any step of manufacture
of a listable medicinal product carried out overseas is acceptable (for the
purposes of paragraph 26(1)(g) of the Act), the Secretary is to take into
account any conformity assessment certificate that an applicant provides for the
applicant's goods if a step in the manufacture of the goods has been carried out
in a country that is a member of the EC or a member of EFTA.
Item 10 amends subparagraph 26A(4)(a)(i) to include a reference
to members of EFTA so that, for the purposes of deciding whether to certify that
the manufacturing and quality control procedures used in each step of
manufacture of a listable medicinal product carried out overseas is acceptable,
the Secretary may take into account whether the applicant has provided a
conformity assessment certificate in relation to all steps of manufacture of the
goods that was carried out in a country that is a member of the EC or a member
of EFTA.
Item 11 amends subsection 61(1) by omitting "Mutual
Recognition Agreement" and replacing it with "EC Mutual Recognition Agreement or
the EFTA Mutual Recognition Agreement".