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Health Legislation Amendment Bill (No. 3) 2001
Schedule 1 Therapeutic Goods

   

Therapeutic Goods Act 1989

1  Subsection 3(1) (definition of approved conformity assessment body )

Repeal the definition.

2  Subsection 3(1) (definition of conformity assessment body )

Repeal the definition.

3  Subsection 3(1) (definition of conformity assessment certificate )

Repeal the definition.

4  Subsection 3(1) (definition of conformity assessment certificate )

Repeal the definition, substitute:

conformity assessment certificate means a certificate issued under section 41EE.

5  Subsection 3(1)

Insert:

EC/EFTA attestation of conformity means an attestation of conformity (within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment body that is approved by the Secretary in writing.

6  Subsection 3(1)

Insert:

EC/EFTA conformity assessment body means a Conformity Assessment Body designated in one of the following Sectoral Annexes to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement:

                     (a)  Sectoral Annex (Medical Devices);

                     (b)  Sectoral Annex (Medicinal Products GMP Inspection and Batch Certification).

7  Subsection 3(1)

Insert:

international instrument means:

                     (a)  any treaty, convention, protocol, agreement or other instrument that is binding in international law; and

                     (b)  a part of such a treaty, convention, protocol, agreement or other instrument.

8  Subsection 3(1)

Insert:

non-EC/EFTA attestation of conformity , for a non-EC/EFTA MRA, means an attestation of conformity issued, after the non-EC/EFTA MRA has come into force, by a conformity assessment body that is designated in the non-EC/EFTA MRA and approved by the Secretary in writing for the non-EC/EFTA MRA.

9  Subsection 3(1)

Insert:

non-EC/EFTA MRA means an international instrument that Australia is bound by, or is a party to, if:

                     (a)  a purpose of the instrument is the recognition of attestations of conformity; and

                     (b)  the instrument satisfies the requirements (if any) set out in regulations made for the purposes of this paragraph;

but does not include:

                     (c)  the EC Mutual Recognition Agreement; or

                     (d)  the EFTA Mutual Recognition Agreement.

10  After section 3A

Insert:

3B   Declaration—country covered by non-EC/EFTA MRA

             (1)  The Minister may declare, in writing, that a country specified in the declaration is covered by the non-EC/EFTA MRA specified in the declaration.

             (2)  A declaration under subsection (1) must be published in the Gazette .

11  At the end of section 24D

Add:

             (6)  Despite subsection (5), if:

                     (a)  the Secretary has given the applicant all evaluation reports relating to the application; and

                     (b)  the Secretary has given those reports, or proposes to give those reports, to a committee established under the regulations to advise the Secretary on applications to register therapeutic goods to which subsection (1) applies; and

                     (c)  the applicant withdraws the application after being given the reports, and before the end of the period mentioned in subsection (1);

the evaluation is taken for the purposes of subsections (2), (3) and (4) to be completed immediately before the time of withdrawal.

12  Subparagraph 25(2)(a)(i)

Repeal the subparagraph, substitute:

                              (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 or a member of EFTA—an EC/EFTA attestation of conformity in relation to the goods; or

                            (ia)  if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country declared by the Minister under section 3B to be covered by a non-EC/EFTA MRA—a non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to the goods; or

13  Paragraph 25B(1)(b)

Omit “a conformity assessment certificate”, substitute “an EC/EFTA attestation of conformity”.

Note:       The heading to section 25B is altered by omitting “ conformity assessment certificate ” and substituting “ EC/EFTA attestation of conformity ”.

14  Subparagraph 26(2)(a)(i)

Repeal the subparagraph, substitute:

                              (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 or a member of EFTA—an EC/EFTA attestation of conformity in relation to the goods; or

                            (ia)  if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country declared by the Minister under section 3B to be covered by a non-EC/EFTA MRA—a non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to the goods; or

15  Paragraph 26AA(1)(b)

Omit “a conformity assessment certificate”, substitute “an EC/EFTA attestation of conformity”.

Note:       The heading to section 26AA is altered by omitting “ conformity assessment certificate ” and substituting “ EC/EFTA attestation of conformity ”.

16  Subparagraph 26A(4)(a)(i)

Repeal the subparagraph, substitute:

                              (i)  if a step in the manufacture of the medicine has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the medicine; or

                            (ia)  if a step in the manufacture of the medicine has been carried out in a country declared by the Minister under section 3B to be covered by a non-EC/EFTA MRA—a non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to the medicine; or

17  After paragraph 37(1)(d)

Insert:

                    (da)  if the applicant proposes to carry out steps in the manufacture of blood or blood components under the licence—contain information relating to those steps set out in regulations made for the purposes of this paragraph; and

18  After paragraph 40(4)(a)

Insert:

                    (aa)  if:

                              (i)  the holder of the licence carries out, or proposes to carry out, steps in the manufacture of blood or blood components under the licence; and

                             (ii)  regulations made for the purposes of this paragraph set out particular information relating to those steps;

                            comply with a request by the Secretary to provide such information, in accordance with those regulations; and

19  Application

(1)        The amendment made by item 11 applies in relation to applications made on or after the commencement of that item.

(2)        The amendment made by item 17 applies in relation to applications for licences made on or after the commencement of that item.

(3)        Paragraph 40(4)(a) of the Therapeutic Goods Act 1989 as amended by this Schedule applies in relation to a request made under that paragraph on or after the commencement of this item, even if the licence to which the request relates was granted before that commencement.

20  Transitional

(1)        An approval of a body as an approved conformity assessment body that was in force under the Therapeutic Goods Act 1989 immediately before the commencement time has effect after the commencement time as if it were an approval of the body by the Secretary in writing for the purposes of the definition of EC/EFTA attestation of conformity in subsection 3(1) of the Therapeutic Goods Act 1989 as in force after the commencement time.

(2)        In subitem (1):

commencement time means the time at which this item commences.

Therapeutic Goods Amendment (Medical Devices) Act 2001

21  Item 7 of Schedule 1

Repeal the item, substitute:

7  Subsection 3(1)

Insert:

conformity assessment certificate means a certificate issued under section 41EE.