Therapeutic Goods Amendment Act 1997

Therapeutic Goods Amendment Act 1997

No. 116, 1997

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

Contents

1 Short title..................................2

2 Commencement..............................2

3 Schedule(s).................................2

Schedule 1—Amendment of the Therapeutic Goods Act 1989 3

Part 1—Therapeutic goods not conforming to standards 3

Part 2—Amendments relating to the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community              5

Part 3—Other amendments 10

Therapeutic Goods Amendment Act 1997

No. 116, 1997

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

[Assented to 7 July 1997]

The Parliament of Australia enacts:

1  Short title

  This Act may be cited as the Therapeutic Goods Amendment Act 1997.

2  Commencement

 (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.

3  Schedule(s)

  Subject to section 2, each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

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]