A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes
The Parliament of Australia enacts:
1 Short title
This Act may be cited as the Therapeutic Goods Amendment Act (No. 2) 2005.
2 Commencement
(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information |
| Column 1 | Column 2 | Column 3 |
| Provision(s) | Commencement | Date/Details |
| 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table | The day on which this Act receives the Royal Assent. | |
| 2. Schedule 1 | A single day to be fixed by Proclamation. However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period. | |
Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.
(2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act.
3 Schedule(s)
Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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
1 Paragraph 25(4)(d)
Repeal the paragraph, substitute:
(d) if the decision is to register the goods:
(i) notify the applicant in writing that the goods will be included in the Register if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and
(ii) include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application.
2 Subsection 25(4) (second sentence)
Repeal the sentence, substitute:
To avoid doubt, if the applicant gives the Secretary the certificate required under subsection 26B(1) or a notice that a certificate under that subsection is not required in relation to the application, the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate or the notice.
3 At the end of subsection 25(4A)
Add “or a notice given under subparagraph (4)(d)(ii)”.
4 Paragraph 26(1)(aa)
Repeal the paragraph, substitute:
(aa) if goods are not therapeutic devices—the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and
5 Paragraph 26(1A)(b)
Repeal the paragraph, substitute:
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice that a certificate under that subsection is not required in relation to the application; and
6 At the end of subsection 26(1A)
Add “or the notice”.
7 At the end of subsection 26(1B)
Add “or a notice given under subparagraph (1)(aa)(ii)”.
8 Paragraph 26A(1)(b)
Repeal the paragraph, substitute:
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and
9 Paragraph 26A(1A)(b)
Repeal the paragraph, substitute:
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice that a certificate under that subsection is not required in relation to the application; and
10 At the end of subsection 26A(1A)
Add “or the notice”.
11 At the end of subsection 26A(1B)
Add “or a notice given under subparagraph (1)(b)(ii)”.
12 Before subsection 26B(1)
Insert:
(1A) A certificate is required under subsection (1) in relation to an application for registration or listing of therapeutic goods only if:
(a) the applicant is required to submit evidence or information to establish the safety or efficacy of the goods as part of the process of applying for registration or listing; and
(b) in order to satisfy that requirement, the applicant relies (in whole or in part) on evidence or information that another person submitted to the Secretary:
(i) to establish the safety or efficacy of other therapeutic goods that have already been registered or listed; and
(ii) as part of the process of applying for the registration or listing of those other goods.
13 Subsection 26B(1)
Omit “certificate required by”, substitute “certificate required under”.
14 After section 26B
Insert:
26BA Approved form for notices
An approval of a form for a notice for the purposes of subsection 25(4), 26(1) or 26A(1) may require or permit the notice to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
15 Application
The amendments made by this Schedule apply to applications for registration or listing of therapeutic goods that are made on or after the day on which this Schedule commences.