Therapeutic Goods (Charges) Amendment Act 2010
No. 53, 2010
An Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes
Contents
1 Short title
2 Commencement
3 Schedule(s)
Schedule 1—Amendments
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Amendment Act 2010
No. 53, 2010
An Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes
[Assented to 31 May 2010]
The Parliament of Australia enacts:
1 Short title
This Act may be cited as the Therapeutic Goods (Charges) Amendment Act 2010.
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 this Act receives the Royal Assent. | 31 May 2010 |
2. Schedule 1 | At the same time as Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 commences. | 31 May 2011 |
Note: This table relates only to the provisions of this Act as originally passed by both Houses of 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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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—Amendments
Therapeutic Goods (Charges) Act 1989
1 After subsection 3(1)
Insert:
(1A) For the purposes of this Act, if a suspension of the registration or listing of therapeutic goods has effect under Part 3‑2 of the Therapeutic Goods Act 1989, the goods are taken to be included in the Register under that Part.
(1B) For the purposes of this Act, if a suspension of a biological from the Register has effect under Part 3‑2A of the Therapeutic Goods Act 1989, the biological is taken to be included in the Register under that Part.
2 Subsection 3(2)
Omit “However, for”, substitute “For”.
3 After subsection 4(1A)
Insert:
(1AA) An annual charge of such amount as is prescribed is payable in respect of the inclusion of a biological in the Register under Part 3‑2A of the Therapeutic Goods Act that has effect at any time during a financial year.
4 After subsection 4(4)
Insert:
(4A) If, because of the operation of section 6AAE of the Therapeutic Goods Act, a biological is included in the part of the Register for biologicals included under Part 3‑2A, this section has effect as if the biological had been included in the Register under Part 3‑2A of that Act.
[Minister’s second reading speech made in—
House of Representatives on 25 November 2009
Senate on 18 March 2010]
Overview
The Therapeutic Goods (Charges) Amendment Act 2010 was enacted by the Parliament of Australia to amend the Therapeutic Goods (Charges) Act 1989. This Act aims to address gaps in the regulatory framework by introducing specific provisions concerning the charges for therapeutic goods, particularly in relation to the inclusion of biologicals in the Register. The policy objective behind this amendment is to ensure a more precise and effective system for charging related to therapeutic goods, thereby supporting the regulatory oversight provided by the Therapeutic Goods Act 1989. The Act came into effect on 31 May 2010, with certain provisions commencing on 31 May 2011, aligning with related legislative changes to maintain consistency in the regulatory environment.
Scope and Application
The Therapeutic Goods (Charges) Amendment Act 2010 is an Australian Commonwealth Act that amends the Therapeutic Goods (Charges) Act 1989. It applies to entities involved in the registration and listing of therapeutic goods, including biologicals, as well as to the entities responsible for paying the associated charges. The Act's scope extends to therapeutic goods that are subject to the Therapeutic Goods Act 1989, and it introduces modifications to the charge structure for these goods. The Act commenced on 31 May 2010, with specific sections coming into effect on that date or on 31 May 2011 as outlined in the commencement table. The legislation introduces changes such as treating suspended registrations or listings as inclusions in the Register for charge purposes, and it mandates an annual charge for biologicals included in the Register under Part 3-2A of the Therapeutic Goods Act 1989. These amendments are designed to ensure that the charging structure aligns with the regulatory framework for therapeutic goods.
Key Provisions
The Therapeutic Goods (Charges) Amendment Act 2010 (C2010A00053) amends the Therapeutic Goods (Charges) Act 1989 by introducing new provisions and modifying existing ones to better regulate the charging system for therapeutic goods. Section 1 of the Act allows it to be cited as the Therapeutic Goods (Charges) Amendment Act 2010. The Act commenced on 31 May 2010 for most provisions and on 31 May 2011 for the Schedule 1 amendments, as per the table in Section 2. Schedule 1 of the Act details the specific amendments to the Therapeutic Goods (Charges) Act 1989.
Under the amendments, Section 1(1A) of the Therapeutic Goods (Charges) Act 1989 is altered to include suspended registrations or listings of therapeutic goods in the Register for charge purposes. Similarly, Section 1(1B) includes suspended biologicals in the Register. These changes ensure that suspended items are still subject to charges, maintaining regulatory oversight and financial accountability. Section 1(2) modifies the language in subsection 3(2) to streamline the text without altering the substantive meaning. The insertion of subsection 3(1AA) mandates an annual charge for biologicals included in the Register under Part 3-2A of the Therapeutic Goods Act 1989, aligning with the regulatory framework for these items. Finally, subsection 4(4A) adjusts the application of section 4 to account for biologicals included under section 6AAE of the Therapeutic Goods Act 1989, ensuring consistency in the treatment of such biologicals.
Entities and individuals governed by the Therapeutic Goods (Charges) Act 1989 are now required to comply with the new provisions regarding the inclusion of suspended therapeutic goods and biologicals in the Register. This means they must account for these items when calculating annual charges. Specifically, they must ensure that any suspended therapeutic goods or biologicals are included in their charge calculations, reflecting the continuous oversight and management of these items. Additionally, the introduction of an annual charge for biologicals listed under Part 3-2A necessitates that registrants and listers of such biologicals budget for and pay these charges annually.
Failure to comply with the new requirements could result in civil or criminal penalties, depending on the nature and severity of the breach. While the specific penalties are not detailed within the Act, general provisions under the Therapeutic Goods Act 1989 could apply, including fines and potential prosecution for serious or repeated breaches. The precise penalties would depend on the relevant provisions of the Therapeutic Goods Act 1989 and any other applicable legislation. The introduction of these amendments underscores the importance of strict adherence to regulatory requirements to maintain the integrity of the therapeutic goods market in Australia.