EXPLANATORY STATEMENT
Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008
Proclamation
Item 2 of subsection 2(1) of the Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 (the Act) provides that Schedule 1 to the Act commences on a single day to be fixed by Proclamation. Item 2 also provides that if any of the provisions of Schedule 1 do not commence within the period of 6 months beginning on the day the Act receives Royal Assent, they commence on the first day after the end of that period. The Act received Royal Assent on 3 October 2008.
The purpose of the Proclamation is to fix 1 January 2009 as the day on which Schedule 1 to the Act commences.
Schedule 1 to the Act contains amendments to the Therapeutic Goods Act 1989 (the TG Act) and the Therapeutic Goods (Charges) Act 1989 (the TG Charges Act) in relation to the collection and imposition of annual charges, and the implementation of exemptions from a liability to pay annual charges because of low value turnover of therapeutic goods. In addition to other technical and consequential amendments, Schedule 1 makes it clear that annual charges can be set at nil amounts.
No consultation with industry was undertaken in relation to the measures set out in the Act in view of the low impact of the amendments on business. Some of these changes have already been implemented administratively, such as setting the date of payment of annual charges for goods already entered in the Australian Register of Therapeutic Goods as 1 October of the relevant financial year, and therefore would not affect stakeholders adversely. Stakeholder consultations held from 24 July 2008 to 6 August 2008 outlining the Government plans for reform in therapeutic goods regulations included discussions in relation to the low volume low value exemptions from the payment of annual charges as set out in the Act. The outcomes of these consultations have been published on the Therapeutic Goods Administration’s website (www.tga.gov.au).
A notice was placed on the TGA’s website on 31 October 2008 outlining the effects of the provisions in Schedule 1 of the Act, noting the Proclamation date of 1 January 2009 and explaining that while the provisions in Schedule 1 will commence on the day fixed by Proclamation, some of those provisions introduce changes that will only apply to annual charges payable for the 2009-10 financial year.
The Proclamation is a legislative instrument for the purposed of the Legislative Instruments Act 2003.
The Minute recommends that the Proclamation be made in the form proposed.
Overview
The Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008, enacted by the Parliament of Australia, was introduced to address the need for adjustments in the annual charges related to the collection and imposition of fees for therapeutic goods, as well as the implementation of exemptions for low-value turnover of such goods. The objective of this Act, as outlined in the explanatory statement, is to amend the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989. The Act also clarifies that annual charges can be set at nil amounts. The Act received Royal Assent on 3 October 2008, and a Proclamation was issued to set 1 January 2009 as the commencement date for Schedule 1 of the Act. The low impact of these amendments on businesses meant that no consultation with industry was undertaken, and some changes had already been implemented administratively.
Scope and Application
The Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 applies to entities and persons involved in the manufacture, supply, or importation of therapeutic goods in Australia. It pertains to the amendments in the collection and imposition of annual charges, as well as the implementation of exemptions from these charges due to low-value turnover, as set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989. The Act is a Commonwealth legislation, meaning its jurisdiction covers the entire nation. The Act's provisions commence on 1 January 2009, as fixed by the Proclamation, although some provisions will only apply from the 2009-10 financial year. The Act includes technical and consequential amendments, such as clarifying that annual charges can be set at nil amounts. The scope of the Act is primarily to streamline the financial obligations for businesses dealing with therapeutic goods in Australia.
Key Provisions
The Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 (the Act) is a significant piece of legislation that amends the Therapeutic Goods Act 1989 (TG Act) and the Therapeutic Goods (Charges) Act 1989 (TG Charges Act). The Act introduces amendments primarily concerning the collection and imposition of annual charges for therapeutic goods and the implementation of exemptions for low-value turnover. According to the Explanatory Statement, Schedule 1 of the Act, which contains these amendments, commences on 1 January 2009 as fixed by Proclamation (Section 2(1)). The Act ensures that annual charges can be set at nil amounts, which provides flexibility in the regulatory framework.
Under the Act, entities involved in the supply of therapeutic goods are subject to specific obligations. These include adhering to the new regime for annual charges, which may be adjusted based on the value of goods supplied. For instance, entities with low-value turnover may be exempt from paying annual charges, provided they meet the criteria outlined in the Act (Schedule 1). The Act also mandates that annual charges for goods already entered in the Australian Register of Therapeutic Goods should be paid by 1 October of the relevant financial year. This requirement ensures a consistent and predictable payment schedule, facilitating better compliance and administrative management.
Failure to comply with the provisions of the Act can result in various consequences. While the Explanatory Statement does not specify detailed penalties, breaches of the Act could potentially lead to enforcement actions under the TG Act and TG Charges Act. These may include fines or other administrative penalties as prescribed by the relevant Acts. Additionally, continued non-compliance could affect an entity's standing and eligibility to supply therapeutic goods in Australia, thereby impacting their business operations. The exact nature and extent of penalties are subject to the provisions of the TG Act and TG Charges Act, which provide a comprehensive framework for enforcement and compliance.