Therapeutic Goods (Charges) Amendment Act 1991
No. 85 of 1991
An Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes
[Assented to 26 June 1991]
The Parliament of Australia enacts:
Short title etc.
1. (1) This Act may be cited as the Therapeutic Goods (Charges) Amendment Act 1991.
(2) In this Act, “Principal Act” means the Therapeutic Goods (Charges) Act 19891.
Commencement
2. This Act commences, or is taken to have commenced, as the case requires, on the commencement of Part 5 of the Community Services and Health Legislation Amendment Act 1991.
Charges
3. Section 4 of the Principal Act is amended:
(a) by inserting in subsection (1) “, other than grouped therapeutic goods,” after “goods”;
(b) by inserting after subsection (1) the following subsection:
“(1a) If the registration or listing of one or more grouped therapeutic goods, being goods covered by a single registration or listing number, is in force at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the registrations or listings concerned.”.
Application of amendments
4. The amendments made by this Act apply as follows:
(a) in the case of the financial year in which the date of commencement of this section occurred—to registrations or listings that commenced on or after that date;
(b) in the case of a later financial year—to all registrations or listings.
Transitional
5. (1) In this section:
“amended Act” means the Principal Act as amended by this Act.
(2) For the purposes of the application of the Principal Act to charges:
(a) for the financial year in which the date of commencement of this section occurred or an earlier financial year; and
(b) in respect of registrations or listings:
(i) in force at a particular time before that date; and
(ii) that commenced before that date; if therapeutic goods were treated, at that time, as single therapeutic goods for the purposes of Part 3 of the Therapeutic Goods Act 1989, then those goods are taken to have been treated as single therapeutic goods.
(3) For the purposes of the amended Act, regulations made, or purporting to be made, for the purposes of subsection 4 (1) of the Principal Act, to the extent that the regulations covered goods that were treated as single therapeutic goods for the purposes of Part 3 of the Therapeutic Goods Act 1989, have effect as if the regulations were made for the purposes of subsection 4 (1a) of the amended Act and had covered the corresponding grouped therapeutic goods.
(4) If a charge is payable under subsection 4 (1) of the Principal Act in relation to the financial year in which the date of commencement of this section occurred in respect of the registration or listing of
therapeutic goods covered by a single registration or listing number, no charge is payable under subsection 4 (1a) of the amended Act in relation to that financial year in respect of the registration or listing of therapeutic goods covered by the same registration or listing number.
NOTE
1. No. 22, 1990.
[Minister’s second reading speech made in—
House of Representatives on 31 May 1991 a.m.
Overview
The Therapeutic Goods (Charges) Amendment Act 1991 was enacted by the Parliament of Australia to amend the Therapeutic Goods (Charges) Act 1989. This legislation introduced specific amendments to address the need for charging regulations concerning therapeutic goods that are grouped under a single registration or listing number. The primary objective of this amendment is to ensure that appropriate annual charges are levied for grouped therapeutic goods, while also providing transitional provisions to manage the application of these charges in the financial year of enactment and subsequent years. By clarifying the scope of charges and providing specific guidelines for grouped therapeutic goods, the Act aims to maintain a consistent and fair regulatory framework for the therapeutic goods industry.
Scope and Application
The Therapeutic Goods (Charges) Amendment Act 1991 applies to the registration and listing of therapeutic goods, with a specific focus on grouped therapeutic goods that are covered by a single registration or listing number. The Act amends the Therapeutic Goods (Charges) Act 1989 by introducing an annual charge for grouped therapeutic goods if their registration or listing is in force during any financial year. The amendments apply to registrations or listings that commence on or after the date of commencement of the Act and to all registrations or listings in subsequent financial years. The Act has a national reach as it is a Commonwealth Act, thus applying across Australia. The Act also includes transitional provisions to ensure that therapeutic goods treated as single goods before the Act's commencement continue to be treated as such for certain purposes. The Act does not specify exclusions or exemptions but does address how existing regulations and charges are to be transitioned under the new provisions.
Key Provisions
The Therapeutic Goods (Charges) Amendment Act 1991 (C2004A04160) makes specific changes to the Therapeutic Goods (Charges) Act 1989 (referred to as the Principal Act). Section 3 of the Act amends Section 4 of the Principal Act to introduce a new requirement for an annual charge for grouped therapeutic goods. Specifically, subsection (1a) stipulates that if the registration or listing of one or more grouped therapeutic goods—which are goods covered by a single registration or listing number—is in force during any financial year, an annual charge must be paid for all the registrations or listings concerned. The amount of this charge is prescribed by regulations.
The Act imposes obligations on entities to ensure compliance with these new requirements. Manufacturers or suppliers who have grouped therapeutic goods must now account for the annual charges as per the new provisions. They must ensure that the appropriate fees are paid in respect of all grouped goods under a single registration or listing number for the duration of their financial year. This requirement applies to both new registrations or listings that commence after the Act's commencement date and to existing registrations or listings.
Failure to comply with the new charge provisions can lead to civil or criminal consequences. While the Act does not specify penalties, it is reasonable to infer that penalties would be similar to those outlined in the Principal Act, which may include fines and other civil penalties for non-compliance. These penalties serve to enforce adherence to the legislative requirements and ensure that the regulatory framework for therapeutic goods is effectively upheld.