Therapeutic Goods (Charges) Regulations (Amendment) 1993 No. 140
EXPLANATORY STATEMENT
STATUTORY RULES 1993 No. 140
Issued by Authority of the Minister for Family Services
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Regulations (Amendment)
The Therapeutic Goods (Charges) Act 1989 (the Act) imposes an annual charge for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods, and an annual charge for licences to manufacture therapeutic goods.
Subsection 5(1) of the Act empowers the Governor-General to make regulations, not inconsistent with the Act, prescribing the amounts of those charges.
The increases in charges contained in the Regulations have been made in conjunction with the increases in fees made under the accompanying Therapeutic Goods Regulations (Amendment). The increases have been necessitated by the need to meet the Government's decision of August 1989 that the Therapeutic Goods Administration, which administers the Act, operate on a fifty pet cent cost recovery basis, with revenue to be drawn from fees and charges collected from industry. To minimise the impact of the increase in charges to industry, it has been agreed between industry and Government that the proposed higher charges will be phased in over a four year period. The Therapeutic Goods (Charges) Regulations (Amendment) therefore introduce the first incremental increases to a range of annual charges for maintaining registrations and listings of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and to a range of manufacturing licences issued for either different kinds of therapeutic goods or for different kinds of manufacturing processes.
Details of the Regulations are as follows.
Regulation 1 provides for the Regulations to commence on 1 July 1993.
Regulation 2 provides for the Therapeutic Goods (Charges) Regulations to be amended as provided in these Regulations.
Subregulation 3.1 increases the annual charge for registrations of prescription drugs in the Register from $350 to $400.
Subregulation 3.2 increases the annual charge for registrations of all other therapeutic goods from $175 to $210.
Subregulation 3.3 increases the annual charge for listings of therapeutic goods. Therapeutic goods listed in the Register that are produced for export only do not attract an annual charge for their listing.
Subregulations 3.4, 3.5 and 3.6 increase annual licensing charges payable for three broad categories of manufacturing licences - those for the manufacture of therapeutic goods or their containers, those for the manufacture of ingredients or components of therapeutic goods, or a single step of manufacture or the manufacture of a single product, and those for the manufacture of herbal or homoeopathic preparations not included in a Schedule to the Poisons Standard.
Regulation 4 amends subregulation 4(1) of the Charges Regulations by resetting the formula for determining the cut-off point at which annual registration/listing charges would not be payable by a sponsor whose wholesale turnover of therapeutic goods is of "low volume and low value". Currently, the formula is set at 2 per cent of the value of the wholesale turnover. This is to be replaced by 5 per cent.
The Regulations commence on 1 July 1993.
Overview
The Therapeutic Goods (Charges) Regulations (Amendment) 1993 No. 140 were introduced to address the need for increased cost recovery by the Therapeutic Goods Administration, which administers the Therapeutic Goods (Charges) Act 1989. Enacted by the Governor-General under the authority of the Minister for Family Services, these regulations amended the Therapeutic Goods (Charges) Regulations to increase annual charges for the registration and listing of therapeutic goods, as well as for manufacturing licences. The policy objective was to align the administration's operating costs with a fifty percent cost recovery basis, with fees and charges collected from industry. To mitigate the impact on industry, the increased charges were to be phased in over four years. This amendment introduced the first set of incremental increases to a range of annual charges, including those for maintaining registrations and listings of therapeutic goods, and for different categories of manufacturing licences.
Scope and Application
The Therapeutic Goods (Charges) Regulations (Amendment) 1993 applies to entities and individuals involved in the registration, listing, and manufacturing of therapeutic goods in Australia, as governed by the Therapeutic Goods (Charges) Act 1989. These regulations primarily affect pharmaceutical companies, healthcare product manufacturers, and other entities that require therapeutic goods to be registered or listed in the Australian Register of Therapeutic Goods, as well as those holding manufacturing licences for therapeutic goods. The amendments impose higher annual charges for maintaining these registrations and listings, and for manufacturing licences, aligning with the government's policy for the Therapeutic Goods Administration to operate on a 50 per cent cost recovery basis. The new charges are phased in over four years to mitigate their impact on industry. These regulations have a national reach across Australia, given that the Therapeutic Goods (Charges) Act 1989 is a Commonwealth Act. The amendments do not introduce new exclusions or exemptions but adjust the formula for determining when annual registration or listing charges would not be payable by a sponsor with a low volume and low value wholesale turnover of therapeutic goods, resetting it from 2 per cent to 5 per cent of the value of the wholesale turnover.
Key Provisions
The Therapeutic Goods (Charges) Regulations (Amendment) 1993 No. 140 amends the existing Therapeutic Goods (Charges) Regulations by increasing various charges related to the registration and listing of therapeutic goods, as well as manufacturing licenses. Specifically, Regulation 3 increases the annual charges for the registration and listing of therapeutic goods (subregulations 3.1 to 3.3) and for manufacturing licenses (subregulations 3.4 to 3.6). Regulation 4 modifies the formula used to determine when a sponsor’s wholesale turnover of therapeutic goods is considered low enough to exempt them from certain annual charges, by raising the threshold from 2 per cent to 5 per cent of the value of the wholesale turnover.
Entities and parties governed by the Therapeutic Goods (Charges) Act 1989 are required to pay the increased charges as stipulated in the amended Regulations. For example, sponsors of therapeutic goods must now pay higher annual fees for maintaining registrations and listings in the Australian Register of Therapeutic Goods. Similarly, holders of manufacturing licenses must comply with the new licensing fee structure. The changes in the formula for determining low volume and low value thresholds also affect the eligibility of sponsors for exemption from certain annual charges.
Failure to comply with the new charge requirements can result in financial penalties. While the Explanatory Statement does not specify exact penalties, non-compliance with charges under the Therapeutic Goods (Charges) Act 1989 can typically lead to enforcement actions by the Therapeutic Goods Administration. This may include fines or other civil or administrative penalties, as prescribed by the Act or related legislation. Additionally, ongoing non-compliance could potentially lead to more severe consequences, such as the suspension or revocation of registrations, listings, or manufacturing licenses.