Therapeutic Goods (Charges) Regulations (Amendment)

Overview

The Therapeutic Goods (Charges) Regulations (Amendment) 1996 No. 132 was enacted to introduce the fourth incremental increase to a range of annual charges for maintaining registrations and listings of therapeutic goods in the Australian Register of Therapeutic Goods, as well as for manufacturing licences issued for the manufacture of therapeutic goods. This amendment was made under the authority of the Minister for Health and Family Services and is consistent with the Therapeutic Goods (Charges) Act 1989. The policy objective is to ensure the Therapeutic Goods Administration (TGA) operates on a fifty per cent cost recovery basis, with revenue generated from fees and charges collected from industry. To mitigate the impact on industry, the higher charges are phased in over a four-year period. The increases in charges contained in the Regulations are made in conjunction with the fees under the accompanying Therapeutic Goods Regulations (Amendment). The Regulations were designed in consultation with industry to ensure a fair and gradual implementation of the increased charges.

Scope and Application

The Therapeutic Goods (Charges) Regulations (Amendment) 1996 No. 132 amends the Therapeutic Goods (Charges) Regulations 1990 to introduce the fourth incremental increase to a range of annual charges for maintaining registrations and listings of therapeutic goods in the Australian Register of Therapeutic Goods, as well as for maintaining licences to manufacture therapeutic goods. These amendments apply to all entities and individuals who are required to pay these charges under the Therapeutic Goods (Charges) Act 1989. The Act applies to therapeutic goods, which include medicines, medical devices, blood and blood components, tissues, and therapeutic goods that are regulated under the Act. The application of the Act is national in scope, covering the entire Commonwealth of Australia. The Regulations, which are subordinate instruments of the Act, extend the application by detailing the specific charge increases and the phased implementation over a four-year period. These charges are implemented to ensure that the Therapeutic Goods Administration operates on a fifty per cent cost recovery basis, drawing revenue from fees and charges collected from industry.

Key Provisions

The Therapeutic Goods (Charges) Regulations (Amendment) 1996 No. 132 introduces amendments to the Therapeutic Goods (Charges) Regulations, adjusting the annual charges for maintaining registrations and listings of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and for maintaining licences to manufacture therapeutic goods. These amendments are made pursuant to the authority granted under section 5(1) of the Therapeutic Goods (Charges) Act 1989. The primary aim of these amendments is to introduce the fourth incremental increase in charges over a four-year period. This phased approach was agreed upon with the industry to mitigate the financial impact on businesses. Under these Regulations, the entities subject to the Act are required to pay the increased annual charges as set out in Regulation 2. The amendments specify the new rates for various categories of therapeutic goods, including those for maintaining listings, registrations, and manufacturing licences. These entities must ensure they comply with the new charge structure by the commencement date of 1 July 1996. Failure to comply with these payment obligations can lead to further administrative actions by the Therapeutic Goods Administration (TGA). In the event of non-compliance with the payment of the revised charges, the Regulations do not explicitly state specific offences or penalties. However, non-compliance generally falls under the purview of the Therapeutic Goods (Charges) Act 1989, which may include actions such as fines or other administrative penalties. The TGA, as the administering body, may take enforcement actions against entities that fail to adhere to the payment requirements. It is important for entities governed by these Regulations to ensure timely and accurate payments to avoid any potential repercussions.