Therapeutic Goods (Charges) Regulations (Amendment)

Overview

The Therapeutic Goods (Charges) Regulations (Amendment) 1994 No. 149 was enacted to amend the existing Therapeutic Goods (Charges) Regulations, which were made under the Therapeutic Goods (Charges) Act 1989. This amendment was introduced to address the need for more equitable and streamlined charges for the registration and listing of therapeutic goods and the licensing of manufacturers of such goods. The objective of these amendments was to align the charges for grouped therapeutic goods with those for other registrations and listings of equivalent classes of goods, as well as to exempt non-profit hospital supply units from annual licensing charges. The enacting body was the Governor-General, acting under the authority of the Minister for Family Services. These regulations were designed to ensure that the therapeutic goods regulatory framework remains fair and effective, promoting public health and safety while supporting the efficient operation of the therapeutic goods industry.

Scope and Application

The Therapeutic Goods (Charges) Regulations (Amendment) 1994 No. 149 applies to the Therapeutic Goods (Charges) Act 1989, which imposes an annual charge on the registration and listing of therapeutic goods and on the licensing of manufacturers of such goods. The Act applies to individuals and entities that are involved in the manufacture, registration, or listing of therapeutic goods within Australia. The regulations are established to govern the amounts of the charges, which include both annual registration or listing charges for therapeutic goods and annual licensing charges for manufacturers. These regulations also extend to setting the fees for therapeutic goods that are grouped under a single registration or listing number. Notably, the regulations introduce a new provision exempting non-profit hospital supply units from paying annual licensing charges, aligning with the existing exemption from licence and inspection fees provided for in the Therapeutic Goods Act 1989. The application of these regulations is national, covering the entire Commonwealth of Australia, and they come into effect upon gazette.

Key Provisions

The Therapeutic Goods (Charges) Regulations (Amendment) 1994 No. 149 amends the Therapeutic Goods (Charges) Regulations 1990 under the Therapeutic Goods (Charges) Act 1989. Section 4(1A) of the Act allows the Governor-General to make regulations that prescribe the annual registration or listing charge for therapeutic goods grouped under one registration or listing number (paragraph 4(1A)). This amendment standardises the annual charge for grouped therapeutic goods to align with the charges applicable to other registrations and listings of equivalent classes of goods (subregulation 2.1). Additionally, section 5 of the Act enables the Governor-General to prescribe the annual licensing charge for therapeutic goods manufacturers (paragraph 4(2)). The new regulation 4A inserted by subregulation 3.1 exempts non-profit hospital supply units from paying the annual licensing charge, in accordance with subsection 59(3) of the Therapeutic Goods Act 1989, which exempts such units from licence and inspection fees. The regulations impose specific obligations on entities involved in the registration, listing, and licensing of therapeutic goods. Firstly, for grouped therapeutic goods, registrants must now pay a standardised annual charge, as per the new subregulation 3(1A). This standardisation ensures that the charges are consistent across similar classifications of therapeutic goods. Secondly, non-profit hospital supply units are exempt from paying the annual licensing charge, aligning with the exemption from licence fees under subsection 59(3) of the Therapeutic Goods Act 1989. This exemption applies to units that operate without profit motives and supply therapeutic goods within a hospital setting. Registrants and licensees must ensure they are aware of these regulatory changes and adjust their compliance practices accordingly to avoid any inadvertent breaches. Breach of the Therapeutic Goods (Charges) Regulations 1990 can result in various civil and administrative consequences. While the amending regulations themselves do not explicitly state penalties for non-compliance, breaches of the underlying Therapeutic Goods (Charges) Act 1989 can incur significant penalties. Under section 13 of the Therapeutic Goods Act 1989, any person who contravenes a provision of the Act, including the regulations made under it, is liable to a penalty of up to $22,200 for an individual and $111,000 for a body corporate. Additionally, the Act provides for the recovery of costs associated with enforcement actions. Failure to pay the prescribed charges as per the regulations may also lead to the suspension or cancellation of the registration or listing of therapeutic goods, thereby impacting the ability of manufacturers and suppliers to legally distribute their products.