Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3) 2000 No. 266
EXPLANATORY STATEMENT
STATUTORY RULES 2000 No. 266
Issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3)
The object of the Therapeutic Goods Act 1989 is to establish and maintain a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. To this end, therapeutic goods that are manufactured in Australia or imported into Australia must meet acceptable manufacturing standards. In Australia, each step of manufacture of therapeutic goods must, unless the goods have been exempted from this requirement, be manufactured under licence.
Section 3 of the Therapeutic Goods (Charges) Act 1989 (the Act) states that the Therapeutic Goods Act 1989 is incorporated, and is to be read as one, with the Act.
Subsection 4(2) of the Act provides that annual charges are payable for maintaining manufacturing licences during a financial year.
Section 5 of the Act provides that the Governor-General may make Regulations to prescribe the level of charges including those that are payable for maintaining manufacturing licences from year to year.
The purposes of these amendments is to prescribe an annual charge for maintaining licences now required to be taken out by manufacturers of blood and blood components. This requirement came into effect in July 2000. The charges are necessary to give effect to the Government's policy that the Therapeutic Goods Administration operate on a full cost-recovery basis. Industry has been extensively consulted on the new charges, which are linked to the recovery of operating costs.
The annual charge for maintaining a licence to manufacture blood and blood components will be $8,000 for the metropolitan or principal manufacturing site covered by a licence, and $1,950 for each additional fixed (non-mobile) site covered by the same licence. These new charges are set out in Item 2 of Schedule 1 of the amending Regulations. Item 1 of Schedule 1 makes a typographical correction.
The Regulations commenced on gazettal.
Overview
The Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3) were enacted to address the need for annual charges for maintaining manufacturing licences, specifically for manufacturers of blood and blood components, in accordance with the Therapeutic Goods (Charges) Act 1989. This Act was established to regulate the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia, requiring manufacturers to meet acceptable standards and obtain necessary licences. The Regulations were issued under the authority of the Parliamentary Secretary to the Minister for Health and Aged Care, reflecting the Government's policy of ensuring the Therapeutic Goods Administration operates on a full cost-recovery basis. The new charges, determined after extensive consultation with industry, are intended to recover the operating costs associated with the regulation of blood and blood component manufacturing, with a set annual charge of $8,000 for the primary manufacturing site and $1,950 for each additional fixed site.
Scope and Application
The Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3) establish the annual charges for maintaining manufacturing licences for blood and blood components, in accordance with the Therapeutic Goods (Charges) Act 1989. These Regulations apply to entities that manufacture blood and blood components within Australia and require these manufacturers to obtain and maintain a licence to ensure that their products meet the required quality, safety, efficacy, and timely availability standards. The charges are intended to ensure that the Therapeutic Goods Administration operates on a full cost-recovery basis and are set at $8,000 for the metropolitan or principal manufacturing site, and $1,950 for each additional fixed (non-mobile) site covered by the same licence. The Regulations are national in scope, applying across all states and territories in Australia. The charges prescribed by these Regulations commenced on gazettal and are linked to the recovery of operating costs.
Key Provisions
The main operative sections of the Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3) include Section 4(2) of the Therapeutic Goods (Charges) Act 1989, which requires annual charges for maintaining manufacturing licences. This section is supplemented by Section 5 of the Act, which empowers the Governor-General to establish Regulations prescribing the level of these charges. The amendments introduced by these Regulations, specifically in Item 2 of Schedule 1, establish the annual charge for maintaining a licence to manufacture blood and blood components. These charges are $8,000 for the metropolitan or principal manufacturing site and $1,950 for each additional fixed site covered by the same licence.
The Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3) impose obligations on manufacturers of blood and blood components to pay the prescribed annual charges. These charges are necessary for the ongoing maintenance of the manufacturing licences required under the Therapeutic Goods Act 1989. Manufacturers must ensure compliance with the new charge structure, which was established to align with the government's policy of full cost recovery for the Therapeutic Goods Administration. This includes keeping abreast of the regulatory changes and ensuring timely payment of the specified charges for each licenced manufacturing site.
Breaching the obligations outlined in the Regulations may result in civil and administrative consequences. Although the specific penalties are not detailed in the explanatory statement, it is implied that failure to comply with the prescribed charges and licence maintenance requirements could lead to the suspension or revocation of the manufacturing licence. This would potentially disrupt the manufacture and supply of blood and blood components, impacting both the manufacturer and the availability of these critical therapeutic goods. The precise penalties for non-compliance would likely be outlined in the Therapeutic Goods Act 1989 or other related legislation.