Therapeutic Goods Amendment Regulations 2000 (No. 3) 2000 No. 70
EXPLANATORY STATEMENT
STATUTORY RULES 2000 No. 70
Issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care
Therapeutic Goods Act 1989
Therapeutic Goods Amendment Regulations 2000 (No. 3)
The object of the Therapeutic Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
The Governor-General may, under section 63 of the Act, make regulations for the purposes of the Act. In particular, the Governor-General may, under subsection 63(1) and paragraphs 63(2)(h) and (3)(a), make regulations prescribing a range of fees including application, processing or evaluation fees payable in connection with the processing of applications to include therapeutic goods in the Australian Register of Therapeutic Goods (the Register) and the variation of information contained in the Register about those goods.
These regulations increase two fees payable under Schedule 9 of the Therapeutic Goods Regulations. The Regulations increase:
* the application fee payable by sponsors who apply to list their medicines in the Register; and
* a processing fee payable by persons who apply to vary information about their medicines contained in the Register. This processing fee is not associated with any evaluation of information and data that may support the application, but reflects the administration costs involved in processing the application, making the appropriate changes to information contained in the Register and supporting decisions and actions taken in relation to this activity.
These costs are required to be recovered because the TGA is required to operate on a total cost recovery basis. The increases have been discussed with the peak industry association representing importers, exporters and manufacturers of listable medicines.
Details of the Regulations are set out in the Attachment.
The Regulations commence on 1 July 2000.
ATTACHMENT
Therapeutic Goods Amendment Regulations 2000 (No. 3)
Regulation 1 states that the title of the regulations is the Therapeutic Goods Amendment Regulations 2000 (No. 3 ).
Regulation 2 provides that the regulations commence from 1 July 2000.
Regulation 3 provides that the regulations amend the Therapeutic Goods Regulations 1990 as provided in Schedule 1.
SCHEDULE 1 - AMENDMENTS
Item 1 increases the fees payable for lodging an application to list medicines in the Australian Register of Therapeutic Goods (the Register) from $270 to $400.
Item 2 increases the processing fee, payable for processing an application seeking to amend information about the applicant's medicine or medicines recorded in the Register, from $100 to $200. These fees do not cover work associated with evaluating information or data that may be lodged to support certain changes being sought.
Overview
The Therapeutic Goods Amendment Regulations 2000 (No. 3) were enacted to address the need for cost recovery in the administration of the Therapeutic Goods Act 1989. This Act aims to establish a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA), which is responsible for administering the Act, operates on a total cost recovery basis, necessitating the adjustment of fees to reflect the costs involved in processing applications for listing medicines in the Australian Register of Therapeutic Goods and for varying information about medicines in the Register. The regulations were issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care and reflect a policy objective to ensure the TGA's financial sustainability while maintaining efficient operations. These amendments were discussed with relevant industry associations to ensure transparency and stakeholder engagement.
Scope and Application
The Therapeutic Goods Amendment Regulations 2000 (No. 3) apply to entities and individuals who are involved in the regulation and administration of therapeutic goods in Australia, specifically those who are required to submit applications to list medicines in the Australian Register of Therapeutic Goods or to vary information about their medicines contained in the Register. This includes pharmaceutical companies and other sponsors of therapeutic goods, as well as the Therapeutic Goods Administration (TGA), which is responsible for administering the Therapeutic Goods Act 1989. The regulations have a national reach, as they pertain to the quality, safety, efficacy and timely availability of therapeutic goods used or exported from Australia. The regulations do not specify any exclusions or exemptions, and apply to all relevant entities and individuals without distinction. The application and processing fees specified in the regulations are subject to change through subordinate instruments, as the TGA is required to operate on a total cost recovery basis. The increases in fees have been discussed with relevant industry associations.
Key Provisions
The Therapeutic Goods Amendment Regulations 2000 (No. 3) primarily revise the fees associated with listing and varying information about therapeutic goods within the Australian Register of Therapeutic Goods (the Register). Specifically, Regulation 1 identifies these regulations as the Therapeutic Goods Amendment Regulations 2000 (No. 3), while Regulation 2 sets the commencement date of these amendments as 1 July 2000. Regulation 3 specifies that these regulations will amend the Therapeutic Goods Regulations 1990, as detailed in Schedule 1.
Schedule 1 of the regulations outlines two key amendments. Item 1 increases the application fee for listing medicines in the Register from $270 to $400. This fee is applicable to sponsors who seek to include their medicines in the Register. Item 2 increases the processing fee from $100 to $200 for applications to vary information about medicines already listed in the Register. Notably, this fee pertains solely to the administrative costs involved in processing the application and updating the Register, and does not cover the evaluation of any supporting information or data.
The Therapeutic Goods Amendment Regulations 2000 (No. 3) impose several obligations on parties involved with therapeutic goods. Sponsors who wish to list their medicines in the Register must now pay an increased application fee of $400. Similarly, parties seeking to modify information about their listed medicines must pay a processing fee of $200. These fees are necessary to ensure that the Therapeutic Goods Administration (TGA) can operate on a total cost recovery basis, thereby maintaining the efficiency and effectiveness of the regulatory process.
Failure to comply with the fee requirements outlined in the Therapeutic Goods Amendment Regulations 2000 (No. 3) could result in legal consequences. While the regulations themselves do not explicitly outline specific offences or penalties for non-payment or underpayment of fees, failure to adhere to these requirements could lead to broader regulatory sanctions under the Therapeutic Goods Act 1989. The Act includes provisions for penalties, including fines and imprisonment, for non-compliance with its regulatory framework. However, the specific penalties for fee-related non-compliance would depend on the particular circumstances and any additional legislation or guidelines issued under the Act.