Payment of evaluation and assessment fees by instalment
April 2007
Instalment payment of fees for evaluations and assessments may be approved where financial hardship can be demonstrated.
Key points
- Evaluation fees are due and payable at the time of submission or prior to commencement of an evaluation.
- The TGA may approve an instalment payment plan where the payment of the fee would result in financial hardship.
- Instalment payment plans will be designed to ensure full payment is made prior to the determination of an evaluation.
- Conditions, including interest, may be applied for an approved instalment plan.
Procedures
The TGA's application and evaluation fees are debts due and owing to the Commonwealth and are payable at the time of submission. This ensures continuous evaluation processing, avoids unnecessary administrative costs and limits the TGA's exposure to bad debts and debt recovery costs.
Sponsors that believe they will experience financial hardship as a result of making full payment prior to the commencement of an evaluation may apply in writing for an instalment plan.
An instalment payment plan is provided in the Therapeutic Goods Regulations for certain medical device evaluations and conformity assessments that exceed $10,000.
- Applications must be made in writing and include supporting information demonstrating financial hardship (financial statements, budget projections etc).
- The instalment plan that may be approved is 50% of the fee prior to commencement; 25% to be made 30 days later; with the balance payable on completion or withdrawal of the application by the applicant.
- Failure to make an instalment payment by the agreed date will result in the balance of the amount being payable in full.
- The TGA cannot consider a request for instalment payment whilst another evaluation fee or instalment payment plan remains unpaid.
The TGA will advise the applicant in writing within 30 days of the decision to grant instalment payments.
The TGA may also make an instalment payment plan on a debt owing to the Commonwealth on such terms and conditions as are considered appropriate.
- Applications must be made in writing and include supporting information demonstrating financial hardship (financial statements, budget projections etc).
- Payment plans will usually be designed to be completed in the quickest possible time.
- Payment plans that extend beyond the financial year will ordinarily have interest imposed on the debt.
- Full payment will be required to be made prior to the determination of the application (the decision).
- Failure to make an instalment payment by the agreed date will result in the balance of the amount being payable immediately.
The TGA will advise the applicant in writing of a decision to grant instalment payments and require applicants to agree to the conditions relating to the instalment payment plan in writing.
Forms
Not applicable
Assistance
TGA Operations Manager: Facsimile 02 6232 8222 or by email to TGA.Accounts@tga.gov.au.
References
Therapeutic Goods Act 1989
- Section 24 defines a fee as a debt due and payable to the Commonwealth.
- Sections 24B and 41LC allow Regulations to be made for payment of certain fees by instalments.
Therapeutic Goods Regulations 1990
- Regulation 45AA sets out provisions for instalment payments of certain fees for medical devices valued at more than $10,000.
Financial Management and Accountability Act 1997
- Paragraph 43(1)(c) permits the payment of a debt by instalment.