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Guidance 2: Fees and charges for prescription medicines
Previously ARGPM Appendix 2: Fees and charges
12 July 2013
Introduction
This guidance:
- outlines the types of fees for services that apply to the registration of prescription medicines, and the variation of existing registrations.
- provides an overview of the various types of applications to do with prescription medicines.
- explains when payments are required for the various types of applications to register prescription medicines or to vary information on the Australian Register of Therapeutic Goods (ARTG) about prescription medicines.
- describes the provisions in the Therapeutic Goods Regulations 1990 (the Regulations) for waiving or reducing fees and charges, and provides information about refunds.
- explains what annual charges are.
Contents
- 2.1 Background to fees and charges
- 2.2 When to make an application under sections 23 or section 9D of the Act
- 2.3 When to pay application and evaluation fees for prescription medicines
- 2.4 Fees for prescription medicine applications made under section 23 of the Act
- 2.5 Fees for requests to vary an ARTG entry for prescription medicines under section 9D of the Act
- 2.6 Other fees that apply to prescription medicines
- 2.7 When evaluation fees are waived or reduced for prescription medicines
- 2.8 When application fees are refunded for prescription medicines
- 2.9 Annual charges for prescription medicines
- Annex 1
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Office of Medicines Authorisation | 12/07/2013 |