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Guidance 2: Fees and charges for prescription medicines
2.2 When to make an application under sections 23 or section 9D of the Act
Broadly, the prescription medicine fees relate to:
- application fees and evaluation fees for entering prescription medicines in the ARTG under s. 23 of the Act
- application fees and evaluation fees to vary the registration details of existing ARTG entries under s. 9D of the Act
- other miscellaneous matters, such as:
- applications to obtain consent to supply prescription medicines that do not comply with certain aspects of an applicable standard under ss. 14/14A of the Act, and
- fees for providing advice to the Pharmaceutical Benefits Program.
2.2.1 What section of the Act to apply under?
Whether an application should be submitted under s. 23 or a request made under s. 9D of the Act depends on whether:
- a sponsor wishes to market (import, export, manufacture or supply) a prescription medicine that the sponsor has not entered in the ARTG, or whether
- a sponsor whose prescription medicine is already entered in the ARTG wishes to make changes to information about this prescription medicine or make changes to their prescription medicines of a kind that is described in s. 9D of the Act.
2.2.2 What is a submission?
A submission refers to one or more simultaneous applications of the same kind with the same active ingredient, lodged by the same sponsor. For example, multiple applications lodged by an applicant simultaneously for a new chemical entity under item 4(a) of Part 2, Schedule 9 would constitute a submission. A simultaneous or concurrent application from, or on behalf of, another applicant is a separate submission.
Both application and evaluation fees are payable on a 'per submission' basis.
Subclauses 1(2) and 1(3) of Part 1, Schedule 9 of the Regulations describe what constitutes a submission for particular kinds of applications (these subclauses apply to applications concerning prescription medicines referred to in paragraph (a) of item 2A and items 2B, 2C, 2CA and 4 of Part 2 of Schedule 9).