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Guidance 2: Fees and charges for prescription medicines
2.7 When evaluation fees are waived or reduced for prescription medicines
Application and evaluation fees can be waived or reduced under the following circumstances, as prescribed by the Regulations.
2.7.1 Orphan drugs
If a product has been designated as an orphan drug in accordance with r. 16J, then pursuant to subregulation 45(12)(c), the application and evaluation fees for an application submitted under s. 23 of the Act will be waived.
However, full fees will apply to all variations to an orphan drug (i.e. applications submitted under s. 9D). Designation as an orphan drug must occur before any application to register the product is lodged.
2.7.2 Supply of medicines in response to a public health emergency
In accordance with subregulation 45(4AA), the Regulations provide the Secretary (or delegate), in limited circumstances, with the discretion to waive or reduce an evaluation fee prescribed in Schedule 9 in relation to goods of a kind mentioned in Part 1 of Schedule 10 to address an actual public health emergency.
In determining whether to waive or reduce the evaluation fee under subregulation 45(4AA), the Secretary (or delegate) must consider that:
- supply of the goods in Australia is necessary because of a public health emergency; and
- the waiver or reduction is necessary to enable the goods to be supplied in Australia; and
- the Secretary has information relating to the goods that allows the evaluation procedure to be abridged.
In any request under subregulation 45(4AA), the applicant must address all three elements for the Secretary (or delegate) to appropriately consider the request. The applicant will still be required to pay the full application fee. Applicants who believe that they qualify for this provision should contact the TGA.