National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
20Simplified outline of this Part
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20 Simplified outline of this Part
Submission services may be provided in response to a person’s submission to the Committee or the Minister for those services. A fee is payable for providing the submission services (unless a fee exemption applies or the fee is waived). The amount of the fee depends on the evaluation category the submission is in, which depends on what the submission is for. If the submission is for more than one thing, the evaluation category is generally determined by the first provision of this Part about evaluation categories that applies to the submission.
If the person’s submission is to the Committee, the person will generally need to have given the Department a notice of intent in relation to the submission at least 20 business days before the day (the submission due day) the Committee requires submissions for the Committee meeting that will be considering the submission. The submission due day depends on the evaluation category the submission is in.
The notice of intent in relation to the submission must state the likely evaluation category of the person’s submission. The person will generally be charged a fee for the submission services based on this evaluation category.
If the Secretary later determines that the submission is in a different evaluation category, the person will be notified and any difference in the fee payable will be refunded or charged as appropriate.
If the person’s submission is to the Committee, submission services will not be provided in response to the submission if a notice of intent in relation to the submission was not given, unless a notice of intent was not required because of an urgent public health need.
If a notice of intent in relation to a proposed submission is withdrawn soon after it is given, or a submission is withdrawn soon after it is made, in most cases, the fee amount (if any) paid, except the amount of the deposit included in the fee amount, will be refunded. If no fee amount was paid before the withdrawal, in most cases, a fee for the provision of administrative services by the Department in relation to the notice of intent or the submission will be payable.