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National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
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National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
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Turn the raw legal text into a practical explanation grounded in National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022.
ATAGI advice
ATAGI may, on application (an ATAGI application) by a person, provide advice to the person to be included in the person’s proposed submission to the Committee.
A fee is payable for the service of ATAGI providing the advice (unless a fee exemption applies or the fee is waived). The amount of the fee depends on whether the ATAGI application is categorised as complex or simple. A person may request the Secretary to decide whether the person’s ATAGI application is in a simple category.
The person will generally need to have given the Department a notice of intent in relation to the ATAGI application at least 10 business days before the ATAGI application due day for the application.
The ATAGI application must be given to the Department on or before the ATAGI application due day.
ATAGI will not provide advice in response to the ATAGI application if a notice of intent in relation to the ATAGI application 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If a notice of intent in relation to a proposed ATAGI application is withdrawn soon after it is given, or an ATAGI application is withdrawn soon after it is made, the fee amount (if any) paid, except the amount of the deposit included in the fee amount, will be refunded.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, a fee for the provision of administrative services by the Department in relation to the notice of intent or the ATAGI application will be payable.
Pre‑submission meetings
The Department may, on application (a pre‑submission meeting application) by a person, hold a pre‑submission meeting with the person in relation to the preparation of the person’s proposed submission to the Committee.
A fee is payable for the service of the Department holding the pre‑submission meeting. The amount of the fee depends on the category of the pre‑submission meeting.
If a pre‑submission meeting application is withdrawn before a certain time, the fee amount (if any) paid for the service of the Department holding the meeting will be refunded in full.