Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:39
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 39
Character Range: 78528–80951

39  Simplified outline of this Part

      Pricing services in relation to one or more drugs or medicinal preparations may be sought after a meeting of the Committee that results in the Committee making a positive recommendation, or giving positive advice, in relation to the drugs or medicinal preparations.
      Pricing services may be provided in response to a person's pricing application. A fee is payable for providing the pricing services (unless a fee exemption applies or the fee is waived). The amount of the fee depends on the category of the person's pricing application.
      The person will generally need to have given the Department a notice of intent in relation to the proposed pricing application at least 5 business days before making the application.
      The notice of intent must state the category that the pricing application is likely to be in. The person will generally be charged a fee for the pricing services based on this category.
      If the Secretary later determines that the pricing application is in a different category, the person will be notified and any difference in the fee payable will be refunded or charged as appropriate.
      Pricing services will be delayed if a notice of intent in relation to the pricing application was not given, unless a notice of intent was not required because of an urgent public health need.
      The pricing application must be given to the Department within 30 business days after the notice of intent is given.
      If a notice of intent in relation to a proposed pricing application is withdrawn soon after it is given, or a pricing application is withdrawn soon after it is made, in most cases, the fee amount (if any) paid, except the amount of the deposit included in the fee amount, will be refunded.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, a fee for the provision of administrative services by the Department in relation to the notice of intent or the pricing application will be payable.
      Six months after a pricing application is made, the Commonwealth may cease to provide the pricing services applied for if the Secretary is satisfied that negotiations relevant to the pricing services have not concluded successfully and are not continuing because of the applicant's inaction. If the ceased services relate to a proposed deed, a refund of part of the fee is available.

Division 2—Pricing applications and fees