67Exemptions

67 Exemptions

Exemptions for services—general (1) No fee is payable under this instrument for the provision of services if the submission or application for the services relates to: (a) a drug that is exempt from entry in the Australian Register of Therapeutic Goods because of an approval granted under section 19A of the Therapeutic Goods Act 1989; or (b) the supply of a drug, medicinal preparation or vaccine that the Secretary considers is necessary for the management of: (i) a public health event of national significance (within the meaning of the National Health Security Act 2007); or (ii) a biosecurity emergency that is declared to exist under subsection 443(1) of the Biosecurity Act 2015; or (iii) a human biosecurity emergency that is declared to exist under subsection 475(1) of the Biosecurity Act 2015. (2) No fee is payable under this instrument for the provision of services if the submission or application for the services seeks any of the following: (a) to offer a price reduction; (b) to change the name of the responsible person (as defined by subsection 84(1) of the Act) for a brand of a pharmaceutical item; (c) to vary a determination under subsection 9B(2) of the Act so that a vaccine ceases to be a designated vaccine; (d) to revoke a determination under subsection 9B(2) of the Act; (e) to vary a special arrangement under subsection 100(2) of the Act so that a drug or medicinal preparation ceases to be covered by the arrangement; (f) to revoke a special arrangement under subsection 100(2) of the Act; (g) to vary a declaration under subsection 101(4AAA) of the Act so that a drug or medicinal preparation ceases to be a listed drug; (h) to revoke a declaration under subsection 101(4AAA) of the Act; (i) to decrease the pack quantity (the existing pack quantity) of a listed brand of a pharmaceutical item if the amount that is to be the appropriate maximum price of the decreased pack quantity to be agreed under section 85AD of the Act will be calculated proportionally based on the approved ex‑manufacturer price of the existing pack quantity on the day before the agreement under that section takes effect; (j) to increase the pack quantity of a listed brand of a pharmaceutical item if the price for the increased pack quantity will be based on the proportional ex‑manufacturer price worked out under section 85D of the Act; (k) to vary a declaration, determination, arrangement or other legislative instrument made under section 9B or Part VII of the Act: (i) at the request of Services Australia or the Therapeutic Goods Administration; or (ii) that is a mandated change because of a Government initiative. (3) Subsections (1) and (2) do not apply in relation to: (a) services under Division 3 of Part 2 (about pre‑submission meetings); or (b) services under section 64 (about independent reviews). Exemption for submission services relating to designated orphan drugs (4) No fee is payable under this instrument for submission services provided in response to a person’s submission proposing a therapy involving the use of one or more drugs or medicinal preparations if: (a) on the day the submission is given to the Department, subsection (5) applies to each of those drugs or medicinal preparations; and (b) this subsection has not already applied to submission services provided in response to an earlier submission by the person proposing the same therapy involving the use of any of those drugs or medicinal preparations. (5) This subsection applies to a drug or medicinal preparation (the drug) on a day if: (a) on that day, the drug is a designated orphan drug; or (b) both: (i) on that day, the Secretary is yet to decide whether to include the drug in the Australian Register of Therapeutic Goods in response to an application made by the person on or before that day; and (ii) were the drug to be so included, the registration fees for doing so would be waived under paragraph 45(12)(c) of the Therapeutic Goods Regulations 1990 because the drug is a designated orphan drug; or (c) less than 12 months before that day, the drug was included in the Australian Register of Therapeutic Goods and the registration fees for doing so had been waived under paragraph 45(12)(c) of the Therapeutic Goods Regulations 1990 because the drug was a designated orphan drug. (6) For the purposes of paragraphs (5)(b) and (c) of this section, the registration fees are the fees described in paragraph 23B(2)(b) and subsection 24(1A) of the Therapeutic Goods Act 1989. Including reasons for exemption in submission or application or notice of intent (7) A person who has made a submission or an application for services under this instrument and who considers that subsection (1), (2) or (4) applies to provide a fee exemption for the services must include in the submission or application the reasons why that subsection applies to provide a fee exemption, unless the person has complied with subsection (8). (8) If a person: (a) proposes to make an ATAGI application, a submission or a pricing application in relation to which the person expects subsection (1), (2) or (4) to apply to provide a fee exemption; and (b) is required by section 9, 30 or 48 (as applicable) to give the Department a notice of intent in relation to the proposed ATAGI application, submission or pricing application; the person must include in the notice of intent the reasons why subsection (1), (2) or (4) of this section is expected to apply to provide a fee exemption.