Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:67:p2
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 67 (pt 2/3)
Character Range: 127794–130507

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