Document ID: chunk:federal_register_of_legislation:F2025C00036:front:0:p6
Version: federal_register_of_legislation:F2025C00036
Segment Type: other
Provision Reference: 
Character Range: 14897–18298

charge is payable if turnover is not of low value
Subdivision 2A—Exemption from liability to pay annual charge—IVD devices
43AAGA Purpose of this Subdivision
43AAGB Exemption from liability to pay annual charge—2017‑18 financial year
43AAGC Exemption from liability to pay annual charge—financial years commencing on or after 1 July 2018
43AAGD Exemption from liability to pay annual charge—late notice that turnover was of low value
43AAGE Person may notify Secretary that turnover of IVD device for financial year will not be of low value
43AAGF Secretary may notify person that annual charge is payable if turnover is not of low value
Subdivision 2B—Waiver of certain annual charges
43AAGG Purpose of Subdivision
43AAH Waiver of certain annual charges
Subdivision 3—Charges for licensing
43AAJ Licensing charge—reduction in certain circumstances
Division 2—Fees and costs
43 Fees
43A When is no application fee payable?
43AA Fee for evaluation—refund in certain circumstances
43AB Circumstances in which inspection fee covered by annual charge
43AC Refund of fees where no evaluation undertaken—registered OTC medicines
43ACA Refund of fees where no evaluation undertaken—certain registered and listed medicines
43AD Fee for therapeutic goods (priority applicant) determination application—refund in certain circumstances
43AE Fee for application for provisional determination relating to medicine—refund in certain circumstances
43AF Fee for request for variation of certain registered and listed medicines—refund in certain circumstances
44 Testing of samples—recovery of costs
45 Waiver or reduction of fees
45AA Payment of fees in instalments
Part 8—Miscellaneous
46AA Identity cards for authorised officers
46A Delegation under the Act
46B Protected persons
46 Release of information
47 Delegation—powers and functions under these Regulations
47A Delegation—powers under paragraphs 19(1)(a), 32CK(1)(d) and 41HB(1)(d) of the Act
47B Provision of information concerning medicines, biologicals and medical devices
47C Enforceable directions
48 Review of decisions
Part 9—Transitional
Division 1—Transitional provisions relating to the Therapeutic Goods Amendment Regulations 2010 (No. 1)
48A Definitions
48B Application of 2010 Amendment Regulations
Division 2—Transitional provisions relating to the Therapeutic Goods Amendment Regulation 2012 (No. 3)
49 Transitional
Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015
50 Application
Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
51 Application
Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017
52 Definitions
53 Transitional—continuing application of evaluation fees for variations of permissible ingredients determinations
54 Transitional—existing orphan drug designations
55 Transitional—pending orphan drug designation applications
56 Transitional—fee waivers in relation to certain designations
Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017
57 Definitions
58 Application—statements in relation to unapproved medicines and biologicals
59 Transitional—approval of form for statements
Division