Document ID: chunk:federal_register_of_legislation:F2024C00984:front:0:p2
Version: federal_register_of_legislation:F2024C00984
Segment Type: other
Provision Reference: 
Character Range: 2797–5831

pre‑submission meeting applications
Part 3—Submission services
Division 1—Preliminary
20 Simplified outline of this Part
Division 2—Submissions to the Committee or Minister and fees
21 Submissions to Committee or Minister in relation to exercise of certain powers
22 Fees for providing submission services
23 Submissions in Category 1
24 Submissions in Category 2
25 Submissions in Category 3
26 Submissions in Category 4
27 Submissions in Committee Secretariat category
28 Submissions in new brand or new oral form of existing pharmaceutical item category
29 Evaluation categories of certain remade submissions
Division 3—Procedure for making submissions and giving notice of intent
30 Notice of intent required for most submissions
31 Requirements for submissions
32 Economic evaluation to support submission in Category 1 or Category 2
33 Notification, including amount of fee payable
34 Secretary may refuse to accept incomplete submission
35 Withdrawal of notice of intent or submission, and refund of fee or liability for deposit
36 Remaking submission
Division 4—Determining evaluation category and assessing submissions
37 Determining evaluation category that submission is in
38 Assessing submissions
Part 4—Pricing services
Division 1—Preliminary
39 Simplified outline of this Part
Division 2—Pricing applications and fees
40 Applications for pricing services
41 Fees for providing pricing services
42 Pricing applications in Pricing Pathway A category
43 Pricing applications in Pricing Pathway B category
44 Pricing applications in Pricing Pathway C category
45 When pricing terms are substantially similar to those appropriate for the new drugs
46 Pricing applications in Pricing Pathway D category
47 Pricing applications in Pricing Secretariat category
Division 3—Procedure for making pricing applications and giving notice of intent
48 Notice of intent required for most pricing applications
49 Requirements for pricing applications
50 Notification, including amount of fee payable
51 Withdrawal of notice of intent or pricing application, and refund of fee or liability for deposit
Division 4—Determining pricing category of pricing applications
52 Determining pricing category that pricing application is in
Division 5—Cessation of pricing services 6 months after pricing application is made
53 Cessation of pricing services 6 months after pricing application is made
54 Refund if deed not made within 6 months after pricing application is made
Part 5—List management services
55 Simplified outline of this Part
56 Fees for providing list management services
57 Requirements for list management applications
58 Notification, including amount of fee payable
59 Withdrawal of list management application, and refund of fee
60 Refund of part of fee if replacement for expired deed not made
Part 6—Fees: common rules and independent review fee
61 Simplified outline of this Part
62 Payment of fees
63 Delay in paying fee
64 Independent review fee
65 Refund or remission of fees if services not provided
Part 7—Exemptions