Commonwealth Consolidated Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES--COST RECOVERY) REGULATIONS 2022

- made under the National Health Act 1953

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.      Name  
   3.      Authority  
   5.      Definitions  

   PART 2--PRE---SUBMISSION SERVICES

           Division 1--Preliminary

   6.      Simplified outline of this Part  

           Division 2--ATAGI advice

   7.      Fee for providing ATAGI advice  
   8.      Reduced fee for ATAGI applications in simple category  
   9.      Notice of intent required for most ATAGI applications  
   10.     Requirements for ATAGI applications  
   11.     Notification, including amount of fee payable  
   12.     Withdrawal of notice of intent or ATAGI application, and refund of fee or liability for deposit  
   13.     Remaking ATAGI applications  

           Division 3--Pre-submission meetings

   14.     Fees for holding pre - submission meetings  
   15.     Requirements for pre - submission meeting applications  
   16.     Agreeing to hold pre - submission meeting  
   17.     Notification, including amount of fee payable  
   18.     Withdrawal of pre - submission meeting application, and refund of fee  
   19.     Remaking 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--AND WAIVERS

   66.     Simplified outline of this Part  
   67.     Exemptions  
   68.     Waiver of fees for provision of ATAGI advice, submission services or pricing services  
   69.     Waiver of fees for provision of list management services  

   PART 8--REVIEW--OF DECISIONS

   70.     Simplified outline of this Part  
   71.     Reviewable decisions  
   72.     Notice of review rights  
   73.     Internal review  
   74.     Secretary may initiate internal review  
   75.     Notice of fee adjustment  
   76.     Review by the Administrative Review Tribunal  

   PART 9--APPLICATION--AND TRANSITIONAL PROVISIONS

           Division 1--Application of this instrument as originally made

   77.     Definitions for this Division  
   78.     Submission or application for the provision of services received on or after commencement day  
   79.     Prior notice of certain applications given before commencement day  
   80.     Application for services received, but notification not given, before commencement day  
   81.     Application for services received, and notification given, before commencement day  
   82.     ATAGI application made, but waiver of fee not requested, before commencement day  
   83.     Review of decisions made under the old Regulations  
   84.      Things done under the old Regulations  

           Division 2--Amendments made by the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2022

   85.     Application provision for the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2022  

           Division 3--Amendments made by the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2023

   86.     Application provision for the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2023  

           Division 4--Amendments made by the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2024

   87.     Application provision for the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2024  
           SCHEDULE 1 Powers of the Minister under the Act