Commonwealth Numbered Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES -- COST RECOVERY) REGULATIONS 2009 (SLI NO 372 OF 2009)

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.1.    Name of Regulations  
   1.2.    Commencement  
   1.3.    Definitions  

   PART 2--APPLICATIONS

           Division 2.1--Evaluation categories for applications etc

              Subdivision 1--Preliminary

   2.1.    Scope of applications  
   2.2.    Categories of applications  

              Subdivision 2--Applications that are major

   2.3.    Major -- applications to list  
   2.4.    Major -- health advantage test  
   2.5.    Applications excluded from major category  
   2.6.    Requirements for major applications  

              Subdivision 3--Applications that are minor

   2.7.    Minor -- applications to change listings  
   2.8.    Minor -- clinical need and effectiveness test  
   2.9.    Minor -- exceptions to new brand of existing pharmaceutical item category  
   2.10.   Minor -- applications that are resubmissions  
   2.11.   Minor -- medicinal foods  

              Subdivision 4--Other categories

   2.12.   Applications that are Committee Secretariat  
   2.13.   Committee Secretariat -- exceptions to new brand of existing pharmaceutical item category  
   2.14.   Applications that are new brand of existing pharmaceutical item  

              Subdivision 5--Evaluation categories

   2.15.   Matters requiring consideration  

           Division 2.2--Application procedure

   2.16.   How to apply  
   2.17.   Notification  
   2.18.   Assessment of applications  
   2.19.   Withdrawal of application  
   2.20.   Resubmission of applications  

           Division 3.1--Pricing

   3.1.    Applications to which this Part applies  

           Division 3.2--Pricing categories for applications

   3.2.    Pricing categories  
   3.3.    Complex pricing category  
   3.4.    Simple pricing category  
   3.5.    Pricing Secretariat pricing category  
   3.6.    Claims of cost minimisation  

           Division 3.3--Pricing procedure

   3.7.    When a pricing fee is payable  
   3.8.    Notification  

   PART 4--FEES

   4.1.    Evaluation fees  
   4.2.    Pricing fees  
   4.3.    Independent review fee  
   4.4.    Payment of fees  
   4.5.    Delay in payment of evaluation fee  
   4.6.    Delay in payment of pricing fee  
   4.7.    Indexation of fees  

   PART 5--EXEMPTIONS AND WAIVERS

   5.1.    Exemptions  
   5.2.    Waiver of fees  

   PART 6--REVIEW OF DECISIONS

   6.1.    Notice of review rights  
   6.2.    Internal review  
   6.3.    Internal review -- Secretary  
   6.4.    Fee adjustment  
   6.5.    Review by Administrative Appeals Tribunal  

   PART 7--APPLICATION PROVISION

   7.1.    Application of these Regulations  
           SCHEDULE 1 Applications
           SCHEDULE 2 Medicinal preparations
           SCHEDULE 3 Evaluation fees
           SCHEDULE 4 Pricing fees