Source: https://www.legislation.gov.au/Details/F2016C00622
Timestamp: 2020-07-11 08:51:21
Document Index: 217925352

Matched Legal Cases: ['art 3', 'art 7', 'art 2', 'art 3', 'art 5', 'art 6', 'art 7', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5']

Details: F2016C00622
- F2016C00622
SLI 2009 No. 372 Regulations as amended, taking into account amendments up to Biosecurity (Consequential Amendments and Transitional Provisions) Regulation 2016
sch 2, item 25
F2016C00622
Part 3—Pricing
Part 7—Application provision
Schedule 3—Evaluation fees
Schedule 4—Pricing fees
This is a compilation of the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009 that shows the text of the law as amended and in force on 16 June 2016 (the compilation date).
Part 2—Applications 2
Division 2.1—Evaluation categories for applications etc 2
Subdivision 1—Preliminary 2
2.1......... Scope of applications.......................................................................... 2
2.2......... Categories of applications................................................................... 2
Subdivision 2—Applications that are major 2
2.3......... Major—applications to list.................................................................. 2
2.4......... Major—health advantage test.............................................................. 2
2.5......... Applications excluded from major category........................................ 3
2.6......... Requirements for major applications................................................... 3
Subdivision 3—Applications that are minor 3
2.7......... Minor—applications to change listings............................................... 3
2.8......... Minor—clinical need and effectiveness test........................................ 4
2.9......... Minor—exceptions to new brand of existing pharmaceutical item category 4
2.10....... Minor—applications that are resubmissions....................................... 4
2.11....... Minor—medicinal foods..................................................................... 5
Subdivision 4—Other categories 5
2.12....... Applications that are Committee Secretariat........................................ 5
2.13....... Committee Secretariat—exceptions to new brand of existing pharmaceutical item category 5
2.14....... Applications that are new brand of existing pharmaceutical item........ 5
Subdivision 5—Evaluation categories 6
2.15....... Matters requiring consideration........................................................... 6
Division 2.2—Application procedure 7
2.16....... How to apply...................................................................................... 7
2.17....... Notification......................................................................................... 7
2.18....... Assessment of applications................................................................. 8
2.19....... Withdrawal of application................................................................... 8
2.20....... Resubmission of applications.............................................................. 8
Part 3—Pricing 9
Division 3.1—Pricing 9
3.1......... Applications to which this Part applies............................................... 9
Division 3.2—Pricing categories for applications 10
3.2......... Pricing categories.............................................................................. 10
3.3......... Complex pricing category................................................................. 10
3.4......... Simple pricing category..................................................................... 11
3.5......... Pricing Secretariat pricing category................................................... 11
3.6......... Claims of cost minimisation.............................................................. 11
Division 3.3—Pricing procedure 12
3.7......... When a pricing fee is payable............................................................ 12
3.8......... Notification....................................................................................... 12
4.1......... Evaluation fees.................................................................................. 13
4.2......... Pricing fees....................................................................................... 13
4.3......... Independent review fee..................................................................... 13
4.4......... Payment of fees................................................................................. 14
4.5......... Delay in payment of evaluation fee................................................... 14
4.6......... Delay in payment of pricing fee........................................................ 14
4.7......... Indexation of fees.............................................................................. 15
Part 5—Exemptions and waivers 16
5.1......... Exemptions....................................................................................... 16
5.2......... Waiver of fees................................................................................... 17
Part 6—Review of decisions 18
6.1......... Notice of review rights...................................................................... 18
6.2......... Internal review.................................................................................. 18
6.3......... Internal review—Secretary................................................................ 19
6.4......... Fee adjustment.................................................................................. 19
6.5......... Review by Administrative Appeals Tribunal.................................... 19
Part 7—Application provision 21
7.1......... Application of these Regulations....................................................... 21
Schedule 1—Applications 22
Part 1—Vaccines 22
Part 2—Pharmaceuticals 23
Part 3—Existing pharmaceutical items 25
Schedule 2—Medicinal preparations 26
Schedule 3—Evaluation fees 27
Schedule 4—Pricing fees 28
Division 2.1—Evaluation categories for applications etc
Note: See the document titled Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee, published by the Department, which can be found on the Department’s website at http://www.health.gov.au.
(i) to make a recommendation that the Minister take an action mentioned in item 1.2, 2.2, 2.5 or 2.5A in Schedule 1; or
(i) to make a recommendation that the Minister take an action mentioned in item 1.4, 2.4, 2.6, 2.8, 2.9 or 2.11 in Schedule 1; or
(1) An application that includes a request for the Committee to make a recommendation that the Minister take an action mentioned in item 1.2, 2.2, 2.5 or 2.5A in Schedule 1 is in the minor category if:
An application for the Minister to take an action mentioned in item 3.1 in Schedule 1 is in the minor category if:
(a) it is an application for the Committee to make a recommendation that the Minister take an action mentioned in item 2.7 in Schedule 1; and
(2) An application that includes a request for the Committee to make a recommendation that the Minister take an action mentioned in item 1.2, 2.2, 2.5 or 2.5A in Schedule 1 is in the Committee Secretariat category if:
An application for the Minister to take an action mentioned in item 3.1 in Schedule 1 is in the Committee Secretariat category if the application is about a kind of medicinal preparation mentioned in item 2 of the table in Schedule 2.
An application for the Minister to take an action mentioned in item 3.1 in Schedule 1 is in the new brand of existing pharmaceutical item category if the application is not about a kind of medicinal preparation mentioned in Schedule 2.
Subdivision 5—Evaluation categories
Division 2.2—Application procedure
Note: The address for the office administering the Committee can be found in the document titled Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee published by the Department. The document is available from the Department’s website at http://www.health.gov.au.
(b) be sent to the office of the Department administering applications about item 3.1 in Schedule 1.
Note: At the commencement of these Regulations, the office administering applications about item 3.1 or 3.2 in Schedule 1 is the Listings Unit in the Pharmaceutical Evaluation Branch of the Pharmaceutical Benefits Division. The address of the Listings Unit can be found on the Department’s website at http://www.health.gov.au.
(b) if the applicant requests a fee exemption or waiver under regulation 5.1 or 5.2—whether the fee exemption is granted, or the fee is waived or partially waived; and
Note: Part 4 provides for the payment of fees.
(a) the applicant may re‑submit the application in the same or an amended form; and
Division 3.1—Pricing
(iii) the Minister arranging for a price for which a designated vaccine may be supplied under section 9B of the Act.
Note: There are no fees payable under these Regulations for price agreements and determinations being made as a result of applications in the new brand of existing pharmaceutical item evaluation category.
Division 3.2—Pricing categories for applications
(b) the resulting price for a drug, medicinal preparation or vaccine is higher than the price for an equivalent amount or unit of a listed drug or a designated vaccine that:
(a) it includes a request for a review of the existing price for a listed drug or a designated vaccine and the resulting price is higher; or
(i) a claim that the effectiveness of a specified dose of a drug, medicinal preparation or vaccine the subject of the application is equivalent to the dose of a listed drug or a designated vaccine; and
(a) would provide similar health benefits to those provided by a listed drug or a designated vaccine (the other drug or vaccine); and
Division 3.3—Pricing procedure
(b) for vaccines—when a price mentioned in subparagraph 3.1 (b) (iii) is recommended.
(i) an agreement mentioned in subparagraph 3.1 (b) (i) or (iii);
(b) if a price mentioned in subparagraph 3.1 (b) (iii) is recommended—the day of the recommendation;
(d) if the applicant requests a fee exemption or waiver under Part 5 relating to a pricing fee—a decision about the request.
(b) if the applicant makes a written request to the Secretary—another period allowed by the Secretary.
Note: For example, the Department may withhold listing the drug or medicinal preparation the subject of the application on the Schedule of Pharmaceutical Benefits.
(ii) if the applicant makes a written request to the Secretary—another period allowed by the Secretary; and
(ii) if he or she revokes the decision—make any other decision he or she thinks appropriate; and
(ii) if the Secretary revokes the decision—make any other decision the Secretary thinks appropriate; and
(b) if the applicant makes an application mentioned in subregulation 6.2 (4)—paragraph 6.2 (5) (b);
16 Dec 2009 (see F2009L04013)
25 Nov 2010 (see F2010L02952)
1 Dec 2010 (see r. 2)
am. 2010 No. 294
Note to r. 3.1.............................
rs. 2010 No. 294
r. 3.4.........................................
Note to r. 4.3.............................
am. 2010 No. 294; 2011 No. 120; F2016L00717