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Submissions, Discussion documents and Links etc

 

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Short of time but want to know what this is all about?
Read this BRIEF OVERVIEW of what has happened so far

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Indicates Recommended reading

3rd Aug 2009

Please find link to discussion document regarding the latest round of consultation on mandatory fortification of bread with folic acid:

www.nzfsa.govt.nz/consultation.

Please feel free to pass this email on to anyone in your organisation who you feel may be interested in making a submission.  Submissions close on 12 August 2009.
The Government is aware that there is significant public interest in this issue and has decided to consult on three options relating to the fortification of bread with folic acid.

The Government’s preferred option is to amend the New Zealand (Mandatory Fortification of Bread with Folic Acid) Food Standard to delay its commencement until 31 May 2012. A deferred commencement date would for allow for the planned 2011 review of the Australian standard to be completed. The outcome of this review would provide valuable information for the Minister to drawn on to decide how to proceed at that time.

As the mandatory standard is due to commence on 27 September 2009, the timeframe in which consultation can occur is very short. We appreciate the difficulties that the short timeframe may cause some submitters but it is important that any decisions are made before the current commencement date. All submissions will be given full consideration before making a final decision. 

Yours sincerely

Carole Inkster
Director, Policy

New Zealand Food Safety Authority
7th May 2009 recommended

Click here
"Proposed Natural and Traditional Health Products Bill"

44 page PDF

Click here for "Executive Summary"
2 page PDF

28th Oct 2008 New Zealand Food (Supplemented Food) Standard 2008
A submission made jointly by the Submitters:
New Zealand Health Trust ("NZHT") and
New Health New Zealand Incorporated ("New Health")
click here for 10 page PDF
1st Aug 2008

The New Zealand Food Safety Authority is proposing to update the regulations surrounding food-type dietary supplements. The proposed changes will bring the laws surrounding the manufacture and sale of these food-type dietary supplements into line with the Australia New Zealand Food Standards Code.

New rules proposed for food-type dietary supplements
http://www.nzfsa.govt.nz/publications/media-releases/2008/2008-08-01-supplemented-food-standard.htm

Proposed changes to the dietary supplement regulations
http://www.nzfsa.govt.nz/policy-law/consultation/supplemented-food/

Proposed Standard for Supplemented Food
http://www.nzfsa.govt.nz/policy-law/consultation/supplemented-food/discussion-doc/index.htm

Draft New Zealand Food (Supplemented Food) Standard 2008
http://www.nzfsa.govt.nz/policy-law/consultation/supplemented-food/draft-standard/index.htm

The Addition of Vitamins and Minerals to Food-type Dietary Supplements http://www.nzfsa.govt.nz/policy-law/consultation/supplemented-food/vitamins-minerals/index.htm

30th Apr 2008

Public Health Bill

2nd oral submission to the Health Select Committee re the Public Health Bill in AK by NZ Health Trust Click here for the PDF

1st written submission to the Health Select Committee re the Public Health Bill by NZ Health Trust click here for the PDF

Public Health Bill click here for the PDF 4MB - Feb 2008
visit the website below.
http://www.legislation.govt.nz/bill/government/2007/0177-1/latest/versions.aspx

Original July 1998 public health Bill discussion document click here

Dec 2007

Proposed Changes to the Regulation of Dietary Supplements

Visit NZFSA wbsite
click here to download the NZFSA proposal info in PDF
click here to download the PDF document from Medsafe letter advising of changes

information from Medsafes website to the above proposed changes

Dietary Supplement Regulations 1985 click here to read the regulations PDF

Medicines Act 1981 click here to read the Act

The review of fees payable under the Medicines Act 1981 and the Misuse of Drugs Act 1975 has been completed.  See below for documents relating to the fees review. 
The revised schedule of fees is effective from 21 August 2006 click here

or use these two direct links below to the relevant info pages

  1. Revised schedule of application fees for consent, applying to the various types of applications and notifications (effective from 21 August 2006) click here
  2. Schedule of New Fees for all Licences under the Medicines Act 1981
    and the Misuse of Drugs Act 1975 click here

 

 

28th June 2007

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration (FDA) Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

click here to read the 815 page PDF or right click and save target as to download it

15th June 2007
recommended reading

Minority report by Green party

We oppose the bill because we believe it will reduce New Zealander’s access to many dietary supplements and traditional medicines, reduce consumer choice, increase compliance costs of natural health products and result in the closure of many small New Zealand businesses. We also have serious constitutional concerns with the proposed regulatory regime, which we believe will undermine the sovereignty of our Parliament. read the PDF

15th June 2007
recommended reading

Therapeutic Products and Medicines Bill (103-1) (15 June 2007)

The Government Administration Committee has examined the Therapeutic Products and Medicines Bill. We have been unable to reach agreement and therefore cannot recommend that the bill be passed.

Govt Admin Committee report released today click here for the PDF

23 Feb 2007

NZFSA Discussion Document

NZFSA now wants to progress the development of new regulations to cover complementary foods and has produced a new discussion paper called
Proposed Changes to the Regulation of Dietary Supplements (pdf, 107KB 21 Pages) which explains how the new regulations might work.

Visit NZFSA website page for all info

The closing date for submissions is Wednesday, 29 March 2007.

Please send your submission to:
Trish Ranstead, Policy Group
New Zealand Food Safety Authority
PO Box 2835, Wellington – New Zealand
Facsimile: (04) 463 2583
Email: policy@nzfsa.govt.nz

 

7th Feb 2007

7th Feb 07 -Therapeutic Products and Medicines Bill submission from NZ Health Trust / New Health NZ presented to the Government Administration Committee.
NZ Health Trust / New Health NZ Submission 1 PDF 26 pages 141k

29 Jan 2007

29 Jan 07 - NZ Health Trust summary of the key provisions of the Therapeutic Products and Medicines bill tabled Dec 2006 and its likely effects
Click here PDF of the main points - 8 pages

Dec 2006

The Government Administration Committee is inviting public submissions on the Therapeutic Products and Medicines Bill. Dec 2006

The closing date for submissions is Wednesday, 7 February 2007.
[Note: Submissions must be recieved by the committee by Wed 7th February 2007.]

Click here for The Bill PDF10771K (warning 494 pages.)
Options: Left click the link to view in Browser or Print.
Or Right click the link and "Save Target As" To save the PDF to your hard drive

Address your submission to:

Clerk of the Committee
Government Administration Committee
Select Committee Office
Parliament Buildings
WELLINGTON


The committee requires 2 copies of each submission. Those wishing to include any information of a private or personal nature in a submission should first discuss this with the clerk of the committee, as submissions are usually released to the public by the committee. Those wishing to appear before the committee to speak to their submissions should state this clearly and provide a daytime telephone contact number.
For further guidance read
Making a Submission to a Parliamentary Select Committee [PDF 177k]

Government website links

  1. The Therapeutic Products and Medicines Bill government webpage
  2. The Select Commitee submissions called for page



23 May 2006

Draft ANZTPA Rules
Consultation documents released

23 May 2006

Documents detailing the proposed joint regulatory scheme for the new Australia New Zealand Therapeutic Products Authority (ANZTPA) have been released for public consultation.

Submissions are being welcomed on the proposed regulatory scheme or "draft Rules" for medicines and medical devices; a description of the proposed Grouping Order for medicines; draft guidelines on transition provisions for product licensing; the key components of the draft Administration Rule; and the consultation document on the proposed fees and charges.

The closing date for submissions on the consultation documents is 15 August 2006.

For more information go to Govt website ;
 http://www.anztpa.org.nz/consult/consdocs1.htm

April 2006

REPORT BY OCEANIA HEALTH CONSULTING
January 2005

REVIEW OF THE NEED FOR FURTHER REGULATION OF EXTEMPORANEOUS COMPOUNDING.

See item 2 The present legislative Framework in Australia and 2.1 Constitutional Limitations of the Therapeutic Goods Act, of this report showing a very real example of why the TGA is so keen for the trans tasman body - nothing to do with NZ - more about removing their constitutional inability to regulate sole traders and natural persons.

This report demonstrates that the TGA wants to extend its control to all Territories and states to cover natural people and reach into pharmacists and hospital controls, all of which are currently outside their domain.

(Only currently covers 3 of the 8 being NSW, Tasmania, but to a lesser degree Victoria)
Read the PDF by clicking here 31 pages

5th May 2006

Complementary and alternative medicines (including traditional Māori treatments) used by presenters to an emergency department in New Zealand: a survey of prevalence and toxicity

Tonia Nicholson

5,880 presentations at Waikato A&E and not a single presentation due  to Complementary medicines...!

"Additionally, during the relatively short period over which this study was conducted (7 weeks) there were no presentations to the Emergency Department with adverse effects associated with the use of  CAM."

http://www.nzma.org.nz/journal/119-1233/1954/

SO WHERE IS THE PROBLEM AND WHY IS LABOUR PUSHING SO DESPERATLY FOR TGA/ANZTPA??

 

TRADING HEALTH CARE AWAY?
GATS, Public Services and Privatisation
By CORNER HOUSE
click here for the 36 pages PDF or click here to read it on the web page
They provide very readable explanations of the international developments.

Dec 2005

Summary of Concerns
BASIS FOR THE NZ HEALTH TRUST’S OPPOSITION TO THE TRANS TASMAN THERAPEUTIC GOODS REGULATOR?
While there many issues involved, the opposition to the Government proposals to hand control of all therapeutic products to a single Trans Tasman regulator can be summarized into three major concerns: download the pdf for full story

Dec 2005

Regulation of Non-prescription Medicinal Products

No. 18

Year: 2004/2005
Tabled: Thursday, 16th December 2004
Audit Type: Performance Audit
Agency: Department of Health and Ageing
Theme: Legislative and/or Administrative Compliance

Summary
The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing, is responsible for the regulation of the manufacture and supply of therapeutic goods. The objective of the audit was to assess the TGA's regulation of non-prescription medicinal products. In particular, it reviewed the TGA's systems, procedures and resource management processes used to approve new manufacturers, monitor ongoing manufacturer and product compliance with mandated requirements, and manage non-compliance. The audit made 26 recommendations designed to improve the transparency, quality and reliability of regulatory decisions taken by the TGA and improve its accountability mechanisms by enhancing its management information systems.


Available downloads:

Audit Report 18 (Adobe PDF 830Kb)
Audit Brochure 18 (Adobe PDF 128Kb)

Oct 2005

AUSTRALIAN SENATE INQURY UPDATE
The Australian Senate Inquiry into the TGA Amendment Bill 2005 has been extended to 7th November 05, there are still a few days to make your submission.  This Bill will make the draconian TGA penalties even worse and take them to a level that could destroy most natural health businesses.  It will give the TGA more power than ever before.

Oct 2005

To view Mike Browning's work on the "What's wrong with the TGA Bill pdf" click here and the "Draconian Fines pdf" click here.

May 2005

TGA proposed fees & charges increase
The TGA have announced that their already heavy fees are to be increased again on 1 July this year.  Plus, they claim that the complementary medicines sector has been under charged for its share of costs by about 11%.  This gives a clear picture of where the fees are heading and what NZ businesses could expect under the proposed joint regime.

March 2005

Australian Government response to the recommendations of the Expert Committee on Complementary Medicines in the Health System

March 2005

Australian Government
Industry Briefing Reg Issues Bill 2005

28th June 2005

 

 

28th June 2005

 

 

 

March 2005

A report by NZ Health Trust on the Australian Therapeutic Goods Amendment Bill 2005

The Amendment Bill is currently set to be introduced to the Australian Parliament and if passed would bring into force a regime of penalties and enforcement actions which would give the TGA unheralded and almost unbridled power. read more on PDF...


How The Bill Would Increase Penalties for Natural Medicines (Natural Health Products)
Click here to view A table of existing and propsed penalties relating to Natural Medicines by Mike Browning - this has not been checked by NZHT, however if you read the PDF below you will see the penalty units associated to each offence. 1 penalty unit = AU$110


Australian Government Therapeutic Goods Amendment Bill 2005
(107 Pages)

18 Dec 2004

Public Consultation on Draft Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes

Date of publication: December 2004
NZ Gov (MOH) Click Here
Aust Gov (NHMRC) Click Here
Timeframe for consultation
The consultation period commenced on 18 December 2004 and will close at 5pm 18 March 2005 .

This project to revise and develop Nutrient Reference Values (NRVs) has been managed by the National Health and Medical Research Council of Australia (NHMRC), in partnership with the New Zealand Ministry of Health and is the first of its kind.

You can download four documents:
1. Consultation letter (PDF, 64kB)
2. Executive summary (PDF, 437 kB)
3. Full document (PDF, 1.29MB)
4. Evidence Appendix (PDF, 1.1MB)

17 Dec 2004

Definitions Consultations Paper
(Produced by Medsafe & TGA ) Proposed regulatory definitions for complementary medicines and homoeopathic medicines in joint Australia New Zealand Therapeutic Products Agency.
Deadline for Submissions
The deadline for receipt of submissions is
close of business friday 11th March 2005

17 Dec 2004

Homeopathic Review Consultation Paper
(Produced by Med safe & TGA ) Regulation of Homoeopathic and related medicines in a joint Australian New Zealand Therapeutic Products Agency
Deadline for Submissions
The deadline for receipt of submissions is close of business friday 11th March 2005

17 Dec 2004

Herbal Regulation Consultation Paper
(Produced by Medsafe & TGA )
This paper outlines how herbal substances are currentl?y regulated in New Zealand and Australia and examines problems that have emerged under the existing regulations. A key aim of this paper is to seek comments on the mechanisms proposed to address these problems and the impact such changes may have on the stakeholders.
Deadline for Submissions
The deadline for receipt of submissions is close of business friday 11th March 2005

26 Oct 2004

Just how close should Australia & New Zealand get?
Closer Economic Relations (CER) is put on notice

Amy Adams, Simon Mortlock Partners & New Zealand Health Trust Speech to the 14th National Health Summit , Sydney 26 October 2004

Oct 2004

NEWSMONITOR transcript 91814 27th Oct 2004
Mai Chen interview by Linda Clark on the draft report of the Australian Productivity Commission

24 Oct 2004

Australian Government Productivity Commission
Australian and New Zealand Competition and Consumer Protection Regimes - Draft Research Report

Sep 2004

NZHT response to the Governments response to Report of the Health Select Committee below

Sep 2004

Government Response to Report of the Health Committee on International treaty examination of the Agreement between the Government of New Zealand and the Government of Australia for the establishment of a joint scheme for the regulation of therapeutic products, presented to the House of Representatives in accordance with Standing Orders 251. A.5

Sep 2004

Draft Australia New Zealand therapeutic products advertising code September 2004 Version 10

Sep 2004

NZHT submission on proposed changes to the Dietary supplements regulations 1985 Paper no 01/04

Aug 2004

Ministerial Advisory Committee on Complementary and Alternative Health (MACCAH), forms the Committee's final advice to the Minister of Health, Annette King

Jul 2004

NZFSA Public Discussion Paper no 01/04 July 2004. Proposed Changes to the Dietary Supplements Regulations 1985

Jun 2004

Health Select Committee report released 18th June 2004 on the treaty between New Zealand and Australia.
Agreement between the Government of New Zealand and the Government of Australia for the establishment of a Joint Scheme for the Regulation of Therapeutic Products
(As reported by the Health committee)
( Date Presented: 18/6/2004 (pdf, 330 kb)

Jun 2004

A Presentation by NZHT to the Canterbury and Nelson Nutraceutical Cluster regarding consequences of the JTA and alternate regulatory model.

May 2004

3rd Submission to Health Select Committee on Treaty

Apr 2004

Submission to Health Select Committee on Treaty Medsafe - oral in response to the presentation by the Ministry of Health, Medsafe and Ministry of Foreign Affairs and Trade.

Apr 2004

New Zealand National Interest Analysis on the Agreement Between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products

Mar 2004

NZHT Briefing submission on Treaty.

Mar 2004

National Interest Analysis Text of the Proposed Treaty Action

Mar 2004

Australian "Regulation Impact Statement"

Mar 2004

Signup form for the newsletter and business directory.

Feb 2004

A5 Government Response to Report of the Health Committee on Inquiry into the Proposal to Establish a Trans -Tasman Agency to Regulate Therapeutic Products.

Dec 2003

MOH Annette King (NZ) and Trish Worth (AU) Treaty Signed between NZ & Australia.

Dec 2003

Report of the Health Select Committee
Inquiry into the proposal to establish a Trans-Tasman Agency to regulate Therapeutic products.

Nov 2003

"Investigate" Magazine - article

Sep 2003

NZHT Proposed Model for the Regulation of Dietary Supplements in New Zealand - Synopsis
"A synopsis of the alternative model for regulation.  This model is not presented as a final form of regulation but has been developed to show that better systems of regulation are viable.  Clearly any final form of regulation would need a significant amount of detail which would have to developed in conjunction with the regulators.  The work we have done is instead intended to show that a risk based, New Zealand system of regulation, specific to NHP's can be achieved at a level of cost that would be acceptable to business."

Sep 2003

New Zealand Regulatory Impact Statement

Jul 2003

NZHT response to the TGA - Medsafe - EU submission on the MOH/Medsafe Discussion Document.

May 2003

Economist-Phil Donnelly opinion of NZIER report.

Apr 2003

NZHT Public Health Submission to the Ministry of Health on the Public Health Legislation: Promoting public health, preventing ill health and managing communicable diseases, Discussion Paper made by The New Zealand Health Trust.

Mar 2003

Ministry Of Health Public Health discussion document.

Nov 2002

Submission from the Dietary Supplements Consultative Group to MOH Medsafe Discussion Document.

Oct 2002

Assessment of Regulatory Options for Therapeutic Products - Report to the trans-Tasman working group
The NZ Institute of Ecconomic Research (Inc)

Jun 2002

NZHT Submission to MOH Medsafe Discussion Document.

Jun 2002

MOH/Medsafe Discussion Document.
1985

Dietary Supplement Regulations 1985

Complementary Medicines links

1981

Medicines Act 1981 click here to read the legislation

The review of fees payable under the Medicines Act 1981 and the Misuse of Drugs Act 1975 has been completed.  See below for documents relating to the fees review. 
The revised schedule of fees is effective from 21 August 2006 click here

or use these two direct links below to the relevant info pages

  1. Revised schedule of application fees for consent, applying to the various types of applications and notifications (effective from 21 August 2006) click here
  2. Schedule of New Fees for all Licences under the Medicines Act 1981
    and the Misuse of Drugs Act 1975 click here