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128 results

  • Update to the Guideline on the Regulation of Therapeutic Products – Part 11: Clinical trials

    This consultation is aimed at pharmaceutical companies, health care professional organisations, and individuals involved in conducting, or who are subjects of, clinical trials of medicines. Medsafe sought comment on a major revision of the Guideline on the Regulation of Therapeutic Products in New Zealand. Part 11: Clinical trials – regulatory approval and good clinical practice requirements. Part 11 of the regulatory guideline was last reviewed in January 2015. Since then,... More
    Closed 10 August 2018
  • Proposed changes to the National Health Index (NHI) system and HISO 10046, the Consumer Health Identity Standard

    The Ministry of Health is considering undertaking a number of changes to the National Health Index (NHI) system. Changes made will be included in the associated Consumer Health Identity Standard . We seek comment to assist in establishing a) if a particular proposal should proceed at a concept level, and b) a relative priority for each proposal. Some changes are essential to maintaining the operating life of the NHI system – for example, the proposed extension to the NHI numbering... More
    Closed 24 August 2018
  • Posthumous Reproduction: A review of the current Guidelines for the Storage, Use, and Disposal of Sperm from a Deceased Man to take into account gametes and embryos

    Posthumous reproduction involves the use of a person’s sperm or eggs, after their death. In some cases, it also involves the retrieval of these gametes very shortly after death or at a time when death is imminent. While scientific advances have made this form of reproduction possible, there are many complex ethical and legal issues that have not yet been resolved. For example, the existing Guidelines, written in 2000 apply only to the posthumous use of sperm that was retrieved prior to the... More
    Closed 14 September 2018
  • Strategy to Prevent and Minimise Gambling Harm 2019/20 to 2021/22

    This document seeks your comment on the proposed future direction and content of the Ministry of Health’s Strategy to Prevent and Minimise Gambling Harm 2019/20 to 2021/22. Your feedback is vital to help us develop the final strategy. Included are draft proposals for: the strategic plan, which sets out the general strategic direction and priorities that provides a framework for the activities described below the proposed funding levels for the Ministry, in... More
    Closed 28 September 2018
  • Consultation on the Draft National Ethics Standards for Health and Disability Research

    The National Ethics Advisory Committee (NEAC) is an independent advisor to the Minister of Health. NEAC was established in 2001 by section 16 of the New Zealand Public Health and Disability Act 2000. The National Ethics Advisory Committee’s statutory functions are to: provide advice to the Minister of Health on ethical issues of national significance in respect of any health and disability matters (including research and health services) determine nationally consistent... More
    Closed 28 September 2018
  • Weight Management Tools

    This short survey will help the Ministry of Health to have a better understanding of growth and weight monitoring in New Zealand and how Practice Management Systems could assist health practitioners with this task. More
    Closed 1 October 2018
  • Proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products

    Medsafe is seeking comments on a proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products. This risk was identified by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA have received reports in which an individual using one or more paraffin-based skin product has died after their clothes and/or bedding caught fire. The MHRA published a reminder for healthcare professionals in April 2016 . ... More
    Closed 7 December 2018
  • Hearing the stories of those harmed by surgical mesh

    As part of its response to ongoing concerns with the use of surgical mesh, the Ministry of Health is wanting to provide an opportunity for people who have been harmed by surgical mesh and their families/whānau to tell their stories. It is important that any such opportunity is inclusive and supportive of people’s different needs and situations. Therefore, we would like to hear from those who are interested in telling their story, about how they would like to do this. You could be... More
    Closed 18 January 2019
  • Guidance for best practice management - National Bowel Screening Programme

    The National Bowel Screening Programme (NBSP) is a significant investment in reducing disease and death from one of New Zealand’s biggest cancer killers. The NBSP is our first screening programme for both men and women and, when fully implemented, is expected to detect 500 to 700 cancers every year, in the early stages. The development of these clinical guidelines aims to embed best practice clinical management across the screening pathway and ensure quality and consistency. More
    Closed 18 January 2019
  • Therapeutic Products Information Forum Registration

    Consultation on an exposure draft of the Therapeutic Products Bill and an associated consultation paper is underway. The Bill is intended to repeal and replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. More
    Closed 22 January 2019
  • Therapeutic Products - Events Registration of Interest

    Consultation on an exposure draft of the Therapeutic Products Bill and an associated consultation paper is underway. The Bill is intended to repeal and replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. More
    Closed 6 February 2019
  • Code of Practice for the Safe Transport of Radioactive Material

    This document sets out possible wording for a new code of practice to be issued under the Radiation Safety Act 2016 for the safe transport of radioactive material by road, rail, sea and air. The Act sets out high-level safety and security obligations in sections 9–12. There are many different types of radiation use and the requirements are often very technical. The Act therefore authorises the issuing of codes of practice to set out more detailed requirements relating to individual... More
    Closed 1 March 2019
  • Therapeutic Products Christchurch Forum Registration

    Consultation on an exposure draft of the Therapeutic Products Bill and an associated consultation paper is underway. The Bill is intended to repeal and replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. More
    Closed 14 March 2019
  • Second round of consultation on the proposed donation and surrogacy guidelines

    This is a second round of consultation, following our consultation in 2017, on ACART’s proposed changes to the guidelines for family gamete donation, embryo donation, the use of donated eggs with donated sperm (donated eggs/donated sperm) and clinic-assisted surrogacy (collectively, the Donation Guidelines review). ACART is inviting submissions on three matters it has reconsidered since the first round of consultation. Although ACART has confirmed its intention to rescind the mandatory... More
    Closed 25 March 2019
  • HISO 10072.2:2019 Bowel Screening Histology Data Standard – Draft for public comment

    You are invited to review and provide comment on the draft Bowel Screening Histology Data Standard. The National Bowel Screening Programme is a free programme for men and women aged 60–74 years eligible for publically funded health care. The primary objective of bowel screening is to reduce the mortality rate by diagnosing and treating bowel cancer at an earlier more treatable stage. A new system, called the National Screening Solution, is currently in development and will receive... More
    Closed 29 March 2019
  • Code of Practice for Industrial Radiography: Draft for consultation

    The Radiation Safety Act 2016 came fully into force on 7 March 2017. The Act is administered by the Ministry of Health’s Office of Radiation Safety. The Act sets out high-level safety and security obligations in sections 9–12. There are many different types of radiation use and the requirements are often very technical. The Act therefore authorises the issuing of codes of practice to set out more detailed requirements relating to individual areas of practice. This code relates to... More
    Closed 29 March 2019
  • Natural health products industry questionnaire

    Purpose The Ministry of Health and the Ministry for Primary Industries are asking the natural health products industry to complete this questionnaire so that we can better understand business profiles. This will help us minimise the costs and maximise the benefits as far as is practical when developing regulatory approaches, while also protecting consumers. Process If you are part of the natural health products industry, we would be grateful if you could help us by completing... More
    Closed 7 April 2019
  • Therapeutic Products Regulatory Scheme: Online Consultation

    Consultation A Therapeutic Products Bill (the Bill) is being developed to replace the Medicines Act 1981 (and its associated regulations) and establish a new regulatory scheme for therapeutic products. This consultation document is intended to be read alongside an exposure draft of the Bill. It provides information on the policy and details contained in the exposure draft to help inform submissions on the draft Bill. The purpose of this consultation document ... More
    Closed 18 April 2019
  • New Zealand Obstetric Ultrasound Guidelines

    The draft New Zealand Obstetric Ultrasound Guidelines have been developed by a working group of sector clinical experts, with support from the Ministry of Health. New Zealand Obstetric Ultrasound Guidelines: Consultation document (Word, 8.0 MB) New Zealand Obstetric Ultrasound Guidelines: Consultation document (PDF, 2.8 MB) The guidelines are a key recommendation of the Maternity Ultrasound Advisory Group, which was a sub-group of the National Maternity Monitoring... More
    Closed 3 May 2019
  • Health & Disability Workforce Strategic Priorities

    The Health Workforce directorate in the Ministry of Health is working to develop a small number of defined priorities to guide improvement actions for the New Zealand health and disability workforce during the period 2019-2024. To support this work, please fill out this survey for ranking and rating the 18 potential strategic priorities. The aim of the survey is to establish an accurate picture of people's perspectives through comparing and cross-referencing the results of the ranking... More
    Closed 31 May 2019
  • Proposed prostate cancer quality performance indicators for clinical review

    We are seeking your clinical review of proposed quality performance indicators for prostate cancer. The Ministry and the National Urological Cancer Working Group (the Working Group) have worked together to develop a set of proposed quality performance indicators (QPIs) for prostate cancer. The proposed indicators have been selected to measure performance and drive quality improvement in prostate cancer diagnosis and treatment services . The Working Group has identified a set of... More
    Closed 7 June 2019
  • Proposed Lung Cancer Quality Performance Indicators: Draft descriptions for review

    The Ministry and the National Lung Cancer Working Group (the Working Group) have worked together to develop a set of proposed quality performance indicators (QPIs) for lung cancer. The proposed indicators have been selected to measure performance and drive quality improvement in lung cancer diagnosis and treatment services . The Working Group has identified a set of 19 QPIs that measure the quality of care and outcomes for people with lung cancer in New Zealand and support continuous... More
    Closed 22 July 2019
  • Medicinal Cannabis Scheme consultation

    The Government has committed to establishing a Medicinal Cannabis Scheme to improve access to quality medicinal cannabis products through: enabling the commercial cultivation of medicinal cannabis and the manufacture of medicinal cannabis products in New Zealand setting standards for medicinal cannabis products so that medical practitioners can prescribe them with more confidence. A regulatory system, with controls on the cultivation of cannabis and the... More
    Closed 7 August 2019
  • Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

    This Medsafe consultation proposes labelling requirements for substances/groups of substances in medicines and related products that may cause an undesirable reaction (eg, allergies) in some people. Unlike foods, most medicines and related products are not required to list all the ingredients that are included in the medicine on the label. The active ingredient will always be on the medicine label, but only some inactive ingredients, also called excipients, must be on the label.... More
    Closed 8 August 2019
  • Changes to the prescribing restrictions for riluzole

    Riluzole is a glutamate agonist used in the management of amyotrophic lateral sclerosis (ALS). Riluzole is a prescription medicine approved under section 23 of the Medicines Act 1981. The following condition regarding prescriber access to this medicine applies. More
    Closed 9 August 2019
  • Code of Practice for the Security of Radioactive material: Draft for Consultation

    The Radiation Safety Act 2016 came fully into force on 7 March 2017. The Act is administered by the Ministry of Health’s Office of Radiation Safety. The Act sets out high-level safety and security obligations in sections 9–12. There are many different types of radiation use and the requirements are often very technical. The Act therefore authorises the issuing of codes of practice to set out more detailed requirements relating to individual areas of practice. This code relates to... More
    Closed 16 August 2019
  • Adult New Zealand Health Survey Stakeholder Feedback Questionnaire

    The Ministry of Health is embarking on a refresh of content in the New Zealand Health Survey (NZHS), which has been in continuous operation in its current form since 2011. The purpose of this refresh is to update NZHS content so that it better meets users' needs, while shortening the survey's length to minimise burden on respondents. This questionnaire marks the beginning of this refresh, and seeks detailed feedback from stakeholders on how useful they find the current indicators and... More
    Closed 28 August 2019
  • Child New Zealand Health Survey Stakeholder Feedback Questionnaire

    The Ministry of Health is embarking on a refresh of content in the New Zealand Health Survey (NZHS), which has been in continuous operation in its current form since 2011. The purpose of this refresh is to update NZHS content so that it better meets users' needs, while shortening the survey's length to minimise burden on respondents. This questionnaire marks the beginning of this refresh, and seeks detailed feedback from stakeholders on how useful they find the current indicators... More
    Closed 28 August 2019
  • HISO 10050.2:2019 Maternity Care Summary Standard – Draft for public comment

    To provide high quality maternity care in New Zealand we need to underpin maternity practice with information that supports the care of women, babies and their family/whānau, continuity of care, best practice, and analytics. The HISO 10050.2:2019 Maternity Care Summary Standard is designed to ensure that information related to maternity care is consistently recorded. Standardised data will enable services to be meaningfully benchmarked against each other. A meaningful data set... More
    Closed 3 September 2019
  • New Zealand Cancer Action Plan 2019–2029

    Tēnā koutou katoa, We are seeking your feedback on the New Zealand Cancer Action Plan 2019–2029 (PDF, 1.5 MB) (the Plan). The Ministry of Health has engaged with a number of cancer-sector stakeholders in the development of the Plan. The following questions about the Plan are designed to help you prepare your feedback. Not all areas of the Plan will be included in the questions as: the Ministry will or has already engaged some sections through a separate... More
    Closed 13 October 2019
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