Therapeutic Products Regulatory Scheme consultation

Submissions on this consultation have now closed.

Published online: 
14 December 2018
Therapeutic Products Regulatory Scheme: Consultation document.

The Ministry of Health is seeking feedback on the draft of Therapeutic Products Bill. The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. This includes medicines (including cell and tissue products) and medical devices. Natural Health Products (including rongoā Māori) will be excluded, as far as possible, as the Government is considering options for how these could be regulated as a separate process.

Recognising the complexity of the Bill, and the impact of the holiday period, the consultation period will run for four months, ending 18 April 2019.

The Bill can also be viewed online at the Parliamentary Counsel Office website.

Accompanying the Bill is the Therapeutic Products Regulatory Scheme: Consultation document. The purpose of this consultation document is to help you to understand the draft Therapeutic Products Bill and to seek feedback on the provisions and key policy matters in the Bill.

The design of the consultation document is intended to allow you to easily find the topics of interest to you and cater to differing levels of interest. The consultation document is divided into three main chapters:

  • Chapter A: Key features of the new regulatory scheme – this chapter describes the rationale for the Bill, what products it covers, and the main types of controls within the regulatory scheme

  • Chapter B: Content of the draft Bill – this chapter describes the parts within the Bill, provides additional explanations on more complicated provisions, and highlights the provisions that are different from the current regulatory approach

  • Chapter C: What the new scheme would mean for different sectors or health practitioner groups – this chapter explains what the new regulatory scheme would mean for the main sectors and health practitioner groups and highlights particular policy matters of interest. It includes a section for consumers/patients (including the disability sector) that focuses on those policy matters likely to be most relevant from their perspective.

Consultation period is closed

Submissions closed at 5.00 pm, Thursday 18 April 2019.

Information forum

The Ministry held an information session to explain the draft Bill on 11 February. The focus of the session was to help those with an in-depth interest in the technical aspects of the new regulatory scheme to understand how the provisions in the draft Bill work.

The presentation, including an audio recording of the presentation, from this information session are available below

View presentation video featuring slides and audio

Listen to audio-only version of the presentation

Download audio-only version of the presentation (1 hr 14 minutes, mp3, 30 MB)

Information session slides (pptx, 486 KB)

Download a summary of the information session question and answers (Word, 17 KB)

Sector forums

In March the Ministry of Health held consultation forums on the draft Therapeutic Products Bill with the following sector groups: Medicines, Medical Device, Cell and Tissue, Research, Pharmacy, Consumers, and Health Practitioners. The Ministry also held a forum in Christchurch covering the draft Bill more generally. We would like to thank the stakeholders that attended these forums for their engagement and thoughtful questions. The questions and comments raised during these forums will be considered as part of the consultation analysis.

The presentations from these forums are available below.

Publishing information

  • Date of publication:
    14 December 2018
  • ISBN:
    978-1-98-856830-0 (online)
  • HP number:
  • Citation:
    Ministry of Health. 2018. Therapeutic Products Regulatory Scheme: Consultation document. Wellington: Ministry of Health.
  • Ordering information:
    Only soft copy available to download
  • Copyright status:
    Owned by the Ministry of Health and licensed for reuse under a Creative Commons Attribution 4.0 International Licence.
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