Therapeutic Products Regulatory Scheme consultation

Submissions close 5.00 pm, Thursday 18 April 2019.

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.

How to have your say

The closing date for submissions is 5.00 pm, Thursday 18 April 2019.

Submissions can be made via our online consultation tool.

The Ministry’s preference is to receive submissions via the consultation tool. If you are unable to make a submission using this consultation tool, you can send in an electronic submission. It would assist our analysis if you aligned your responses to the consultation questions as much as possible. Please ensure you complete the submitter profile form and send in via email with your submission.

Email your completed submission and submitter profile form to therapeuticproducts@moh.govt.nz. Note, your submission may be requested under the Official Information Act 1982. If this happens, the Ministry will normally release your submission to the person who asks for it. If you consider there are good reasons under the Official Information Act 1982 to withhold it, please clearly indicate these in your submission.

Information forum

In February, we will be holding an information forum to explain the Bill. The focus of this forum is not to collect feedback on the Bill, but 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. If you are interested in attending this information forum please register your interest.

Sector forums

In March we will be holding a number of forums for particular sector groups. The purpose of these forums is to explain the aspects of the Bill that are particularly relevant to a particular sector and to seek feedback. If you are interested in attending one of these forums please register your interest.

The Government’s decisions relating to release of the draft of the Therapeutic Products Bill and consultation document are available in the Cabinet paper and Regulatory Impact Summary, downloadable from the Therapeutic products regulatory regime page.

Privacy

We may publish submissions on the Ministry's website, unless you have asked us not to. If you are submitting as an individual, we will automatically remove your personal details and any identifiable information. You can chose to have your personal details withheld if your submission is requested under the Official Information Act.

Publishing information

  • Date of publication:
    14 December 2018
  • ISBN:
    978-1-98-856830-0 (online)
  • HP number:
    6992
  • 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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