Submissions close 5.00 pm, Thursday 18 April 2019.
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.