This paper provides some background information and outlines the process for an exposure draft of a new Therapeutic Products Bill in 2016 which will cover:

• Medicines
• Medical devices and
• tissue and cell therapies

Part A describes why medicines (or therapeutic products) need regulating and outlines the current regulatory arrangements that establish who can prescribe and dispense prescription medicines in New Zealand.

Part B describes the new approach to legislative design followed by some early draft options concerning the regulation of prescribing and dispensing on which feedback is sought.  These proposals concern the shape of the primary legislation with respect to prescribing and dispensing.

• Draft options for regulation of prescribing and dispensing in NZ

Feedback Due: Please send feedback to marilynh@nzno.org.nz by 15 January 2016