Regulatory impact statement
Publication Date:
28 April 2016
Previous Cabinet decisions have directed analysis towards consideration of a more enabling regulatory environment and lean principles-based primary legislation (SOC-15-MIN-0050 and SOC-15-MIN-0049 refer). Cabinet has agreed strategic policy and key elements for the regulatory regime. This RIS is focussed on:
- clinical trials
- cell and tissue therapeutic product regulation
- prescribing and dispensing
- pharmacy licensing
- import and export
- offences and penalties framework
- regulator form
- interface with the Hazardous Substances and New Organisms Act.