National interest analysis on the agreement between the Government of Australia and the Government of New Zealand for the establishment of a joint scheme for the regulation of therapeutic products
March 2004
This national interest analysis was prepared by the New Zealand Ministry of Health.
Contents of this document
- Date of proposed binding treaty action
- Reasons for New Zealand to become a party to the treaty
- Background
- Pharmaceuticals
- Complementary medicines
- Medical devices
- The regulatory options
- The preferred solution
- Advantages and disadvantages to New Zealand of the treaty entering into force
- Obligations
- The joint scheme
- Key organs of the joint scheme: Agency, Ministerial Council, Board, Managing Director
- 'Instruments': Rules, Orders and Approvals
- Legislation implementing the scheme
- Accountability
- Merits review and judicial review
- Differences between Australia and New Zealand
- Funding
- Consultation, review, amendment and third parties
- Final provisions
- Economic, social, cultural and environmental effects
- Economic effects
- Social effects
- Cultural effects
- Environmental effects
- Costs
- Future protocols
- Implementation
- An illustration of how therapeutic products will be regulated under the joint scheme
- Consultation
- Pharmaceutical sector
- Medical devices sector
- Complementary medicines sector
- Consultation with Maori
- Withdrawal or denunciation