New Zealand Regulatory Impact Statement on a proposal for a trans Tasman agency to regulate therapeutic products
November 2002
Contents of document
- Problem definition
- Pharmaceuticals
- Complementary medicines
- Medical devices
- Magnitude of risk
- Trans-Tasman Mutual Recognition Arrangement (TTMRA)
- Public policy objectives
- Health objectives
- Wider objectives
- Feasible options
- Non-regulatory options
- Regulatory options
- Options for resolving the existing special exemption under the Trans-Tasman Mutual Recognition Arrangement
- Net benefit of the proposal
- Consultation undertaken
- Business compliance cost statement
- Sources of compliance costs
- The parties likely to be affected
- Compliance cost spread for the complementary medicines sector
- Incremental compliance costs
- Risks associated with estimates
- Key issues identified in consultation
- Overlapping compliance requirements with other agencies
- Steps to minimise compliance costs