Review of the regulation of products at the interface between cosmetics and therapeutic goods
Consultation
March 2005
This document was released in March 2005 for comment. It remains on this website as a historical reference.
The following letter was sent to stakeholders on 18 March 2005.
Dear stakeholder
On 3 May 2004 your involvement was invited in a review of the policy framework for regulating products at the cosmetic / therapeutic interface that is being conducted jointly by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Non-prescription Medicines Branch of the Therapeutic Goods Administration (TGA).
The review is intended to address the interface issues identified in the Final report and recommendations for NICNAS Low Regulatory Concern Chemicals Reform Initiative as well as separate proposals from the Australian cosmetic industry to the TGA that certain sunscreens should be regulated as cosmetics. Because this examination of the cosmetic/therapeutic interface has implications for the regulatory approach for therapeutic products adopted under the joint trans-Tasman regulatory scheme that will commence operation in mid 2006, the review also examined the regulation of certain therapeutic products under the joint agency.
Following extensive consultation in Australia and New Zealand, the outcome of the review has now been released as draft discussion paper that will be open for comment before a final report is published. A copy of this document is enclosed and is also available on the TGA, Joint Agency and NICNAS websites.
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
In developing options for reform the intention is to undertake an open and consultative process. Comments can be submitted to cosmetic_review@nicnas.gov.au.
Contents
- Abbreviations
- Acknowledgments
- Terms of reference
- Summary
- Recommendations
- Introduction
- Overview of the regulation of medicines and cosmetics in Australia and New Zealand
- Overview of the regulation of medicines and cosmetics in other countries
- Regulation of product categories under the joint regulatory scheme for therapeutic products
- Appendix 1 - Definitions
- Appendix 2 - NICNAS Low Regulatory Concern Chemicals (LRCC) reform
