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Review of the regulation of products at the interface between cosmetics and therapeutic goods

Consultation

17 March 2005

This document was released in March 2005 for comment. It remains on this website as a historical reference.

Letter to stakeholders

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.

How to access a pdf document

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Draft discussion paper: Review of the regulation of products at the interface between cosmetics and therapeutic goods (pdf,944kb)*

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.

Summary of responses to the recommendations

Eighty five responses were received. Respondents were asked to indicate whether they were prepared to have their submission made available on the TGA and NICNAS web sites. Eight did not wish to have their submission published - these have been included in the summary below but identifying details have been removed.

Summary of responses to the recommendations (pdf,89kb)

Submissions

The full responses are below. Seven responses have been omitted - these are the ones that did not want their submission published. The eighth respondent wished to remain anonymous but did not object to publication - this document is included but identifying details have been removed.

How to access a pdf document

*Large file warning: Attempting to open large 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.

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