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Proposed changes to the sunscreens section of the ARGOM

Consultation

5 May 2010

This consultation closed on 18 June 2010

Invitation to comment

The Therapeutic Goods Administration (TGA) sought comments from interested parties on proposed revisions to guidelines on sunscreens in the Australian Regulatory Guidelines for OTC (Over the Counter) Medicines (ARGOM).

These revisions will provide a complete, clear and single source of information on Australian requirements for sunscreen regulated as therapeutic goods, and will replace the current chapter 10 'Sunscreens' in the ARGOM.

The TGA hopes the consultation process will assist in improving the ARGOM chapter on sunscreens and make it clear and useful for its intended audience when published.

Timetable

Document released for consultation 5 May 2010.

Interested parties responded by close of business Friday 18 June 2010.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

This consultation is a component of the TGA's ongoing ARGOM-09 project to review and update the ARGOM.

ARGOM chapter 10 has been substantially revised, updated and expanded by a working group composed of representatives of the TGA, the National Industrial Chemicals Notifications and Assessment Scheme (NICNAS), and the Australian pharmaceutical and cosmetics industries. The resulting draft brings together all of the Australian requirements for sunscreens regulated as therapeutic goods that to date have been located in several different documents available from a variety of sources. The revised chapter is designed to provide more complete and clearer guidance as a single source of information for manufacturers and distributors of sunscreens to be marketed in Australia.

This consultation represents the final step in the revision process and gives interested parties the opportunity to help refine the document before it is finalised.

Content of submissions

Submissions may address any, or all, of the proposed amendments to ARGOM Chapter 10 and other identified issues.

In addition, your submission might include:

  • Suggested improvements
  • Whether or not you support the revised chapter
  • An assessment of how the revised chapter will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

Submissions will be acknowledged.

Submissions will be considered and the draft amended where necessary before being presented to the Advisory Committee on Non-prescription Medicines (ACNM) for endorsement.

Feedback will be provided to respondents through the publication on the TGA's Internet site of the ACNM recommendations.

Respondents should not assume however that recommendations made by the ACNM will reflect the final decision of the TGA relating to any amendment to the ARGOM.

Confidentiality

All submissions will be placed on the TGA's website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

More information

The TGA invited comments on the draft document from the following organisations:

  • Australian Self-Medication Industry Inc. (ASMI)
  • ACCORD Australasia Limited.

Stakeholders were able to forward comments to one of those organisations for incorporation into its response or to send comments directly to the TGA.

Any questions relating to submissions should be directed to the project officer by email to otc.medicines@tga.gov.au or by telephone to 1800 020 653.

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