Let’s get ready for Summer! Sunscreens: are they a therapeutic good or a cosmetic?
Date - 28 November 2019
Venue - Bartier Perry
Bartier Perry in partnership with RFA Regulatory Affairs would like to invite you to our upcoming seminar.
Over the last 12 months we have seen some significant changes in the regulatory regimes responsible for the importation, manufacture, advertising and distribution of cosmetics and therapeutic goods in Australia. The recent changes highlight a fundamental difficulty that law makers and businesses alike face in trying to distinguish between therapeutic goods and cosmetics.
Depending on what side of the regulatory fence your product falls on will have vastly different implications in relation to how your product is regulated. The regulation of sunscreens provides us with a great example of the interaction between the regulatory regimes and the complexities involved in determining which regime applies.
The aim of this seminar is to give an overview of the interplay between the two regimes and some practical tips to help your business navigate its way through the recent changes and the regulatory framework generally.
Our expert panel will take you through all aspects of:
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The difference between therapeutic goods and cosmetics
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The regulatory landscape
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The interaction between the NICNAS, the TGA Act and AS 2604
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The sunsetting of the Cosmetics Standard and the introduction of the new Excluded Goods Determination
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The relevance of the Australian Consumer Law
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Tips on effectively identifying where your product falls in the current regulatory landscape
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What can happen if you get it wrong!
We are giving attendees the opportunity to submit questions or topics you would like covered during the session. Post your question when you RSVP.
Please feel free to extend this invitation to colleagues where appropriate.
Speakers
Ellie Kim - RFA Regulatory Affairs
Ellie Kim joined RFA Regulatory Affairs in 2012 and is now Regulatory Affairs Manager. Ellie and her team have developed and implemented regulatory compliance programs for a range of cosmetic companies, making submissions and reporting to NICNAS, the Australian regulatory agency.
They have also submitted numerous applications to the Therapeutic Goods Administration (TGA) for complementary medicines and sunscreens, and advised international and local companies on compliance with food regulations.
The technical team works with companies to ensure company-wide compliance, undertaking comprehensive reviews of product formulations and preparing compliant labels while keeping current with continuously evolving regulatory requirements.
Michael Cossetto - Bartier Perry
Michael is the Head of the Corporate & Commercial Group at Bartier Perry. He has more than 20 years’ experience acting for private businesses, not-for-profits and government bodies across a range of corporate and commercial legal transactions. disclosure of personal information.
Over the years, Michael has acquired specialist knowledge in the areas of Contract Law, Consumer Law, Intellectual Property, Information Technology, Data protection and Privacy. His practice is focused on the FMCG and IT industries. He acts for several pharmaceutical and cosmetic businesses.