Permitted (Coded) Indications for Listed Medicines: Response to the TGA

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Permitted (Coded) Indications for Listed Medicines: Response to the TGA

Office of Complementary Medicine Unilever Australia Therapeutic Goods Administration 20 Cambridge Street PO Box 100 Epping, NSW, 2121 Woden Private Bag 2 ACT 2606 Epping, NSW 1710 Australia T: (02) 9869 6100 F: (02) 9869 6150 Email: [email protected] Dear Sir/Madam Unilever welcomes the opportunity to provide comments in regard to the TGA consultation paper on the Permitted (coded) Indications for Listed Medicines. Unilever Australia Limited trading as Unilever Australasia markets and sells products that are imported into Australia by Unilever Asia Private Limited. These products include food, home and personal care products and Unilever is a market leader across categories for foods, household and personal care products with brands such as Dove, Vaseline, Rexona, Sunsilk and Omo/Persil. Unilever manufactures a number of therapeutic products which require listing on the ARTG including disinfectants, sunscreens, medical devices and most relevant to this application, over-the-counter medicines and therefore holds an interest in this consultation document. Unilever Australia Limited is a member company of the representative industry organization, Accord and we are aligned with the comments in the Accord response to this consultation document. Unilever does not support the removal of the free text field as this is likely to negatively impact speed to market of listed medicines that do not have an indication on the current TGA list of coded indications. Unilever has identified the following indication - ‘soften and remove ear wax’ currently applicable for a Unilever listed over-the-counter product (Cerumol Oilve Oil Ear drops) which has not been included in the TGA expanded list of permitted indications. If the proposal to remove the free text option is supported enough to be progressed, then we strongly recommend TGA to include this indication on the current indications for ARTG products to ensure speed to market of future products which are designed to soften and remove ear-wax. Should you have inquiries or wish to ask for further clarification on these comments, please do not hesitate in contacting me as per the below contact details: Yours sincerely, Lucy Pearson Regulatory Affairs Executive Email: lucy.pearson@unilever,com Ph: (02) 9869 6555 .

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