DOSAGE & ADMINISTRATION SECTION
Dosage Form Lotion Route of Administration Topical
The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept. The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request. Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor. The following two conditions apply where testing conducted by AMA Laboratories Inc. is used to substantiate compliance of the product with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products - Evaluation and classification (the Sunscreen Standard): a) The sponsor is required to hold adequate supplementary in-vitro testing data and/or relevant testing data from an independent testing laboratory on a comparable formulation, or other justification acceptable to the TGA, to scientifically justify the validity and accuracy of the SPF, broad spectrum and water resistance claims for the product. b) The sponsor must provide the data, documentation or other justification to the TGA within 10 working days of a request by the TGA, or as deemed reasonable by the delegate upon request.
