The Therapeutic Goods Administration (TGA) has posted guidance for sponsors planning to change a registered over-the-counter (OTC) medicine.
The posting includes the OTC Changes table, which is a tool to help sponsors obtain essential regulatory information about their changes, as well as explaining how to use the table.
ARTG records cannot be changed without prior approval, the TGA said, and reminds sponsors to contact the TGA on 1800 020 653.
Visit www.tga.gov.au for more.
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