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Australia’s TGA announced an updated process for registering over-the-counter (OTC) drugs in Australia. The instructions: ● help applicants identify the regulatory process that should be followed, and ● navigate applicants through the process step-by-step. Also included are links to relevant guidance and forms. Successful completion of the process gets the product listed in the Australian Register of Therapeutic Goods (ARTG). The process was originally published in November, then updated in December to include instructions regarding payment of registration fees that go into effect on January 1, 2016. TGA also published instructions on how to change a listing for a product that is already in the ARTG.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
