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Minor variations to registered prescription medicines: Biological medicines
All prescription medicines available for general marketing in Australia are registered in the Australian Register of Therapeutic Goods (ARTG). Section 2.5 of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) sets out the kinds of applications that can be made to enter medicines into the ARTG. Different processes, forms, timeframes and fees apply, depending on the type of application and category.
This document provides guidance for making minor variations to existing ARTG entries.
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