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National Awareness Campaign Newsletter No 2. September 2007 The Australian Medical Association (AMA) supports the NPS Generic medicines are an equal choice campaign and encourages doctors to discuss
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Generic medicines are identical or bioequivalent to brand-name medicines in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
Manufacturers and distributors of generic medicines are required to file for approval from regulatory authorities.
To fill out a generic medicines application, manufacturers need to provide documentation demonstrating the bioequivalence, safety, and efficacy of the generic product compared to the brand-name product.
The purpose of generic medicines is to provide more affordable treatment options to consumers by creating competition in the pharmaceutical market.
Information such as active ingredients, dosage form, strength, labeling, and packaging must be reported on generic medicines applications.
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