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Quality Indicators That Affect Pricing

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Generic Medicines: Definition, Contents, and Development Timeline (questions-answers-generic-medicines_et.pdf)

66 KBEuropean Medicines AgencyEN 3 pages
A generic medicine is an identical copy of an existing authorized medication, with the same active substance, dose, and treatment purpose, but potentially different branding and packaging. It requires approval to demonstrate bioequivalence to the reference medicine.
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generic medicine medicines definition contents development timeline identical existing authorized medication active substance treatment purpose branding packaging requires approval demonstrate bioequivalence reference

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