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Market Exclusivity

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The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be placed on the market.

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Good PharmacoVigilance Practices (GVP) for the European Union

A set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based…

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Device User Facility

A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as…

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