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Glossary

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.

Other glossary definitions

E

Environmental Risk Assessment (ERA)

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential…

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G

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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