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Entering the EU Market of generics: products’ registration, do’s and don’ts

Written by Paola Cinquanta | Apr 26, 2023 10:25:41 AM

The European Market is the second-largest market in the world for pharmaceuticals; indeed, out of the estimated € 1,062,707 million of the world’s pharmaceutical (prescription) market, the European market contributes 23.4%, confirming it is the second-largest market (source: IQVIA (MIDAS) Q4 2021 MAT, May 2022; data relate to 2021). The European pharmaceutical sector provides a €109.4 billion trade surplus (data source: Eurostat) thanks to a strong and competitive market. 

The generics market covers more than 50% of the global pharmaceutical market. Generics are essential to ensuring widely available treatment options that are accessible to all patients. Governments and Public Payers rely on generics to contain the pharma expenditure, and the growing rate of chronic diseases is expected to further boost the generic drug market worldwide.