The European Commission’s formal call last week on Italy to comply with European Union rules on the marketing authorization of generic medicines was welcomed by the European Generic medicines Association (EGA) together with the Italian association for generic medicines (ASSOGENERICI).
The European Commission infringement procedure started last year, following the EGA and ASSOGENERICI’s official complaint to the European Commission against the delays in granting market authorization of generic medicines caused by incorrect linkage to intellectual property rights.
“Patent linkage” abuse of regulatory system
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