The European Union’s current regulations for the licensing of generic and hybrid medications

Abstract

In the European Union, the applicant must specify the legal justification for the application in any Marketing Authorization Application (MAA) for a pharmaceutical product. The dossier's content and the market exclusivity are significantly influenced by this legal foundation, which is outlined in Directive 2001/83/EC as modified. The right legal foundation must be chosen carefully for new development projects involving active chemicals that are already known, including novel strengths, dosage forms, administration methods, and indications. In accordance with Article 10 and the so-called "hybrid" and "generic" applications, this article describes the registration criteria and the procedure for obtaining a marketing authorization for applicants utilizing the Article 8(3) legal foundation.