Abstract
For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis for the application. This legal basis, laid down in Directive 2001/83/EC as amended, determines the dossier content, the market exclusivity, and the pediatric requirements in a significant way. For new development projects for established active substances, including new strengths, dosage forms, routes of administration, and new indications, the correct choice of legal basis is critical. This article presents the dossier requirements, data protection, and market exclusivity as well as pediatric obligations for mixed MAAs using the Article 8(3) legal basis and so-called “hybrid” applications according to Article 10(3). These legal bases in the European Union are contrasted with applications according to section 505(b)(2) in the United States. A number of case studies are presented to illustrate which factors can determine the legal basis of an MAA.
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