Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Pro
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Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs
Drug Information Journal 46(4) 479-484 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512443748 http://dij.sagepub.com
Andreas M. Vogel, PhD1
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. Keywords marketing authorization application, hybrid, 505(b)(2), data protection, development plan
Introduction Problem Statement: When and Why Is the Choice of the Legal Basis an Issue? Available Legal Bases According to Directive 2001/83/EC For any medicinal product Marketing Authorization Application (MAA) in the European Union (EU), the applicant needs to define upon which legal basis the application is made. The available legal bases are defined in the European Directive 2001/83/EC,1 which provides the harmonized basis for the pharmaceutical legislation across the EU member states (Table 1). The required elements of a full application are defined in Article 8(3). In addition, Annex I, Part II.7 of the same Directive specifies that ‘‘a combination of reports of limited non-clinical and/or clinical studies carried out by the applicant and of bibliographical references’’ may be used to supply these required elements; such applications are called ‘‘mixed MAA.’’1 All other legal bases represent specific types of derogations to the dossier requirements laid down in Article 8(3) (see also Table 1):
Article 10(1) and 10(2) for bioequivalent generics
Article 10(3), known as ‘‘hybrid’’ application, for applications of generics for which bioequivalence cannot be shown or which differ from the originator product (reference medicinal product [RefMP] in EU terms) in therapeutic indication, strength, pharmaceutical form, or route of administration Article 10a for bibliographical (so-called well-established use) applications Article 10b for fixed combinations Article 10c informed consent (ie, duplicate) application dossiers Hybrid applications are of particular interest for the pur
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