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Duplicate Marketing Authorisations in the EU: Evolution of the Regulatory Framework and Practical Implications

Ian Dodds-Smith, Alexander Roussanov


This article gives an overview on the evolution of the legal framework and of regulatory guidance developed by the European Commission relating to the grant, under the EU centralised system for authorisation of medicinal products, to the same company of more than one marketing authorisation for the same product. . Such so-called ‘duplicate’ authorisations are allowed in the circumstances described in Article 82.1 of Regulation (EC) 726/2004 (‘EMA Regulation’). The review below addresses the current restrictions in the legislation and the authors also comment upon the ongoing discussion concerning a revision of the guidance issued. While, to the best of the authors knowledge, the European Medicines Agency (‘EMA’) does not provide statistics on the number of duplicate marketing authorisations granted, a cursory search on the EMA website suggests that a significant number of such marketing authorisations have been granted by the European Commission and over 20 are still valid. The European Commission’s note on handling of duplicate marketing authorisation applications (‘the 2011 Guidance’) states that requests are steadily increasing.

Ian Dodds-Smith, Partner, Co-head of the Arnold & Porter's Food, Drug and Medical Device practice; Alexander Roussanov, Partner, Arnold & Porter. For correspondence: <>


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