Abstract
Small and medium-sized enterprises (SMEs) are at the core of the European Commission competitiveness policy. With the entering into force of the latest revision of the European pharmaceutical legislation, new regulatory provisions have been laid down to help these small but dynamic players when dealing with the so-called centralised marketing authorisation procedure and the European Medicines Agency (EMEA). The new incentives address both financial and administrative aspects, such as fee reductions and deferrals for a number of EMEA services, handling of translations, and the establishment of a dedicated SME Office within the Agency. In this paper we explore the newly established regulation and the various provisions to analyse its implications for SMEs in general and generic manufacturers in particular. We also review the underlying assumptions, especially the Community SME definition, and discuss the policy objectives that led to the establishment of this new piece of legislation.
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