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SME Status

EU INCENTIVES

In order to promote innovation in smaller companies, the European Medicines Association (EMA) supports Micro, Small and Medium-sized enterprises (SMEs) through incentives to help them overcome the main financial and administrative hurdles.

To benefit from the initiative, SME status must be assigned by EMA before a regulatory submission. Therefore, it is recommended to consider registration as an SME early during development.

NON-EU COMPANIES

Non-EEA companies can register as SMEs and indirectly benefit from the SME incentives through RPN.