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MedicineHumanAuthorised
MedicineHumanAuthorised
MedicineHumanAuthorised
The main objective of the small and medium-sized enterprises (SME) Regulation (Commission Regulation (EC) No 2049/2005) is to provide financial and administrative assistance to these enterprises through the SME office of the European Medicines Agency (EMA). It also aims to address the needs of smaller companies in the pharmaceutical sector.
HumanRegulatory and procedural guidanceSME
MedicineHumanAuthorised
HumanScientific guidelines
MedicineVeterinaryAuthorised
MedicineVeterinaryAuthorised
MedicineVeterinaryAuthorised
MedicineVeterinaryAuthorised