EMA: Regulatory and procedural guideline: User guide for micro, small and medium-sized enterprises (SMEs) on the administrative and procedural aspects of the provisions, laid down in Regulation (EC) No 726/2004, that are of particular relevance to SMEs
This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stages of developing a medicinal product. An overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (EU) is provided. The regulatory procedures in place to optimise development and obtain an EU marketing authorisation are also summarised.