Transcription of User guide for micro, small and medium-sized enterprises
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User guide for micro, small and medium-sized enterprises
User guide for micro , small and medium-sized enterprises on the administrative and procedural aspects of the provisions laid down in regulation (EC) No 726/2004, that are of particular relevance to SMEs An agency of the European Union User guide for micro , small and medium-sized enterprises on the administrative and procedural aspects of the provisions laid down in Regulation (EC). No 726/2004, that are of particular relevance to SMEs SME Office Addressing the needs of small and medium-sized enterprises Latest revised version July 2016. EMA SME USER guide . Table of contents 1.
This guide has been prepared for micro, small and me - dium-sized enterprises (‘SMEs’) operating in the phar-maceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stag-es of developing a medicinal product. An overview of
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