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. 8. O. btaining a marketing authorisation within the European Union .. 8. European Union marketing authorisation the centralised 9. National marketing authorisations national, mutual recognition & decentralised 9.
The guide focuses primarily on the requirements for authorising medicinal products for human or veterinary use. The guide is not intended to be an exhaustive document but rather to raise SMEs’ awareness of the various more detailed sources of information available. In December 2005, Commission Regulation (EC) No
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