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. Overview of (data) requirements for obtaining marketing authorisation in the EU legislative framework for 10.
The centralised procedure is mandatory for certain types of medicinal products and optional for others. Medicinal products (both for human and veterinary use) developed by means of one of specified biotechnological processes7, veterinary medicinal products intended primarily for use as performance enhancers, advanced therapy medicinal
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