User guide for micro, small and medium-sized enterprises (SMEs) on the procedural and administrative aspects of the provisions, laid down in Regulation (EC) No 726/2004, that are of particular relevance to SMEs

The aim of this guide is to facilitate understanding of the main aspects of medicinal product legislation. It focuses primarily on the requirements for authorising innovative medicinal products for human or veterinary use. It is not intended to be an exhaustive document but rather to raise SMEs awareness of the various detailed sources of information which are available.