Europe – User guide for micro, small and medium-sized enterprises

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.

The guide focuses primarily on the requirements for authorising medicinal products for human or veterinary use. It also includes a section on activities related to medical devices. The guide is not intended to be an exhaustive document but rather to raise SMEs’ awareness of the various sources of information available, with links throughout the text to additional information…