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EMA - User guide for micro, small and medium-sized enterprises

Year: 2025

Type: other

Abstract: The guide helps companies navigate the regulatory requirements and incentives available throughout a medicine's product lifecycle. It provides an overview of procedures to support research and development activities, and improves understanding of what is needed to obtain a marketing authorisation in the European Union (EU) / European Economic Area (EEA). The updates concerns the Upcoming legislative changes, the incentives offered by EMA to SMEs, the PRIority MEdicines (PRIME) scheme for hum...

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/13xy6

Author: Vroby

Language: English

Topic: Pharmaceutical Economics and Policy

Subfield: Economics and Econometrics

Field: Economics, Econometrics and Finance

Domain: Social Sciences

Open Access status: green

OpenAlex ID: W6899117580

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