EU regulatory frameworks and pharmaceutical law

摘要

Tnis article describes the legal and administrative frameworks and procedures for the regulation, grant of marketing authorization and subsequent safety vigilance activities required to comply with European law within member states of the European community. In particular we consider the components of the submission dossier for authorization, the methodologies used to evaluate the appropriate risk: benefit of new medicinal products and the different procedures used in submission to ensure harmonization of product authorizations and details throughout the EU.