AN INTROSPECTIVE ACCESS IN ASSORTMENT OF DRUG DOSSIER AS PER EU GUIDELINES.

J. Balasubramanian*, K.S. Lakshmi, E. Pavithra and Sruthi Krishnan

ABSTRACT

The retrospective approach of the compilation of dossiers for applications of European marketing authorizations is applicable for the centralized procedure and national procedures, including mutual recognition and decentralized procedures. The European Union contains scientific committee, members, European Union member states. The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU). The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorization applications for human medicines. Guidelines reflect a harmonized approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

Keywords: .