Module 12 2019

CESSP

CESSP is a programme contained in the eSubmission programme which will eventually result in the implementation of the Common European Single Submission Portal.

Dossier

CESP

CESP

EMA/ NCA

EMA Gateway

Draft Cover Letter,

Import file for IT systems

SPOR

Draft a business and technical scenario how PMS could consume and utilise application data

Start and Finalise Application Dataset

Finalise dossier submission

Process submission

Submit

The Organisation for Professionals in Regulatory Affairs