Module 12 2019

Current status of ongoing programmes: Gateway and CESP EMA HMA

EMA Gateway: Submission to EMA

CESP: Submission to EU NCAs

CP: initial, variations, renewal, referral, PIP, SA

MRP/DCP/NP: all kind of activities

SINGLE SUBMISSION PORTAL Does it still makes sense to submit and review electronic documents, instead of receiving, assessing and approving electronic data?

The Organisation for Professionals in Regulatory Affairs