EMA eSubmission Gateway – tips & tricks

Current State of Play As many of you know, the EMA eSubmission Gateway/Web Client has been mandatory for all submissions for human medicinal products made through the Centralised Procedure since March 2014 and for veterinary products since January 2017.  In addition, all PSUSA/PBRER submissions are also made through this EMA eSubmission Gateway, and have been […]

CESP expands in Poland and Greece

Latest news from Poland and Greece for CESP From 3rd April 2017 it will be possible to submit the following procedures via Common European Submission Portal (CESP) to Poland: Initial Marketing Authorisation Applications (MAAs) Variations Renewals The submissions may concern national and European procedures (MRP, DCP) both for human and veterinary medicinal products.   Also […]

Ivowen attends EudraVigilance Training Course on Reporting of ICSRs/SUSARs in the EEA – Suspected Adverse Reactions to Medicines

What is EudraVigilance? EudraVigilance (http://eudravigilance.ema.europa.eu) is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA) and supports the safe and effective use of medicines (Figure 1 – EudraVigilance System Components).  Adverse reactions (ADRs) can be reported during the development […]

PSUR repository updated

On the 26th of January 2015, the EMA introduced the pilot phase on the use of the XML delivery file for submissions of PSURs via the eSubmission Gateway/Web Client. This introduction, 1) Simplified package file names for PSURs and 2) Introduced the requirement of an XML delivery file. The XML delivery file is created in […]

EMA introduces changes to the QRD templates

The EMA has introduced changes to the QRD templates of the product information that accompany all medicines authorised for use in the EU including package leaflet (PL) and the summary of product characteristics (SmPC). Full details are available here: Summary of Main Changes: The changes to Quality Review of Documents (QRD)  templates are detailed in […]