Where will we be in 2016?

We are already in Quarter 2 of 2016 and as it comes to the end of April we thought it necessary to update current and potential clients as to where we will be and where you can meet us in 2016. As a company providing expert advice and support to our clients we at Ivowen […]

Falsified Medical Directive (FMD) and updated QRD template released February 2016

Falsified medicines are fake medicines that are designed to mimic real medicines. Due to the increase of falsified medicines on the market the EU has a strong legal framework for licensing, manufacturing and distribution of medicines. In July 2011 DIRECTIVE 2011/62/EU (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF ) came into force; this directive aims to prevent falsified medicines entering the […]

Points to note on the eAF

General The eAF is mandatory for all procedures from 01/01/2016 (CP, MR, DC, National in eCTD/NeeS/Paper). However, Presubmission Meeting Requests, Article 61(3) & MAT forms remain the outside scope and can be submitted as paper or PDFs. Please contact us if you require any assistance with any of the forms or any advice on any […]

CESP delivery system updated

The latest CESP system, version 2.0, was officially launched on October 1st 2015 (https://cespportal.hma.eu). Ivowen Limited has been using this facility regularly and can help to guide you through any aspects that you may be struggling with. There are a few new features which sets it apart from the old version: The delivery file creation, […]

Regulatory Science Ireland (RSI) Seminar

Regulatory Science Ireland (RSI) Seminar, Cork, 8th September 2015 Ivowen Limited recently attended the Regulatory Science Ireland (RSI) Seminar hosted by Dr. Kevin O’Donnell (HPRA) and Professor Caitriona O’Driscoll (School of Pharmacy, UCC), which was followed by a round table interactive Q&A session. RSI is a new organisation that carries out research and education in […]

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 […]