Established in 2002
With the festive season upon us and 2019 on the horizon, Ivowen Ltd are setting our sights on the year ahead. So what’s going on in 2019 and beyond, including and excluding Brexit… What’s happening in early 2019? We will be attending the Medicines for Europe Regulatory and Scientific Affairs and Pharmacovigilance conferences in January […]
As the date for the withdrawal of the UK (also known as Brexit) from the EU approached closer, it pays to hope for the best and prepare for the worst. With this in mind, the EMA have issued a guidance document on “Practical guidance for procedures related to Brexit for medicinal products for human and […]
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 […]
I am delighted to announce the promotion of Alice D’Alton to the role of Regulatory Affairs and Business Manager. Alice has been an integral part of the team here in Ivowen for over three years and has more than 10 years experience working in the pharmaceutical industry. This new role within Ivowen will facilitate the […]
In my circle of friends I feel like I am the “Chandler Bing” and it’s not because I am the funny one; no, it’s because no one knows or understands what I do for a living. My mother still believes I work in a laboratory and have a working knowledge of all medicines and once […]
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 […]
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 […]
Ivowen Limited will be attending the upcoming 9th EGA Pharmacovigliance, and the 15th EGA Regulatory and Scientific Affairs Conference in London from from 27th-29th January. Please contact us if you would like to arrange a meeting.
Alice D’Alton from Ivowen Limited was delighted to be asked to provide a summary of Session 4 at the recent TOPRA Annual Human Medicines Symposium 2015. The full summary is provided in the following link: SESSION 4: Globalisation of pharmaceutical regulation – What do agencies discuss behind closed doors? For further information or if you […]
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, […]