Excipient guideline update

The updated Annex to “Excipients in the labelling and package leaflet of medicinal products for human use” guideline was published on the 09/10/2017. This updated Annex in all EU languages can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001646.jsp In addition, Notice to Applicants Volume 2C has been updated in March 2018 to reflect this updated annex. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c/guidelines_excipients_march2018_en.pdf What […]

eCTD is coming…

All good (and bad) things, must come to an end.  The NeeS (Non-eCTD electronic submissions) submission format, will no longer be accepted for any Marketing Authorisation applications (MAAs) or submissions in MRP or DCP from 1st January 2018. Centralised Procedure (CP) submissions have been mandatory in eCTD since 2010.  All new MAAs submitted using either […]

Christmas closing times 2017

The office will be closed from Friday 22nd December 2017 to Monday 1st January 2018 inclusive for the Christmas holidays.  We wish all our friends, families, colleagues and clients a joyful festive season.  Thank you for all your custom in 2017 and we look forward to bigger and better in 2018!  

Launch of the new EudraVigilance System – National arrangements for Ireland and what this means for you

With the launch of the improved EudraVigilance (EV) System, and the move to the simplified reporting of adverse reaction reports (ADRs) on 22nd November 2017, Marketing Authorisation Holders and EV users in Ireland must familiarise themselves with the HPRA’s national arrangements that will be in place during the changeover period. As of 4th November the […]

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 […]

Ivowen Limited shortlisted for Healthcare and Life Sciences Award 2017

Award nomination We are delighted to announce our shortlisting for the CorporateLiveWire Healthcare and Life Sciences Award 2017. Each year nominations are accepted for both companies and individuals. The voting process is open for 12 months and all nominees will be given the opportunity to share additional information about their business and recent achievements. The […]

Ivowen Limited hosts 2017 conference

Dublin, the venue It was our pleasure to host the EuDRAcon conference for 2017 in Ireland on 1st and 2nd of June.  We welcomed representatives from 21 Member States, including our new member from Cyprus, Nicolas Constantinou from Niconex Medical.  EuDRAcon currently has participating members in 25 of the current 31 EEA member states, plus […]

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 […]