Company Announcement – Majella Ryan FTOPRA

Ivowen Limited are pleased to announce that Fellowship of The Organisation for Professionals in Regulatory Affairs (FTOPRA) has been conferred on Majella Ryan.  According to TOPRA: “The award of a Fellowship is intended to recognise a contribution in which the individual has used his/her professional knowledge and experience to influence, guide or develop the profession in […]

Preparing for Brexit

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 […]

HPRA now part of the EU-US Mutual Recognition Agreement (MRA)

As of 1st June 2018, Ireland became one of the recognised member states in the Mutual Recognition Agreement (MRA) between the EU and the US FDA. What is the MRA? The Mutual Recognition Agreement (MRA) is an agreement between countries concerning the conformity assessment of regulated products.  From the pharmaceutical point of view, this means […]

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 2014.  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 […]