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!
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 […]
What is a Referral all about? A Referral to the EMA and CHMP is a procedure used to resolve issues such as concerns over the safety or the benefit-risk balance of a medicine or a class of medicines. The matter is ‘referred’ to the European Medicines Agency, so that its expert committees can make a […]
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 […]
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 […]
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 […]
When the Clinical Trial Regulation (No. 536/2014) comes into effect in 2018, there will be a major change on how clinical trial applications are submitted and how clinical trials are conducted in the EU. The goal of the new Regulation is to create an environment that is favourable to conducting clinical trials in the EU, […]
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 […]
Elemental impurities guideline What is it… The ICH has introduced this new guideline to control the elemental impurities that may be present in drug products. It replaces EMEA guidance on Specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000). This guideline applies to new drug products (with a new drug substance) and to […]
The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted classification system for medicines. This system is maintained by the World Health Organisation (WHO). The WHO assigns ATC codes to all drug substances based on their therapeutic indication. The assigned ATC code must be present in your product information. What does this mean for you? […]
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 […]
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 […]
Dungarvan Enterprise Centre,
Old Friary Building,
Lower Main Street, Dungarvan,
Co. Waterford, X35 FX45,
Ireland.