2019 – What a year

Ivowen Limited attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November. We all saw Brexit come and go, Twice !! We wait to see what lies in store for the […]

Ivowen attended TOPRA Symposium 2019

This year’s TOPRA Annual Symposium was held in Dublin in October. The Annual Symposium is an essential meeting for regulatory professionals to gain both an understanding of current and evolving regulatory requirements, as well as insights into future plans for regulations in the Human medicines, Veterinary medicines and Medical Device sectors. Three members of our […]

Brexit – extension, extension, extension

Brexit extension date is now 31 October 2019, but there’s not time to be complacent. Are you planning to submit a Marketing Authorisation Application (MAA) for a Non-Prescription Medicine? If you are preparing an MAA for a Non-Prescription Medicine for a Decentralised (DCP) or Mutual Recognition Procedure (MRP) you will need to prepare a ‘Justification […]

Brexit – because it affects you too…

The European Union is arguably the world’s most powerful bloc and very soon it’s about to lose the United Kingdom, one of its biggest members. How and when the UK leaves the EU will have further implications that ripple around the globe. So if you’ve heard about Brexit but haven’t been keeping up with every […]

Brexit… it’s getting closer…

Ivowen Limited have provided some practical guidance and documents below, which may help you prepare for Brexit for products authorised by the DCP and MRP procedures. Take our Brexit quiz to see if you are ready. Do you still need to change your MAH(s) in any of the EU Member States because of Brexit? If […]

To 2019 and beyond (Brexit)…

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 […]

HPRA’s support as you prepare for Brexit……

Brexit in: The Health Products Regulatory Authority (HPRA) of Ireland is geared up and ready to support MA holders as they prepare for Brexit.   What happens if UK leaves the EU with no deal? The implications of Brexit with regard to the UK’s role in the licensing of medicines will be determined by the […]

Are you Brexit ready?

Brexit in: Test your knowledge, take our Brexit quiz here  What do you want to do next?  Do you want to continue to market your product in the EU only, or are you interested in both the EU and UK markets?  Read on to find out what you need to do for both scenarios. If […]

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 […]

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 […]