eSubmission Roadmap updated

The European Union updated its eSubmission Roadmap in June 2019 to reflect changes in timelines. What is it? The eSubmission roadmap is a high level, strategic plan for business and technology changes within the EU.  Its function is to align the plans and implementation timelines of target groups and stakeholders, including the EMA, National Competent […]

News from the HPRA

The HPRA are always striving to improve their processes and ways of working.  The following updates in the Human Medicines Department should help us all in our dealings with each other. New electronic workflow system The human medicines department within the HPRA have transitioned to using a new (internal) electronic workflow system. Due to this […]

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 […]

Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….

An Environmental risk assessment (ERA) of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified. The EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders […]

HPRA update on Batch-specific requests for safety features

The recent medicinal products newsletter (issue 61) published by the HPRA includes an article about batch-specific requests (BSRs) and safety features.  This is an update on the Falsified Medicines Directive safety features information. The Commission Delegated Regulation (EU) 2016/161 with detailed rules for the safety features appearing on the packaging of medicinal products for human […]

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 […]