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 […]

Are you interested in online training??

In an ever changing and at times a fast paced environment the world of pharmaceuticals demands cohesion and understanding across the board, to allow growth and success in any business either directly or indirectly involved with it. With regulations and guidelines becoming more stringent and extensive along with constant revisions and updates of the same […]

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 […]

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 […]