Firstly, in this very unusual time for us all I want to let you know that our dedicated team are all healthy, safe and working from home, business as usual, to ensure that we continue to provide you with the high quality and efficient service you have come to expect from Ivowen. Have you ever […]
Covid-19 – Ivowen contingency In light of recent developments concerning the Coronavirus (COVID-19), Ivowen has put in place contingency measures to safeguard the health and well-being of our staff and to maintain business continuity. Ivowen will monitor and adhere to Irish Government advice on delaying the spread of the virus, including but not limited to: […]
As an MAH, do any of your authorised human medicinal products contain chemically synthesised active substances? If so, read the following to identify what your responsibilities are with regard to reporting results of risk analysis to the appropriate Competent Authorities by 26 March 2020 deadline. On 20th December 2019, the EMA published a Q & […]
Like me, you probably get survey requests into your Inbox every day. Like me, you probably ignore most of them. Don’t ignore this one! The European Commission is doing a survey on national regulatory fees for human medicines and it is available to everyone here. Have your say, and encourage the EC and NCAs to […]
The United Kingdom has formally left the EU as of 31 January 2020 and has become what is referred to as a third country. On 1 February 2020 a transition period started which is due to end on 31 December 2020. During the transition period, EU pharmaceutical law will continue to be applicable to the UK, meaning that […]
Ivowen 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 next […]
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 […]
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 […]
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 […]
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 […]
Teams and team building is an important part of any workplace. We recently had a rare opportunity to have all our staff members on site at the Ivowen base in Clonmel and this was the perfect opportunity to hold a team building session. It was a fun afternoon’s activity where everyone had the opportunity to […]
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 […]
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