Below you'll find the highlights that we have selected for you regarding regulatory, pharmacovigilance and quality related matters in the Life Sciences industry in a chronological
Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of medicinal products for human and veterinary use no longer apply to the United Kingdom. This has, in particular, the following consequences in the different areas of EU law on medicinal products:
The European Medicines Agency (EMA) is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.
More clarified information on the positioning of the MHRA in its current environment and future Brexit changes to ensure continuity.
According to the HPRA, there are many areas to consider regarding Brexit - but these also all subject to change depending on the Brexit government discussions. This is explained clearly is this guidance for areas like
The Management Board of the European Medicines Agency (EMA) heard from Executive Director Guido Rasi and Deputy Executive Director Noël Wathion how the Agency is preparing for relocation to Amsterdam in the Netherlands, and operationally for the United Kingdom’s (UK) withdrawal from the European Union (EU). This is the first meeting of the Board since the General Affairs Council (Art.50) of 20 November and the decision of the EU 27 Member States to relocate the Agency to Amsterdam. EMA now has just over 15 months to prepare for the move and take up its new seat in Amsterdam by 30 March 2019 at the latest.
EMA and the Dutch authorities are currently working on a Memorandum of Understanding (MoU). The Board was also informed that EMA’s Brexit preparedness business continuity plan will enter Phase 2 in January 2018.
This Q&A document explains from the manufacturing, release and distribution perspective and recommends that Life Sciences companies should be pro-active to ensure compliance and efficiency during Brexit.
On 2 May 2017, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) published a Notice to marketing
The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing
Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.
The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.
The Dutch Health Authority has promoted its offer to attract the EMA in a nice looking website.
A slide deck with the insightful results of a survey performed by the European Association of Pharmaceutical Industries and Associations surrounding the impact that Brexixt will have on the Life Sciences Sector.