The implications of Brexit are still being felt. Politically, the decision has triggered a chain of events that none of us could have ever foreseen. Now, with a new Prime Minister in Downing Street and three leading ‘Brexiteers’ appointed to offices of state that are critical to the delivery of the wishes of the majority of voters, we are certain that “Brexit Means Brexit”.
There is now great uncertainty for the industry sectors that we cover. Questions about appropriate regulatory strategies, potential differences in regulatory frameworks, the re-location of the European Medicines Agency, loss of a powerful national competent authority all hang in doubt. This briefing document aims to throw light on what Acorn Regulatory sectoral experts know now and what they believe will happen.
We have become the ‘go-to’ people for companies seeking regulatory advice regarding ‘Brexit’. Since late last year, we have fielded countless queries from long-standing and prospective clients as to how their companies and their products might be impacted by a British decision to leave the European Union. We are happy to answer queries from any company on the regulatory issues relating to the vote. Please feel free to contact our team on 00353 52 61 76706 at any time about the issue.
Acorn Regulatory has a large team of experts based at our headquarters in Ireland and working with our clients on sites in Ireland, the UK and mainland Europe. We have a truly global client list supplemented by access to a wide network of specialists in local markets.
We will produce further ‘Brexit’ briefings as more information becomes available to us. We would recommend visiting the Brexit section on our website regularly to keep abreast of industry relevant updates on this issue and others.
The Implications on Existing Marketing Authorisations
London, as host city to the European Medicines Agency (EMA), with a full-time staff of more than 800, is the largest EU body in Britain and has overseen pan-European drug approvals since 1995 from its headquarters tucked away among global banks in London’s Canary Wharf. The centralised procedure is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance, which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes.