Brexit Pharma Info: Updated for 2019

The election of Boris Johnson as the new Prime Minister of the United Kingdom has put the issue of Brexit firmly back on the political agenda, after a number of months of relative inactivity.  His stated willingness to pursue a no-deal Brexit if a deal cannot be reached by October 31st 2019 has alarmed many people in industry.  Here, we have compiled a number of articles from our extensive Brexit library that might assist you in any efforts that you or your company are undertaking to prepare for Brexit, in whatever form it takes.

Brexit Pharma Info for the Pharma Sector

1)How Brexit Will Impact UK Marketing Authorisation Holders

The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s decision to leave the European Union.  Aside from the considerable upheaval brought about by the need to relocate to Amsterdam, the issues brought about by Brexit have been manifold.   In this article we look at  one of the main questions highlighted by the EMA relating to UK Marketing Authorisation Holders and provide additional resources to assist you in better understanding how Brexit might impact on your business. Read more here.

2)Brexit: Implications on Existing Marketing Authorisations

In the media flurry around the idea of a no-deal Brexit, much has been made about the availability of medicines.  Brexit will have an impact on existing Marketing Authorisations.  This article, originally written in July 2017, looked at the implications for MAH’s.  Now, in 2019, many of the issues raised in the article have still not been properly clarified for MAH’s. Read more here.

3)How Will The UK Life Sciences Sector Address Post Brexit Skills Shortages

When this article was originally written in late 2016, it was widely expected that Brexit would have happened by mid 2019 and that the issue of skills shortages would have been addressed.  Now, at the time of writing in 2019 neither has yet been dealt with.  The UK pharmaceutical sector employs in excess of seventy thousand people. The structure of a Brexit will have significant impact on them and the industry that they work in. For now, there is a firm belief that the UK will make a full exit from the single market and, with that, there will be restrictions on those seeking to move to the UK. How will the UK handle post Brexit skills shortages? Read more here.

4)Brexit Clinical Trials Sector Implications

This article, written by our Clinical & Medical Manager  Dr. Danica Cvetkovic looks at what we know now, in 2019, about the impact of Brexit on Clinical Trials. The United Kingdom’s decision to leave the European Union (EU) will present significant implications to the pharmaceutical industry. Clinical trial sponsors and associated partners should be prepared for a variety of scenarios arising from Brexit which could impact on the manufacturing, licensing and distribution of health products between Ireland and the UK.

Read More Here.

5)Brexit: The Implications on Existing Marketing Authorisations

In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations. London, as host city to the European Medicines Agency (EMA), with a full-time staff of more than 600, 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. Read More Here.

About the Author:

Brian Cleary
Chief Marketing Officer
Brian is Chief Marketing Officer at Acorn Regulatory. He works with our growing team to highlight some of the most important issues in regulatory affairs and pharmacovigilance. Brian also manages HR and recruitment issues for the company. You can read other articles by Brian by clicking the link below.
Other Articles by Brian Cleary

Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD

Dr. Danica Cvetkovic
Dr. Cvetkovic heads up our Clinical & Medical team at Acorn Regulatory. She has significant experience in the clinical and medical sector. Prior to joining our company she headed the medical department of a major pharmaceutical company in her native Serbia. You can read more articles by Dr. Cvetkovic by clicking the link below.
Other articles by Dr. Danica Cvetkovic