Acorn Regulatory’s Essential Guide to Brexit
The ‘Essential Guide’ looks at Brexit from the pharmaceutical, medical device, clinical and pharmacovigilance perspective.
We hope that you find this essential guide to be useful.
CMC & Pharmaceutical
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 your business. Read more here.
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.
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 a 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.
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 for the pharmaceutical industry. Clinical trial sponsors and associated partners should be prepared for a variety of scenarios arising from Brexit which could impact the manufacturing, licensing and distribution of health products between Ireland and the UK.
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.
Pharmacovigilance & Clinical
Brexit will impact on many aspects of the life sciences sector. One of the areas that will be most impacted will be the role of the Qualified Person for Pharmacovigilance (the QPPV). In this article, we consider the impact that the UK’s exit from the EU will have on the role and the measures that companies will need to take once Brexit happens. Read More Here.
How will the Pharmacovigilance System Master File (PSMF) be impacted by the UK’s departure from the EU? What actions will companies with a UK Marketing Authorisation Holder (MAH) need to take in the event of a no-deal Brexit? In this short article, we consider the questions and give advice on what you need to consider and what you need to do if you are impacted. Read More Here.
How will clinical trials be impacted by the UK’s decision to leave the European Union?
The United Kingdom’s decision to leave the European Union (EU) will present significant implications for the pharmaceutical industry. Clinical trial sponsors and associated partners should be prepared for a variety of scenarios arising from Brexit which could impact the manufacturing, licensing and distribution of health products between Ireland and the UK. Read More Here.
Does your company currently have an EU Authorised Representative that is based in the United Kingdom? If so, your company will have to consider moving EU Authorised Representative very soon to ensure that you have representation with the European Union once the UK leaves the European Union. Acorn Regulatory can assist you in moving your EU Authorised Representative from the UK to Ireland. The result of the December 12th, 2019 election saw the Conservative Party win an overwhelming majority, having campaigned on the slogan ‘Get Brexit Done‘. Read More Here.
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022. Read More Here.
You can read our full collection of Brexit articles and whitepapers by clicking here.
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