PharmaLex | Brexit and the Pharma Industry - January 2018 Updates

As we near the end of January 2018, the date of 30th March 2019 is looming ever closer to end the UK’s EU membership and the application of all EU legislation in the UK will end with it. Two recent updates have been issued by the EMA in relation to Brexit and the position of UK pharmaceutical companies. EMA Survey Launch The agency issued news on 23-Jan-2018 that it is launching a survey to all pharmaceutical companies in the UK to gain information on their Brexit readiness plans. The aim is to gather information from companies on their Brexit preparedness plans and to identify any particular concerns with regard to medicines supply that may impact public or animal health. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/01/news_detail_002890.jsp&mid=WC0b01ac058004d5c1. The survey is intended for MAHs of centrally authorised medicines that are located in the UK, or who have an important part of their operations located in the UK (eg. who have quality control, batch release, and /or import manufacturing sites or a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) in the UK.) The aim of the survey is

to identify companies that may need concerted action to address medicine supply concerns due to Brexit
to plan resources in the areas where these submissions will be processed.
to serve as a stimulus to those companies who have not yet taken any action to start planning for any regulatory steps required for their centrally authorised products to remain on the EU market post Brexit.

The deadline for completion of the survey is 9 February 2018 and a high-level summary will be published on the EMA website. On a similar note, EFPIA published survey results on Brexit in November and our industry news reported on this previously (on the following link): https://mcgeepharma.com/eur/efpia-publishes-survey-results-on-brexit-amid-calls-for-maximum-regulatory-alignment/ Key findings from the EFPIA survey included the below

Over 2,600 final products have some stage of manufacture within in the UK
45 million patient packs are supplied from the UK to other EU-27/EEA countries each month
Over 37 million patient packs are supplied from the EU-27/EEA to the UK each month
Over 12,000 centrally authorised Marketing Authorisations (MAs) for medicines will require a separate MA in the UK in order for the medicine to be prescribed to patients.
Approximately 17% of centralised MAs are held in the UK.
There are over 1500 clinical trials on-going with UK as sponsor and over half of these trials are predicted to be continuing at the time when the UK is due to withdraw from the EU, in March 2019.

Updated EMA Guidance for UK Withdrawal from EU The agency and the European Commission published updated guidance to answer questions about Brexit. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf On Dec. 1, 2017, the European Medicines Agency (EMA) and the European Commission published updated guidance for pharmaceutical companies regarding the United Kingdom’s withdrawal from the European Union. This version is an update of the initial questions-and-answers document that was published at the end of May 2017. Updates are marked ‘NEW’ and there are eight new questions and answers added to include additional information on how the UK’s withdrawal from the EU will affect marketing applications and authorisations for different types of medicinal products, for example, generic, hybrid and biosimilar medicines. Detail is included on batch release sites located in the UK, which must be located in the EU; the effect on herbal medicinal products; bioequivalence studies and applications for orphan drug designation. The guidance also discusses the local representatives in the UK mentioned in product information, global marketing, and the sunset clause. With our experience and expertise across all pharmaceutical areas potentially affected by the UK’s withdrawal, including Quality and Supply Chain Management, Regulatory Affairs and Pharmacovigilance, we are perfectly positioned to partner with clients in undertaking a systematic evaluation of their Company’s pharmaceutical distribution, development, regulatory and pharmacovigilance operational status with respect to Brexit. Under our continued guidance, the outcome of that objective analysis can then be translated into a formal plan for implementation in preparation for Brexit. As such, organisations can be confident that they are taking constructive steps and assure their stakeholders that they are prepared and acting in a measured and timely manner. If you would like to discuss your requirements in relation to Brexit-planning, please contact us at +353 1 846 47 42 or contactirl@pharmalex.com