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Guildford 14 June, 2017

During May 2017, the EC, EMA and CMDh published communications and questions and answers notifying Marketing Authorisation Holders (of centrally authorised medicine and nationally authorised medicines respectively) of their obligations in relation to Brexit.  The communications state that from 30th March 2019 the UK will be considered as a third country (i.e. outside of the EU).  According to the EC/EMA communications, centralised marketing authorisations held by UK entities would need to be transferred to an entity within another EU member state prior to the UK exit from the EU. Pharmacovigilance obligations must also continue to take place in an EU member state.

How does this impact our clients?

PrimeVigilance is committed to minimising any impact of Brexit on our clients. As the outcome of the Brexit negotiations are currently unclear and will continue over a two year period, we will be keeping a close eye on developments and will ensure timely action to ensure continued quality and compliance. Over the coming years, responsibilities of PrimeVigilance EEA QPPVs based in the UK will be smoothly transitioned to our EEA QPPV colleagues based in our EU offices (Frankfurt, Prague and Zagreb). We also offer assistance with selection of the new PSMF location, and the related choice of a new supervisory authority for EEA pharmacovigilance inspections.

Links to EMA and CMDh Brexit communication websites:

EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7

CMDh: http://www.hma.eu/535.html

About PrimeVigilance Ltd.

PrimeVigilance is focused on providing high quality pharmacovigilance, medical information and regulatory affairs services. We support pharmaceutical, biotechnology and generics companies in managing the global safety of their products from early clinical trial development through full post marketing activities. We have proven expertise and the international presence to assure clients that patients and products will be adequately protected. We have over 350 experienced professionals across all our offices in Europe, UK and the USA.

For more information please contact us at info@primevigilance.com