Brexit, and now…. ?

By 4. July 2016Blog

On 23rd of June this year the very surprising result of a referendum in the UK was broadcasted. With a small majority, Britain voted to leave the European Union, which leads to several regulatory related questions:

  • Are there any immediate actions every regulatory professional need to take care of?
  • What regulatory implications do we have to start preparing for mid term ?
  • What different types of exit scenarios are possible ?
  • What are the implications for a distributed EU wide manufacturing setup ?
  • What will happen with EMA related activities ?
  • Will EMA remain in the UK ?
  • What will be the status of MHRA in cooperation with other European NCA’s ?
  • And more…..

At the moment we cannot answer these questions in detail. What we can do, and this is our recommend best practice approach, is to establish a company internal task force, with the current objective to list all possible implications and questions.

EMA recently published an update in which is described, that since this never happened before, there are no fixed procedures and for now everything remains untouched. However, there will be some challenges.

EMA

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002566.jsp&mid=WC0b01ac058004d5c1

 

The recently published EFPIA statement might also be helpful.

EFPIA

http://www.efpia.eu/mediaroom/350/43/EFPIA-Statement-on-Brexit

 

Bloomberg published a valuable article about the opinion of Severin Schwan (Roche Holding AG Chief Executive Officer) in this matter:

http://www.bloomberg.com/news/articles/2016-07-21/roche-ceo-worried-about-u-k-drug-research-following-brexit-vote

 

In summary we can state with confidence, that there is a lot of work ahead, but for now there are no immediate actions required other than information gathering.

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Kind Regards,

Your Cunesoft Team

Rainer Schwarz

Author Rainer Schwarz

Cunesoft CEO - He has over 15 years of experience with compliant software solutions for regulated processes. He worked in senior management positions at CDC Solutions, Liquent and NextDocs. He has a master degree of Social Sciences from the University of Innsbruck and Hong Kong University

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