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There have been several events occurring in the EU/Europe that will play on pharmacovigilance. One that we’ll address here is the vote by the United Kingdom (UK) to leave the European Union (EU).


In late June 2016, the UK voted to leave the EU. A new government has been installed with the Prime Minister and government accepting and implementing the vote to leave. It is likely the process will take at least two years and possibly longer. It is unclear how the divorce will play out. Clearly, the UK is part of Europe and will set up new or altered trade, banking, immigration, pharmaceutical and many other processes with the remaining 27 member states of the EU as well as with individual countries – particularly the US, Canada, Australia, New Zealand and India. No one knows how this will all play out.

What the EMA and MHRA are Saying About Brexit and Pharmaceuticals

The EMA has released a statement and the issue was also discussed at the recent June DIA annual meeting. See the various reports including:

The EMA itself issued a statement indicating:

“…it is now up to the UK government to decide how to act upon the outcome of the referendum.

EMA would like to underline that its procedures and work streams are not affected by the outcome of the referendum. The Agency will continue its operations as usual, in accordance with the timelines set by its rules and regulations.

No Member State has ever decided to leave the EU, so there is no precedent for this situation. The implications for the seat and operations of EMA depend on the future relationship between the UK and the EU. This is unknown at present and therefore we will not engage in any speculations.”

Some Things Do Seem Likely, In My View:

Some Things are Less Clear.  Here is Some Speculation:

What to Do Now:

Pharmacovigilance is always an area of uncertainty where the next email or phone call can herald a major drug problem or crisis. This merely adds to our exciting workload!


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