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EMA and Brexit Yet Again Part1

EMA and Brexit Yet Again: Part 1


The saga of the withdrawal (Brexit) of the United Kingdom from the European Union continues. There is enormous turbulence in the UK over this issue with the (Conservative) government in power under Prime Minister May fighting everybody to finalize a Brexit agreement. The Conservative Party is divided and in turmoil over the issue as is most everybody else in the UK and Eire (Ireland). Although there have been many discussions and negotiations between the EU and UK there remain many issues still to resolve. The details are arcane and byzantine. The costs in time lost on this from regular work as well as money are enormous.

The EMA has 2 Brexit websites:

Check them periodically as they are updated frequently. The bottom lines, though, are this:

Nobody knows yet what will happen:

The bottom line is that there is no bottom line yet!

This has major implications for the UK, the EU, Ireland (which has the only land border between the EU and UK) as well as “third countries” such as the US, Japan, China and others active in the pharma world.

To a large degree the various agencies of the EU (such as the EMA) are being left on their own to work out what will/may happen after March 30, 2019. This is a moving target and the EMA continues to issue periodic documents and announcements relating to pharma.


Several documents regarding Brexit and the EMA have been updated. Here is a summary of the key points with emphasis on PV and drug safety. Most have the new contents labeled as “NEW”.

EU Q&A from the European Commission

The EU Q&A has been updated as revision 3 on June 19, 2018.

EMA Practical Guidance on Brexit

This document has also been updated as revision 2 on June 19, 2018.

Industry Survey

The EMA carried out a Brexit readiness survey in 2018 of over 180 MA holders for 694 centrally approved human and veterinary medications located in the UK. The results were published in July 2018

The main findings touching safety and PV are:

Regulatory Preparedness

In April 2018 the new Rapporteurs and Co-Rapporteurs were informed of their new duties on the 370 centrally approved products now in the UK. In September the knowledge transfer package with each product containing background knowledge on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment, will be sent to the new Rapporteurs and Co-Rapporteurs.

The EMA business continuity plan was issued in October 2017 and indicates how activities will be prioritized. This was discussed in an earlier posting here.

An update to this plan with “final programming” and goals was issued in December 2017. This will be discussed briefly in the next Bart’s Corner as Part 2. The document is 153 pages long!

The next phase of this plan is due to come into effect in October 2018 to “enable staff to cover critical functions”. EMA also indicated that it will monitor the situation to see if there are higher staff loses than anticipated.


Although all the people involved in the EMA Brexit situation are working hard to make the move as well as possible, it is clear that this is, to put it kindly, a challenge and, to put it less kindly, a mess.

As implied in the statement that there might be higher staff losses than anticipated (the scuttlebutt seems to agree with this), the move of the EMA to Amsterdam is an enormous effort. It is akin to refueling a jet in the air. The key functions must continue during the transition. It is highly likely that there will be some adventures and MA holders in the EU and elsewhere must prepare plans to transition their obligations to the new EU Rapporteurs and Co-Rapporteurs, move the QPPV and backup and PSMF if necessary. Companies should also prepare for the worst-case scenario. Although there might be a last minute extension of the March 2019 deadline one cannot count on this.

For US companies with partners or CROs in the EU, you should be in close touch with them to be sure they are handling your product(s) correctly and that the needed paperwork, transfers, etc. are being done. You may want to consider an audit or gap analysis of the what is being done by your partners in the EU and UK.

Stay tuned.

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