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EMA Move

It’s decided. The EMA is moving to Amsterdam, The Netherlands.

They are supposed to be up and running by March 30, 2019 – less than two years away. There are many issues to be resolved by then. In fact there are many issues to be first defined before they can be resolved. To this end several groups have already started the discussion.

Before reading on, have a look at the 3-minute promo video the Dutch did in their bid for the EMA.  It is quite amusing actually.


EMA’s Comments on Brexit

First the EMA: The EMA published comments on Brexit. This is EMA’s dedicated page regarding Brexit and it should be checked regularly as it will be updated periodically. In this document the EMA notes that they will start immediately working with the Dutch government to set up a joint governance structure to oversee the relocation. In December, a monitoring chart will be published to allow the public to track progress.

The UK will continue to participate in the activities of the EMA till Brexit is done. The UK will become a “third country” after March 2019. That is, it will not be a part of the EMA or EU and will be treated like any other third country (Author’s comment: maybe). Discussions on this have been underway since April 2017 on how to redistribute the current workload after the UK leaves. A working group on human medicines has been set up and includes members of the CHMP and PRAC.  They are working on mapping capacity and expertise (not all member states have equal expertise or manpower), decision making and communication to stakeholders. This document, at the very bottom, has several appendices on the technical issues regarding the physical building and other things the EMA will need in Amsterdam.


Information for Companies

The EMA and European Commission have published some documents on “Information for Companies”.  The goal is to ensure an undisrupted supply of medicines to the public.  A Q&A was published in December. Some of the key points:

For decentralized and mutual recognition issues see: https://www.hma.eu/535.html.

Another document was issued in November giving details on how many of these changes are actually to be done. See the document for full information on these regulatory matters.


Business Continuity Plan

In October, the EMA published a Business Continuity Plan. It includes information at a high level on ensuring the continuity of EMA’s work. They note it can no longer be “business as usual” as too many things are happening. They are preparing to maintain current staffing but proposing certain “entitlements” to current staff to retrain them and help them move to Amsterdam. They will recruit additional resources as needed over a prolonged time to compensate for staff loss. The EMA is also prioritizing their activities into those which must be done and those which are of a non-strategic character. This will entail setting up a temporary situation whereby not all activities will be done as they are now.  Once things are tidied up, they will, in a stepwise manner, have a gradual uptake of all activities.

The highest priority activities are core scientific ones as well as supporting IT applications and communications necessary for the operation of the EMA. Also included are activities to ensure a stable income. Finally the legal obligations that must be done are high priority.

Lower priorities include certain maintenance activities, scientific advice and certification, pediatric activities not linked to specific procedures and processes and others.  See the document for more details.

There will be three categories of work: business as usual for some activities, suspension of some activities and reduced output (slowdown) of other activities.

This is a seventeen page document with much detail and if you work with the EMA in your job, it is worth looking at this document.



Well, the companies and industries are reacting to a situation most of them never wanted and many never envisaged. Most of the reactions are fairly obvious in that the industry in Europe and the UK wish for a smooth transition and total cooperation among all parties.

There are several very visible issues pending now including a lease for the London EMA building that will run till 2039 with $470 million due. The problem is that there is no clause that lets the EMA break the lease.  So someone may have to pay hundreds of millions of dollars (euros, pounds) for the non-use of the London EMA building.

Another issue is that the new EMA building in Amsterdam will not be ready till late 2018 or even 2019. This means temporary lodgings for the EMA in Amsterdam, probably in several smaller buildings, in 2018 presuming they want to move sooner rather than later. Then another move would be needed in 2019 when the new building is ready.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) put out a statement along with several other EU and British industry groups.  Their key points are:



We are looking at a very messy situation. There are now about 15 months left to get the EMA set up in Amsterdam. The building (a building) must be ready, IT in place, personnel (~900) transferred or newly hired, etc. As with any large-scale corporate or governmental move, there is much work to be done between now and March 2019.  Also, as with any move, there will be bugs, problems and issues to resolve after going live.

Keep in mind that there may be two efforts required for everything:

The things to look for will be:

Things to look for regarding pharmacovigilance and drug safety:

This will be interesting!


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