Brexit and relocation

Move to Amsterdam

In January 2020, EMA relocated to its new permanent headquarters in the Zuidas business district of Amsterdam. This marked the end of the Agency’s physical relocation from London to Amsterdam, which had started in March 2019 in a temporary building in Amsterdam Sloterdijk made available by the Dutch government.

EMA’s permanent premises, a tailor-made building with approximately 33,000 square metres and 1,300 working spaces, was commissioned by the Dutch government and built by the Central Government Real Estate Agency (CGREA) with a consortium of construction companies. The building was completed in record time: it took a little over two years between the decision in November 2017 of the EU Member States to relocate EMA to Amsterdam, following the United Kingdom’s decision to leave the EU, and the move-in of EMA staff at the beginning of January 2020.

At the beginning of February 2020, EMA staff gathered in the lobby to raise again the EU flags, thus closing the chapter of its relocation to the Netherlands.

Preparing for Brexit

The UK formally left the EU on 31 January 2020 and became a third country (a country outside the European Union and European Economic Area). The EU-UK Withdrawal Agreement provided for a transition period ending on 31 December 2020, during which EU pharmaceutical law continued to apply to the UK. Throughout 2020, the UK therefore continued to receive all documentation from EMA procedures, and the procedures carried out at EU-level applied to the UK. The UK also kept access to all EMA systems and databases.

The most immediate change of the UK’s departure was that as of 1 February 2020, delegates representing, appointed by or nominated by the UK could no longer participate in any EMA scientific committee or working party meetings, or in the Agency’s Management Board.

As part of Brexit preparedness planning, EMA and the EU27 Member States had anticipated the loss of UK experts in their day-to-day operations. Since July 2019, the portfolio of medicines previously managed by the UK was already fully under the responsibility of new rapporteurs and co-rapporteurs from other EU Member States, Iceland and Norway.

From May 2017, EMA, the European Commission and national competent authorities in Member States worked closely together to minimise the impact of Brexit on the supply of medicines. This work continued throughout 2020 as the end of the transition period drew to a close. Companies were advised on how to apply for and implement the necessary regulatory changes so that their medicines could remain on the EU market after Brexit and were encouraged to plan and take action early.

By November 2020, as was required to ensure a smooth transition, all MAHs for centrally authorised medicines previously based in the UK had moved to an EU Member State. Most MAHs had made the necessary changes, notably as regards the relocation of qualified persons for pharmacovigilance (QPPVs) and pharmacovigilance master files (PMFs), by the end of 2020. Thanks to early planning and good anticipation of the changes needed, no medicine shortage occurred.