The Pharma and Biotech industry is likely to be significantly affected by Brexit. We can help you prepare with a range of personalised services.

- Dr. Jürgen Regenold Managing Director


The Pharma and Biotech industry is likely to be significantly affected by Brexit. The joint notice and Q&A document from EMA and European Commission along with the CMDh have provided an indication of the changes that the Pharma and Biotech industry may need to consider to meet the new situation when UK will be a “third country”. For EU/EEA licenses there will be an impact on the Marketing Authorization Holder (MAH), testing and release facilities and pharmacovigilance activities.

On 29 October 2019, the European Council agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 January 2020.

If you consider that your company may be impacted by these changes we recommend that you begin to prepare for Brexit by performing the appropriate regulatory activities based on a risk evaluation ahead of the January 2020 deadline.

Several topics which could be impacted include:

  • UK is/or will be the RMS – For medicinal products authorized/planned to be submitted via MRP/DCP the company will need to change the location of the RMS to an agency of a member state of the EU (EEA).
  • Marketing Authorisation Holdership - MAHs located in the UK will need to transfer their EU MAs to a holder established in the EU (EEA) and for a UK license a UK located MAH will be needed.
  • Batch release site(s) in the UK – The MAH will need to transfer its current UK batch testing and release site(s) to a location established in the EU (EEA) whilst for a UK license a site in the UK is required.
  • PV - PSMF & QPPV location must be inside EU/EEA for EU27 whilst for the UK the PSMF & QPPV location must be in UK.
  • Impact on Generic/Hybrid applications types in relation to the choice of reference medicinal product for BE studies.

Over the last couple of years, we have been assessing with some of our clients the different options and alternatives to address these issues. Some clients are affected more than others and we have been helping them prepare individual risk evaluations, as necessary. We have offices throughout the EU and UK, as part of our regulanet® network, and are therefore able to understand the issues and provide solutions dependent on your particular situation and strategy.

You can download the document Brexit: How to be prepared which explains in more detail the issues and potential solutions. Whatever your situation and wherever your legal entity is located within Europe, we are able to help you with tailored solutions with the help of our partners.

Whilst the no-deal Brexit appears to be less probable and there is uncertainty about the length of a potential transition period, it seems that Brexit, in some form, will happen and we are ready to help you.

Have a question concerning Market Access? Contact Thomas Gurney.