Brexit

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

Brexit

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 in May 2017 have provided an indication of the changes that the Pharma and Biotech industry may need to consider to meet the new situation. For EU/EEA licenses there will probably be an impact on the Marketing Authorization Holder (MAH) and pharmacovigilance activities.

If you consider that your company may be impacted by these changes we recommend that you begin to prepare a risk management plan ahead of the March 2019 timeline.

Several topics which could be impacted include:

  • UK is/or will be the RMS – For medical 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 in the UK – The MAH will need to transfer its current UK batch release site 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.
  • Generic/Hybrid type of application.

Over the last few months 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 management plans 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 will explain in a little 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 there is talk of a soft or hard Brexit it seems that Brexit in some form will happen and we are ready to help you.


Have a question concerning Brexit? Contact us