In 2016, citizens of the United Kingdom (UK) voted in a referendum to leave the European Union (EU) by a slim margin. This departure, dubbed “Brexit” by the media, will have widespread implications for organizations that do business in the UK, especially those in highly regulated and technical industries. While all EU primary and secondary law will continue to apply to the UK until March 2019, when the withdrawal is planned for completion, pharmaceutical and biotechnology organizations must begin to prepare now for the changes that will occur.

To help address questions and concerns regarding the impact of Brexit on our industry, the European Commission and the European Medicines Agency (EMA) have jointly drafted the first in a series of Q&A documents entitled “Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure”.

This guidance is helpful for those looking for information related to changes in establishment requirements within the European Economic Area (EEA). A few key points discussed include:

  • Marketing authorization holders established in UK must be established in the EU. Through the EEA Agreement this is extended to also include Norway, Iceland, and Liechtenstein.
  • Likewise, an orphan designation holder established in the UK (for medicines for human use) needs to be established within the Union, by transferring the designation to a holder established in the EEA or by changing the place of establishment to a Member State of the Union.
  • Organizations that have a Qualified Person for Pharmacovigilance (QPPV) who currently resides and works in the UK will need to have his or her residence and place of work moved to a location in the EEA, or appoint a new QPPV to live in and carry out those tasks in the EEA.
  • At the date of the withdrawal of the UK from the EU, medicinal products manufactured in the UK will be considered imported, and thus will need to follow relevant import requirements.

While these considerations relate to the location of establishment of a company in the context of centralized procedures and certain activities, Brexit has many other implications for the pharmaceutical industry. We can expect to see further guidance documents from the EMA and the European Commission in the coming months to help prepare organizations for this significant shift more fully. We encourage you to download and examine these Questions and Answers if your organization or your partners conduct any business in the UK.

With advanced laboratories in both USA and Europe, BioAgilytix scientists have extensive experience working within the stringent requirements of diverse countries, and can provide bionalytical services including sample testing to UK sponsors on EU soil. To learn how we can help you effectively navigate regulatory complexity, speak to one of our scientists today.