Regulatory preparedness – implications of the UK leaving the EU

As you will be aware, Article 50 was triggered on the 29^th March 2017. Following this, negotiations will be commencing on the UK’s withdrawal from the EU.

Although at this stage, it is unclear what the UK’s future relationship or co-operation will be with the EU regulatory system for medicinal products, we believe it would be pragmatic for organisations, including Marketing Authorisation Holders, to start considering the potential consequences in readiness for March 2019 now.

With this stance also being suggested by the EMA, PharmaLex would like to offer clients an initial impact consultation which can be subject to on-going monitoring as the future becomes clearer. We would systematically examine your pharmaceutical distribution, development, regulatory and pharmacovigilance operations in and for the UK and EEA (European Economic Area). This impact assessment will highlight corresponding operations in specific context of your current and planned business objectives that could be affected by the UK leaving the EU and may require alternative arrangements to be put in place. We are offering this service to our clients in order that they can assure their stakeholders that they are following the advice to plan for all possible eventualities in an informed and organised manner. This process will ensure that they are prepared to act effectively as information concerning the future regulatory environment in the UK and how it interfaces with the EEA unfolds.

As an international organisation with offices in the UK as well as a number of other EEA (and international) markets, working with PharmaLex provides your company with the assurances of regional and local expertise. This global reach alongside the ability to provide scalable solutions, wherever regulations require them, means that PharmaLex is able to support clients at every stage of the product lifecycle and wherever they choose to pursue their business in a post-Brexit Europe. With our considerable local UK and EU regulatory and pharmacovigilance expertise, we also believe that the UK will grow in importance as a strategically advantageous position from which PharmaLex can serve its clients.

If you would like to discuss your specific requirements relating to the UK’s withdrawal from the EU, please contact us on uk@pharmalex.com or call +44 (0)1628 530554. Alternatively, subscribe to our eNewsletter where we will be providing updates as they become available.