Brexit consulting: From a regulatory perspective, what does it mean for Britain to leave the EU?

Based on the referendum from June 23rd 2016, the United Kingdom has unfortunately decided to leave the European Union. The regulatory implications for UK and EU based companies are still uncertain and will be discussed during the transition period until 2018. A full "Brexit" would have a significant regulatory impact on the pharmaceutical industry. 


Proppert Solutions GmbH provides

  • regulatory consulting services regarding the "Brexit" as well as 
  • complete solutions (see below) for UK and EU based companies in order to ensure that medicinal products can remain on the market and that the transition period will be as smooth as possible.


Unless the UK negotiates agreements to maintain most privileges foreseen for members of the European Union or European Economic Area, a number of "Brexit" consequences should be expected:

  • UK based companies holding marketing authorisations for EU countries would likely be required to transfer the authorisations to an EU affiliate or EU legal representative. According to the EU Directive 2001/83/EC, the marketing authorisation holder must be located in an EU/EEA member state.
  • For products authorised via DCP or MRP procedures involving the UK, the UK and EU marketing authorisations might need to be maintained separately in future. If the UK authority MHRA was involved as RMS, the role of the RMS would need to be transferred to a national authority in the EU. There will be similar implications for products that were authorised via the centralised procedure.
  • The EU QPPV is required to be resident in an EU member state. An additional QPPV might be required for the UK.
  • The UK and EU might sign a mutual recognition agreement similar to the agreement established between the EU and Switzerland in order to at least recognise UK/EU GMP certificates and ensure that manufacturing of the dosage form could be performed either in the UK or EU. Still, a separate batch release for the UK and EU market would be required. Companies would be required to establish a GMP manufacturing site in the UK, where batch release for the UK is performed by a UK Qualified Person, and an additional GMP manufacturing site in the EU, where batch release for the EU market is performed by the EU Qualified Person. A manufacturing authorisation, which could be limited to performing batch release, would be required for each site. 

EU virtual affiliate services / services as EU marketing authorisations holder (EU representative)

We are providing complete solutions for marketing medicines in the European Union, taking care of all pharmaceutical responsibilities and activities. We can establish and manage your EU virtual affiliate (EU marketing authorisation holder, MAH) so that medicinal products can be marketed in the European Union under your own company's name. Alternatively, Proppert Solutions GmbH can act as EU marketing authorisation holder (EU MAH, EU legal representative) and market your products based on a trust agreement.


Our virtual affiliate services include:

  • Establishing a legal entity in the EU, serving as Managing Director or CEO, providing an office address, ensuring availability via phone and mail and managing all business activities.
  • Regulatory Affairs: Managing all regulatory activities in the EU, e.g. application procedures and variations.
  • Pharmacovigilance: Proppert Solutions GmbH provides the services of an EU QPPV, who is resident in the EU. We are also performing all pharmacovigilance activities, e.g. case review, reporting to EU authorities, maintenance of the PSMF.
  • Medical information: Our pharmacists and doctors are continuously available to answer medical inquiries from patients and health care professionals.
  • GMP/GDP Quality Assurance, Manufacturing, Batch release: Proppert Solutions GmbH has significant experience in establishing GMP & GDP quality systems and managing applications for manufacturing authorisations wholesale distribution authorisations. We are also providing the services of a Qualified Person (QP) responsible for batch release and GDP Responsible Person. In the EU, the company performing the final batch release will be considered the legally responsible manufacturer. A manufacturing authorisation limited to performing the final batch release will be sufficient for this purpose. Manufacturing of the dosage form can be outsourced to contract manufacturers.