Here’s how to prepare for Brexit regarding Pharmacovigilance/QPPV and Legal Representative requirements
Following two years of negotiations between the UK and the EU, the UK Parliament voted against the Brexit deal. If your company is based in UK, this may have profound impact on your clinical research programme and/or the marketing status of your medicinal product/s:
The European Medicines Agency (EMA) expects UK based companies to pro-actively prepare in order to avoid any disruptions in March 2019.
Get on board with FGK and start working with a company that is already operating on the continent!
Our Pharmacovigilance services for UK companies:
Marketing Authorization Applicants/Holders in the European Union are legally obliged to appoint a “Qualified Person for Pharmacovigilance (QPPV)” within the EEA and also locate their “Pharmacovigilance System Master File (PSMF)” there. After the Brexit, this will apply to all UK companies having their QPPV / PSMF within the UK.
Our Legal Representative services for UK companies:
Sponsor companies that are not based in the EU/EEA must appoint a legal representative when conducting clinical trials in the EU/EEA. After the Brexit this will apply to UK companies planning to continue their clinical trial activities outside the UK, in the EU.