Pharmacovigilance (QPPV) provision post-Brexit

There has been and still is a huge amount of confusion regarding the requirements for establishing a UK QPPV following the UK’s exit from Europe on 31^st January 2020, creating challenges for pharmaceutical companies.

Pure Drug Safety is here to help you with what we know so far about QPPV provision post-Brexit:

Pharmacovigilance (QPPV)

If your current EU/EEA QPPV resides within an EU state then there is a temporary exemption in place, which allows 21 months beginning from exit day to allow you to appoint a UK QPPV that resides and operates in the UK.

However, if your current QPPV is UK based, then after  31^st December 2020, they  will not be able to act as a EU QPPV.

In the midst of this confusion, you can rely on Pure Drug Safety to help you make the transitions you need to enable you to carry out your QPPV tasks in the EU/EEA.

PDS already has a highly qualified and experienced team based in Europe who can be your:

• EU QPPV for Pharmacovigilance
• Deputy QPPV for Pharmacovigilance
• Responsible Person for Eudravigilance in clinical trials

Call us now on +44(0) 1476 512395 to discuss your Pharmacovigilance (QPPV) provision post-Brexit with one of our team.