Yellow fever vaccine
22nd July 2019
What happens after Brexit for Pharmacovigilance and Regulatory?
12th February 2020
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 31st 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 31st 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
