UK and EU QPPV and National Contact Person (NCP)

All Marketing Authorisation Holders should have at their disposal an EU Qualified Person for Pharmacovigilance (EU QPPV). This is a legislative requirement and a cornerstone in ensuring patient safety and compliance. The EU QPPV role is to oversee and provide guidance to the Pharmacovilance team and importantly, to the company.

JensonR+ can provide support for you by providing both EU and UK QPPV coverage. This means we do the heavy lifting and keep your company compliant. The EU QPPV has to be resident in the EU.

We can further support by providing support with a Deputy QPPV.

This service is available on a 24/7 basis, giving you peace of mind.

QPPV

Our PV system is robust, and we can work with you to help bring efficiency and simplicity to the process. Our QPPV’s and PV team are here to help and guide so taking the strain and reducing complexity where possible.

The effects of the UK leaving the EU by way of Brexit changed the Pharmacovigilance landscape. All European Marketing Authorisation Holders who have a UK marketing authorisation must have established what is termed as a National Contact Person for Pharmacovigilance (NCP) who resides in the UK and who reports to the QPPV.

The National Contact Person has a responsibility on behalf of the marketing authorisation holder in that they are the main contact person with the MHRA and interface back to the MA holder should:

It is a requirement to lodge the name and contact details of the NCP with MHRA. Once the NCPP has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal.

JensonR+ works in a way that we want to become one of your team and not just an external resource. By working closely together we can help map activities, guide and support and offer value.

Get in touch with us to find out more