Exploring the roles of the
UK QPPV and National Contact Person (NCP)
and how JensonR+ can support you

What is a QPPV?

Every marketing authorisation holder is legally obligated to have a Qualified Person for Pharmacovigilance, known as a QPPV, to oversee the drug’s pharmacovigilance

This is not just a requirement for marketed medicines. Regardless of marketing status, all marketing authorisations must have a QPPV assigned from the point of application.

Ultimately, the QPPV is responsible for the governance and compliance of the entire PV system.

EU or UK QPPV?

Before Brexit, the MHRA almost completely synchronised to EMA GVP guidelines. As a member state, a QPPV residing in the UK was recognised in the EU and could act as EU QPPV.

Following Brexit, GVP guidelines were written into UK law meaning the EU and UK regulations are still very much aligned. In the transitional period, negotiations around the authority over Northern Ireland have created new roles and responsibilities for UK MA Holders. Most notably the creation of the UK QPPV and UK NCP.

Currently, QPPVs residing in the UK can no longer act as QPPV for EU licences. Vice versa was true for QPPVs residing in the EU.

This means for any UK, GB or Northern Ireland specific licence, a UK QPPV is required to be nominated. They may reside in the UK, or EU providing an NCP in the UK is nominated.

Northern Ireland challenges

For a UK licence, covering England, Scotland, Wales, and Northern Ireland, the EU continues to recognise Northern Ireland (NI) as being in the EU and therefore mandates oversight for that territory.

With both the EMA and MHRA requiring oversight of Northern Ireland, how do we overcome this?

Solutions

Currently, there are 2 different options to remain compliant with UK law:

  1. The MA has 2 QPPVs, a UK QPPV covering the UK (including Northern Ireland) and an EU QPPV covering Northern Ireland only.
  2. A QPPV resident in the EU covers the entire UK licence and acts as both the UK and EU QPPV

If option 2 is chosen, the MHRA requires a person situated in the UK to be nominated as the MHRA’s point of contact. This is known as the National Contact Person (NCP).

NCP roles and responsibilities

An NCP must:

  • reside in the UK
  • report to the QPPV and be the main point of contact for the MHRA
  • have access to adverse event reports for the concerned MA
  • have access to the latest version of the PSMF

This is provided for by regulation 182 of the Human Medicines Regulations 2012 (as amended) (HMR).

JensonR+ has an in-house team of pharmacovigilance experts and dedicated UK and EU QPPVs. Our pharmacovigilance team can also provide NCP services.

“Our experienced team can provide a flexible and bespoke pharmacovigilance service designed to meet the complex and changing needs of the global environment.”

 Find out more on how our pharmacovigilance team can support you
James Hall