What Will Happen To The QPPV Post Brexit?

Brexit will impact on many aspects of the life sciences sector.  One of the areas that will be most impacted will be the role of the Qualified Person for Pharmacovigilance (the QPPV).  In this article, we consider the impact that the UK’s exit from the EU will have on the role and the measures that companies will need to take once Brexit happens.

As per DIR Art 104 (3) the Qualified Person for Pharmacovigilance (QPPV) shall reside and operate in the EU. Following EEA agreements, they may also reside and operate in Norway, Iceland or Liechtenstein.

But what will happen to the QPPV post-Brexit? Well, the short answer is in the question “exit” (at least for now).

The European Medicines Agency (EMA) Questions and Answers related to the UK`s withdrawal from the EU regarding the medicinal products for human use, provides guidance on the role of the QPPV post-Brexit. As it stands:

UK QPPV

Any QPPV currently residing in the UK will need to change his/her place of residence and carry out his/her tasks in the Union (EEA) or a new QPPV residing in the Union (EEA) will need to be appointed.

UK Deputy-QPPV

As the tasks of QPPV need to be carried in a Member State of the Union (EEA), the back-up arrangements for cases of absence of the QPPV, which replace such tasks, also need to be performed in the Union (EEA).

UK Pharmacovigilance System Master File (PSMF)

According to Commission Implementing Regulation (EU) No 520/2012, the PSMF must be located within the Union (EEA), subsequently, the marketing authorisation holder will need to change the location of the PSMF to a Member State within the Union (EEA).

Brexit brings an uncertain future for UK based QPPVs and considering the above they potentially have one of three options:

  • relocate,
  • change position, or
  • accept redundancy

Last year the EMA launched a survey to gather information from MAHs about their preparedness for Brexit. Of the 1165 human medicinal products registered centrally with the EMA, 427 of these have been registered by a UK-based MAH and 323 utilise UK QPPV services. The survey showed that the UK has a large talent pool of PV professionals and various questions remain for UK based QPPVs that can’t relocate. Additionally, given that the area is so niche, the increased demand of QPPV services will put severe pressure on the recruitment industry.

Our Recommendation

The only thing that we can say for certain about Brexit at this moment (July 2019) is that no one really knows what the relationship between the UK and the EU will be and what implications that will have. However, we are recommending that all MAHs affected by Brexit have a plan in place and  carefully assess where in the post-Brexit EU the QPPV and PSMF will be established. Also, whatever your plans and changes in QPPV, make sure details are updated in Article 57 database!

If you would like to speak to us about issues surrounding the above or seek our advice then call us on 00353 52 61 76706, email us: info@acornregulatory.com or complete the webform below and we will get back to you.

About the Author
Natasha Daly
Pharmacovigilance Manager
Natasha joined Acorn Regulatory in October 2018 as Pharmacovigilance Manager. Natasha has over 11 years’ experience in the pharmaceutical industry. Her experience comes from working in a large global innovator pharmaceutical company and a large global generic company and includes drug development, post-marketing and clinical trials. Natasha`s role as pharmacovigilance manager at Acorn Regulatory is intended to ensure that the procedures in place are adhered to and that Acorn Regulatory provides a quality of service to its clients acceptable to any inspecting authority. You can read more articles by Natasha Daly clicking the link below.
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