EU Based QPPV – Is Your Company Ready for Brexit?

As Brexit negotiations reach their most critical point, it looks today (October 17th, 2019) that a deal is in sight.  The EU and the UK have agreed a deal and the UK Parliament are now set to vote on the deal on October 20th. Therefore, companies that have not yet arranged for an EU based QPPV must do so urgently.

Our team of EU based QPPV’s can help.

The UK as a Third Country

When the UK finally leaves the EU, it will be classed as a third country by the EMA. It is inevitable that if the EU QPPV resides in the UK you will be affected by Brexit and the UKs decision to leave the EU. The demand for QPPVs is putting severe pressure on all UK MAHs with products in the EU. The demand has lessened the availability of EU QPPV resources throughout the EU, a fact that each MAH needs to be aware of.


Therefore, companies that have not yet arranged for an EU based QPPV must do so urgently. And our team of EU based QPPV’s can help.

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”.

Would you like to learn more about our Pharmacovigilance Services?

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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