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.
And 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.
Today, the EU has said that there will be no ‘prolongation’ if the UK’s Parliament does not accept the deal.
NEW: President Juncker says no prolongation – sounds like no extension
“We have a deal, why should we have prolongation”
— Nick Eardley (@nickeardleybbc) October 17, 2019
(Source: Twitter.com – Nick Eardley, BBC)
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”.