The EU QPPV After BrexitAs 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 contained in one of the words 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 Based QPPVAny 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 Based Deputy-QPPVAs 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:
- change position, or
- accept redundancy