Every marketing authorisation holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. When setting up a pharmacovigilance system in Europe, the Qualified Person for Pharmacovigilance (QPPV) is central to this system. However, many European countries also require a Local Person for Pharmacovigilance (LPPV) to report to the QPPV. While the requirements and responsibilities of a QPPV are laid down in EU legislation (article 23 of regulation (EC) No 726/2004), LPPVs are subject to their own national legislation. In practice, this means that there are plenty of differences between requirements for LPPVs of different countries. Not only in Europe, but also in the rest of the world, where other legislations may apply. In this blog, I will, however, focus on Europe.
EU legislation is not entirely silent about LPPVs. In Directive 2010/84/EU amending Directive 2001/83/EC, Article 104 says:
“4. Notwithstanding the provisions of paragraph 3, national competent authorities may request the nomination of a contact person for pharmacovigilance issues at national level reporting to the qualified person responsible for pharmacovigilance activities.”
GVP (Guideline on Good Pharmacovigilance Practices) Module I says something similar in section I.C.1.1.:
“In addition to the QPPV, competent authorities in Member States are legally provided with the option to request the nomination of a pharmacovigilance contact person at national level reporting to the QPPV. Reporting in this context relates to pharmacovigilance tasks and responsibilities and not necessarily to line management. A contact person at national level may also be nominated as the QPPV.”
So, the detailed requirements for different LPPVs for different countries must be found in their national legislation. Of course, it may be challenging for an MAH to examine all local laws. I would like to give you a rough idea of some of the differences.
There are many differences between national legislations, so when you market a product in multiple European countries, you need several LPPVs, all with their own requirements. Some examples are:
For all marketing authorisation holders, it is essential to have a functional PV system in place, which is also organized by having the right LPPVs in the right place at the right time. Unfortunately, due to the national differences, this is not as straightforward as it seems. So it is essential to gain knowledge well before your products actually enter the market.