The Essential Guide To Local Person For Pharmacovigilance

Every marketing authorization holder (MAH) needs a pharmacovigilance system to ensure product safety. In Europe, the Qualified Person for Pharmacovigilance (QPPV) is central, but many countries also require a Local Person for Pharmacovigilance (LPPV) to report to the QPPV. EU legislation outlines QPPV roles, while LPPV requirements vary by country, leading to significant differences. Directive 2010/84/EU and GVP Module I provide guidance, but national laws detail LPPV requirements.

Differences include whether an LPPV is required, their titles, timing of appointment, language proficiency, country residence, education, availability, and the need for a deputy. These variations complicate setting up a PV system for products marketed across multiple countries.

It is crucial to understand these regional requirements well in advance. For support, access the full article below.