Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders (MAH) must have an appropriate and qualified person responsible for pharmacovigilance (EU-QPPV) domiciled or located within the European Union. Also, the EU pharmacovigilance framework establishes the opportunity for the National Competent Authorities (NCA) of the EU to request the nomination of a contact person for pharmacovigilance (PV) issues at a national level.
Such individuals are typically required to speak the local language and to reside within the given Member State and should have a direct reporting link to the EU-QPPV. Among the industry, such persons responsible for PV on county-level may be referred to as the: Local Qualified Persons for Pharmacovigilance (Local QPPV / LQPPV / National QPPV), Local Persons for Pharmacovigilance (LPPV), National Responsible Persons for Pharmacovigilance (NRPPV), Local Contact Persons for Pharmacovigilance (LCPPV). Local Safety Officers (LSO), etc. Despite of different titles used to describe these persons, they all typically represent the same role and responsibility towards representing a MAH on country-level regarding PV issues.
Most of the EU Member States have implemented the requirement to nominate a PV contact at a national level in their national legislation. These requirements vary between Member States, ranging from a requirement to nominate simply a local contact person speaking the local language, to more stick requirements, where a local person holds legal responsibilities and should be empowered to influence the overall MAHs PV system.
|EU Member State||Is a local PV contact person (LPPV / Local QPPV / LCPPV) required?||Requirements for the Local PV Persons Qualifications||Comments and Legal refferences|
At Insuvia, we specialize in local service provision and country-level PV operations. We guide our clients in setting-up PV activities country-wise as well as act as their local PV resources (LPPV, Local QPPV, EAEU-QPPV, etc.) handling routine PV activities on ongoing basis. Click hear to view all our local PV services or contact us to explore the regional and local PV requirements in the territories we are experts in, as well as to discuss the potential ways how these requirements could be fulfilled with our help.