To ensure the safety of their products Marketing Authorization Holders (MAHs) must have well-developed pharmacovigilance (PV) system in place. The launch of the PV system in the European Union (EU) requires the designation of the EU-QPPV, a person responsible for establishing and maintaining the PV system. In addition to the EU-QPPV, part of the National Competent Authorities (NCAs) of the EU member states require MAHs to appoint a local contact person for PV issues at the national level (local person for pharmacovigilance). Different titles are used by companies to describe this role of a local person for PV, such as LPPV, LCPPV, local QPPV, and others. For this review, we will use the term LPPV to describe this role.
As we discussed in our recent article, the requirements for the local person for pharmacovigilance (LPPV) vary greatly between EU member states. Navigating through these requirements may become a great burden for some pharmaceutical companies. Especially those who are just planning their first Marketing Authorization (MA) application submission in the EU and have little or no experience in dealing with the PV requirements that apply across EU and country-wise in its member states.
Within this article, we aimed to provide on some of the most important considerations for the LPPV strategy across the EU countries. These strategic considerations can help familiarize with the differences between the national requirements for LPPVs and take them to your advantage, as well as provide some insight on how these requirements could be met most efficiently without allocating excess resources and cost. In particular, we will discuss how to make sure that you: 1) appoint the LPPVs where you have to; 2) locate the LPPVs in the best location; and 3) nominate the local person for pharmacovigilance (LPPV) at the right time.
Through careful planning and an appropriate LPPV strategy, MAHs may not only assure that they fulfill all the country-level PV requirements, but they can also build an LPPV network that is optimal and results in saving resource and cost.
It is important to note that this review does not cover all of the requirements (e.g. requirements for LPPV education, 24/7 availability, etc.) that should be taken into account. We have discussed these requirements in detail in our recent article.
We specialize in local service provision and country-level pharmacovigilance services. We can advise and guide you in setting-up PV operations country-wise in the most effective way. We provide Local Persons for PV (LCPPV, LPPV, local QPPV) in: European Countries (EU/EEA), Russia / EAEU & CIS countries, and Middle East & North Africa (MENA). Click here to view the full list of territories we cover.
This is just one of the pharmacovigilance services provided by Insuvia, click here to explore other services.