April 22, 2020
Local Person for Pharmacovigilance (LPPV) Strategy Considerations in the EU
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 the role of a local person for PV, such as LPPV, LCPPV, local QPPV, and others. We will use the term LPPV to describe this role for this review.
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 some of the most important considerations for the LPPV strategy across 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.
- Where are LPPVs truly required? To begin with, you should clarify in which countries it is truly required to designate an LPPV. In some countries, the LPPV appointment is strictly required. Some countries have reserved a possibility to request LPPV nomination in individual cases when they deem required. Whereas part of the EU member states has no requirement for LPPV at all. We have summarized the requirements for LPPV nomination in each EU country in our recent review to help you with this step;
- Are there any exemptions possible in a country? Secondly, you should review all exemptions that may be possible in each country. For example, if you hold a single licence for a centrally approved product (e.g. an orphan medicinal product) that you do not market in a country yet, you may be fully exempt from the requirement to nominate the LPPV;
- When is the LPPV required? Next, you should take into account from what time point the appointment of an LPPV is required. Depending on the country’s requirements, LPPV nomination may be required right upon submission of the Marketing Authorization (MA) application, upon MA approval, upon the first launch of the product or even only when some specific circumstances exist e.g. when risk minimization materials have to be distributed in the country. Of course, MAHs must make sure they nominate the LPPVs in due time, however at the same, hiring and nominating the LPPVs before you need to may be redundant and result in unnecessary cost.
- Deputy person requirements. Pharmacovigilance requires to assure business continuity and, by default, MAHs should have Deputy persons in place for each LPPV they appoint. In some countries, this is also implemented as a clear legislative requirement. However, taking the language and residency requirements into account (as described in the previous step), in some cases the wisest strategy may be to have the primary LPPVs in two countries backing up each other, thus avoiding the need for Deputy persons based in each country;
- Language & residency requirements. All Member States where the LPPVs are required requires them to speak the local language of the country. One other common requirement is that the LPPV should reside in the country where he/she carries out the PV activities, however, this is required only in part of the countries. Taking this into account and given the fact that some EU countries have the same (e.g. Germany & Austria) or essentially similar (e.g. the Czech Republic & Slovakia) language, with an appropriate strategy in place, MAHs may fulfil the LPPV requirements with a single LPPV covering a couple of countries.
Through careful planning and an appropriate LPPV strategy, MAHs may not only assure that they fulfil all the country-level PV requirements, but they can also build an LPPV network that is optimal and results in saving resources 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 the 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.
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