October 28, 2022
LPPV Requirements in EAEU and the Rest of CIS Countries
The pharma markets in the Eurasian region are among the fastest-growing and most commercially attractive markets for pharmaceutical and life sciences companies. The extremely high interest of pharmaceutical companies in these markets can be explained by the large region population (which is over 290 million), in proportion to the growing annual GDP, and, as well as the free market economy of EAEU. However, pharmaceutical companies seeking to reap the region’s benefits need to be entirely up to date with evolving legislation, which includes also the latest pharmacovigilance requirements, such as the requirement imposed by the Eurasian Economic Union Good Pharmacovigilance Practice (EAEU GVP) regarding the nomination of EAEU QPPV and LPPVs (Local Persons for PV) across EAEU, or even the requirements for nomination local QPPVs / LSRs across the rest of CIS countries outside of EAEU. In this article, we will introduce you to the legal requirements for the nomination of a local person for pharmacovigilance in the Eurasian region (EAEU and CIS).
The requirement to appoint a Qualified Person for Pharmacovigilance in the EAEU (the EAEU QPPV)
Eurasian Economic Union consists of 5 member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia). The legal pharmacovigilance system requirements of these Member States are described in the Eurasian Economic Union Good Pharmacovigilance Practice (EAEU GVP) guidelines. According to this document, the Marketing Authorization Holder must designate a Qualified Person responsible for Pharmacovigilance for the EAEU (the EAEU QPPV) in one of the EAEU Member States.
The requirements for EAEU QPPV are similar to those of the EU QPPV within the EU GVP framework. Similarly, only one EAEU QPPV can be assigned to one pharmacovigilance system, as well as it is required that the EAEU QPPV should:
- Reside and work in one of the EAEU member states;
- Be available 24/7;
- Have adequate theoretical and practical knowledge for the performance of pharmacovigilance activities;
- Have skills for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology, and biostatistics.
The requirement to nominate pharmacovigilance contact persons on a national level in EAEU member states (the LPPVs)
In addition to the EAEU QPPV, according to the EAEU GVP guidelines, the competent authorities of the EAEU member states may lawfully request the appointment of pharmacovigilance contact persons on the national level (LPPV). The EAEU LPPVs represent MAHs PV operations on country-level across the Member States of EAEU and are accountable to the EAEU QPPV. One of the LPPVs may also act as the EAEU QPPV, and this is quite a typical scenario for many MAHs and PV systems in EAEU, especially smaller ones.
It is worth mentioning that, although EAEU member states have transferred the LPPV requirements into their national laws, in practice, not all EAEU member states utilize the right to lawfully request LPPV appointment as provided in EAEU GVP.
Therefore, with the right regulatory intelligence and understanding of the expectations and practices of the health authorities, MAHs can develop efficient EAEU local PV system strategies, that could both save cost and assure all PV responsibilities are fulfilled. Contact us now to free advice on your EAEU local PV system strategy.
Requirements for the nomination of a local qualified person for pharmacovigilance (local QPPV) / Local Safety Responsible (LSR) in the rest of CIS countries
Unlike EAEU member states, where the MAHs are required to have a single EAEU QPPV region-wide (the EAEU QPPV) and may be required to nominate LPPVs across some or all EAEU member states, the remaining CIS countries (i.e. countries of the Commonwealth of Independent States) that are not part of the EAEU each act as a separate legal system with its unique pharmacovigilance requirements.
If a country belonging to the CIS region has its pharmacovigilance legislation in place, then the appointment of a Local Safety Responsible, the local QPPV, is usually required. However, some CIS countries still do not have pharmacovigilance legislation in place and consequently have no national requirements for pharmacovigilance or local QPPV exist.
Below we summarize which countries of CIS require the designation of a local QPPV and what requirements for the person’s qualifications apply.
At Insuvia, we specialize in country-level PV operations. Contact us to discuss the regional and local PV requirements and potential ways of how these requirements could be fulfilled effectively with our help.
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