The pharmaceutical markets of the Eurasian region are among the fastest-growing and most attractive globally for pharmaceutical and life sciences companies. This appeal stems from a combination of factors: a population of more than 290 million, steady growth in annual GDP, and the benefits of the free market economy within the Eurasian Economic Union (EAEU).
However, companies aiming to capitalize on these opportunities must stay fully aligned with the region’s evolving regulatory framework. This includes keeping pace with the latest pharmacovigilance (PV) obligations, such as those outlined in the EAEU Good Pharmacovigilance Practice (EAEU GVP). These guidelines cover the mandatory appointment of an EAEU Qualified Person for Pharmacovigilance (EAEU QPPV), as well as expectations around nominating Local Persons for Pharmacovigilance (LPPVs) within individual member states. Beyond the EAEU, pharmaceutical companies must also be aware of requirements to appoint local QPPVs or Local Safety Representatives (LSRs) in other Commonwealth of Independent States (CIS) countries. This article provides an overview of the legal framework for appointing a local person responsible for pharmacovigilance in the EAEU and CIS, with a focus on compliance expectations and practical considerations for Marketing Authorization Holders (MAHs).
The Role of the EAEU Qualified Person for Pharmacovigilance (EAEU QPPV)
The Eurasian Economic Union currently includes five member states: Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia. Pharmacovigilance obligations across these countries are harmonized through the EAEU GVP guidelines, which set out the core requirements for MAHs operating in the region.
Under these guidelines, every MAH must designate a Qualified Person responsible for Pharmacovigilance for the entire EAEU (EAEU QPPV). The appointment of this individual is central to ensuring compliance with the regional pharmacovigilance system.
The requirements for an EAEU QPPV closely mirror those established under the EU GVP framework. Key criteria include:
- Residency and presence: the EAEU QPPV must reside and work in one of the member states.
- Availability: the QPPV must be reachable at all times (24/7).
- Expertise: the QPPV must demonstrate solid theoretical and practical knowledge to oversee pharmacovigilance activities effectively.
- System management: the role requires proven skills in managing PV systems and either expertise in, or access to expertise in, relevant disciplines such as medicine, pharmaceutical sciences, epidemiology, and biostatistics.
Just as in the EU, only one EAEU QPPV can be linked to each pharmacovigilance system, making the position highly significant both strategically and operationally for MAHs.
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.
While most EAEU member states do not legally require Marketing Authorization Holders to appoint a Local Person for Pharmacovigilance, health authorities across the region often expect such a nomination in practice. This expectation has become a common regulatory norm even where it is not formally mandated. In Kazakhstan, however, the appointment of an LPPV is explicitly required by law.
For MAHs, this means that developing a compliant and efficient local PV strategy in the EAEU requires more than just knowledge of the written legislation. It also calls for an understanding of health authorities’ expectations and local practices to ensure responsibilities are met and compliance risks are minimized.
| Country | Is LPPV Required? | Qualification Requirements for the Local Person for Pharmacovigilance (LPPV) |
| Armenia | Expected | The NCA may require appointing an LPPV under EAEU GVP, and it is generally expected practice to do so by default, particularly if the EAEU QPPV is based abroad. |
| Belarus | Expected | The NCA may require appointing an LPPV under EAEU GVP, and it is generally expected practice to do so by default, particularly if the EAEU QPPV is based abroad. |
| Kazakhstan | Yes | The PV Responsible Person must reside locally, have a higher medical or pharmaceutical degree, and be continuously available to the authority. |
| Kyrgyzstan | Expected | The NCA may require appointing an LPPV under EAEU GVP, and it is generally expected practice to do so by default, particularly if the EAEU QPPV is based abroad. |
| Russia | Expected | The NCA may require appointing an LPPV under EAEU GVP, and it is generally expected practice to do so by default, particularly if the EAEU QPPV is based abroad. |
Local Pharmacovigilance Requirements in CIS Countries Outside the EAEU
Unlike within the EAEU, where Marketing Authorization Holders must appoint a single region-wide Qualified Person for Pharmacovigilance and, in certain cases, nominate Local Persons for Pharmacovigilance (LPPVs) in individual member states, the situation in the broader Commonwealth of Independent States (CIS) is more fragmented. Each non-EAEU CIS country operates under its own national legislation, which means pharmacovigilance obligations vary significantly from one jurisdiction to another.
In CIS countries where pharmacovigilance regulations are already established, MAHs are generally required to appoint a Local Safety Responsible (LSR) – essentially a local QPPV – to ensure compliance with national PV systems. These individuals are expected to take responsibility for local safety monitoring and act as the main point of contact with health authorities. However, it is important to note that not all CIS countries have yet implemented comprehensive pharmacovigilance frameworks. In those cases, there are currently no binding national requirements to appoint a local QPPV or establish a formal PV system.
The following table outlines the requirements for appointing a local QPPV in CIS countries outside the EAEU, together with the key qualification criteria and role expectations.
| Country | Is LPPV Required? | Qualification Requirements for the Local Person for Pharmacovigilance (LPPV) |
| Azerbaijan | Yes | The Local QPPV must reside and work in the country, hold a higher degree in pharmacy, medicine, or a related field, have PV knowledge, and be available 24/7. |
| Georgia | No | There are no specific requirements for LPPV in Georgia. |
| Moldova | Yes | The Local QPPV must reside and work in the country and have sufficient theoretical knowledge and experience in pharmacovigilance. |
| Tajikistan | Yes | The LPPV must hold a valid pharmacist license and reside and work in the country. |
| Turkmenistan | No, but recommended | Although no official requirements exist, in practice it is recommended to provide a bilingual power of attorney along with a copy of the passport and a higher education certificate. |
| Ukraine |
Yes | The Local PV Responsible Person must reside and work in the country, be trained in PV, hold at least a bachelor’s degree in pharmacy, medicine, or a related field, and if not medically qualified, have documented access to a specialist with higher medical education. |
| Uzbekistan | Yes | The Local QPPV must have a medical or pharmacy background, PV work experience, reside permanently in the country, and a Deputy with the same qualifications must also be appointed. |
Insuvia specializes in pharmacovigilance operations at the country level. Reach out to our team to discuss regional and local PV obligations and discover how we can help you ensure full compliance in the most effective way.
