In recent years EAEU countries have implemented new regulatory changes aimed at enhancing the control over the safety of medicines after their registration. On the 13^th of June 2024, Decision No. 29 of the EEC Council has come into effect, amending Decision No. 83 of the Eurasian Economic Commission Council dated the 3^rd of November 2016. As a part the post-marketing surveillance program, the inspectorates of the Union member states are now entitled to conduct inspections of marketing authorisation holders for compliance with the EAEU GVP requirements.

New Eurasian Economic Union (EAEU) GVP requirements oblige for mandatory QPPV and PSMF located in one of the EAEU member states and readiness for inspections on request from one of the EAEU health authorities.

During transition period in regulatory requirements from national to EAEU regulatory status, particular attention should be paid to the type of marketing authorisation of the products (i.e., national vs. EAEU), which would determine the applicable GVP legislation at the time of potential inspection request.

For example, statistical data from Kazakhstan authority pharmacovigilance inspections according to a national GVP show a high rate of failure and major . In particular, marketing authorisation holders (MAHs) are often surprised that the inspection is performed at the site of the MAH and place of global PSMF holding and not in Kazakhstan. Failure at GVP inspection may lead to serious consequences, such as marketing authorisation suspension or even termination.

Inpharmatis has significant experience in the field of pharmacovigilance and GVP inspection support in the EAEU countries. We have successfully implemented many post-marketing surveillance projects for leading pharmaceutical companies both nationally and in EAEU mode. Our experts have an in-depth knowledge of local legislation and regulatory requirements, allowing us to provide a high level of quality and reliability in the services we offer.

Inpharmatis offers a wide range of pharmacovigilance services, including:

• Establishment of robust EAEU GVP compliant PV systems, including offering EAEU PV system location in the selected by the Customer EAEU member state
• Provision of EAEU QPPV and LPPV services in each of EAEU member states, including all necessary local activities, such as local PV literature monitoring
• Adverse events: Collecting, analysing, and processing data on signals and adverse reactions to medicines
• Medical Information Services. Provision of dedicated phone and contact lines for MI Services in each of the countries, including combined for receipt of PV, Quality and MI requests
• PV Medical Writing. Development and submission of periodic safety update reports (PSURs) and risk management plans (RMPs) in accordance with EAEU, international and local requirements
• Conducting trainings online and off-line and providing consultations for pharmaceutical companies on EAEU pharmacovigilance and regulatory compliance
• Audit and inspection support. Conducting internal and external audits of pharmacovigilance systems to assess their compliance with EAEU GVP requirements and other international standards, as well as support in organisation and performance of inspection and answering post-inspection CAPA

Inpharmatis is ready to become your reliable partner in the field of post-marketing surveillance of medicines, ensuring the safety and efficacy of your products in the EAEU markets.

For more information, please contact us: info@inpharmatis.com.