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According to the «Agreement on Common Principles and Rules for the Circulation of Medicinal Products» within the Eurasian Economic Union dated December 20, 2014 marketing authorization holder (MAH) must ensure the effective functioning of the separate EAEU Pharmacovigilance system in accordance with Good Pharmacovigilance Practice (GVP) covering the territories of the Member States.
The pharmacovigilance system is designed to ensure the safety of medicinal products. It allows for timely monitoring of all changes in the assessment of the benefit-risk ratio and the implementation of necessary measures for the safe use of medicinal products.
As part of providing and maintenance of the EAEU Pharmacovigilance system, Mikhailyuk, Sorokolat and Partners provides the following services:
- Establishment of a quality management system in accordance with the EAEU GVP requirements;
- Appointment of a Qualified Person responsible for Pharmacovigilance (QPPV);
- Development and maintenance of all required documentation (Pharmacovigilance System Master File (PSMF), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR), Instructions for medical use (IFU)/ Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC), etc.);
- Collection and submission of adverse reaction and/or lack of efficacy reports within the EAEU territory;
- Regular monitoring of scientific literature and regulatory updates;
- Interaction with regulatory authorities on behalf of the MAH;
- Comprehensive consulting support.
For more detailed information, including the cost of establishing a Pharmacovigilance system in the EAEU territory, please contact our specialists.
