Pharmacovigilance services in Ukraine

The pharmacovigilance procedure in Ukraine is regulated by the Order of the Ministry of Health of Ukraine No. 898 dated December 27, 2006, "Procedure for Conducting Pharmacovigilance" developed based on the international standards of EU Directive 2001/83 and EU Council Regulation 726/2004.

Pharmacovigilance is a crucial part of the process for monitoring the safety of medicinal products during their lifecycle.

We are pleased to offer the following pharmacovigilance services in Ukraine, including CPPV appointment, GVP compliance, safety monitoring, and regulatory support for medicinal products:

Appointment of a local contact person of qualified person responsible for pharmacovigilance (CPPV) in Ukraine

Establishment of a quality management system in accordance with Good Pharmacovigilance Practice (GVP) requirements for CPPV responsibilities;
Collection and submission of adverse reaction and/or lack of efficacy reports within Ukraine;
Regular monitoring of regulatory updates and local scientific literature;
Submission of all necessary documents related to the Pharmacovigilance system and interaction with regulatory Authority on behalf of the marketing authorization holder (MAH);
Assisting in the preparation of responses to inquiries from the Authority;
Support during audits conducted by the Authority to verify compliance with GVP requirements;

Comprehensive support in other pharmacovigilance services

Development and maintenance of all required documentation: Pharmacovigilance System Master File (PSMF), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR), etc.;
Providing consulting support regarding all aspects of creating and operating pharmacovigilance systems.

To get more detailed information, including pricing for our pharmacovigilance services, please contact our specialists.