In the first quarter of 2025, the SEC will conduct targeted audits of the pharmacovigilance systems of 4 applicants (registration certificate holders for medicinal products). The audit schedule can be viewed at the link http://surl.li/exojlc
The aim is to verify applicants’ compliance with statutory requirements in carrying out certain pharmacovigilance processes.
Based on the audit results, reports will be prepared indicating the nonconformities identified (if any). In accordance with the legislation, if critical and/or major nonconformities are identified, applicants must prepare and send to the Center information on the timelines for corrective and preventive actions to eliminate them.
If the critical non-conformities identified are not eliminated within the specified period, the State Expert Center will submit to the Ministry of Health of Ukraine proposals for a temporary ban on the use of the medicinal product(s) by suspending the registration certificate(s).
Please note that the specialists of the Pharmacovigilance System Audit Department of the Center are always ready to provide consultations or answers to any questions from applicants concerning the conduct of audits. Questions can be sent to the e-mail address gpvp-audit@dec.gov.ua.
Answers to the most frequently asked questions can be found on the Center's website at http://surl.li/lzkpxa
We remind you that, in accordance with legislation, targeted audits of applicants' pharmacovigilance systems are conducted for the following reasons:
- not related to issues concerning the safety of medicinal products, vaccines, tuberculin, or to reasons of non-compliance with established requirements (changes in the organizational and legal form of enterprises, a significant change to the enterprise’s own pharmacovigilance system, etc.);
- relating to issues related to the safety of a medicinal product, vaccine, tuberculin, or for reasons of non-compliance with established requirements (untimely submission of reports on adverse reactions of a medicinal product, vaccine, tuberculin and/or lack of efficacy of a medicinal product, submission of incomplete reports; submission of clinical overview addenda of inadequate quality; submission of periodic safety reports of inadequate quality; submission of risk management plans of inadequate quality; discrepancy between data stated in reports and data from other information sources; changes in the benefit/risk balance; results of previous audits; publication of pharmacovigilance information that is biased or misleads the public, etc.).
