During the second quarter of 2024, the State Expert Center of the Ministry of Health of Ukraine (the Center) will conduct a targeted audit of the pharmacovigilance systems of three applicants (holders of registration certificates for medicinal products in circulation in Ukraine).
According to the Audit Division of the State Expert Center of the Ministry of Health of Ukraine, the inspections will take place within the schedule of targeted audits of applicants' pharmacovigilance systems for the first half of 2024: http://surl.li/ryizs
In accordance with the clarification of the Audit Directorate, a targeted audit of the applicant's pharmacovigilance system may be conducted for reasons specified in subparagraph 2 of paragraph 2 of Chapter 2 of Section VII of the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine of 27 December 2006 No. 898 (as amended by order of the Ministry of Health of Ukraine of 26 September 2016 No. 996). These reasons can also be viewed on the Center's website at: http://surl.li/ryiym
Following the audit, a report is drawn up which, if necessary, will specify the identified non-conformities. To eliminate the identified critical and major non-conformities, the applicant must develop corrective and preventive actions.
In total, for the first half of 2024, the State Expert Center of the Ministry of Health of Ukraine (the Center) has planned five targeted audits of applicants’ pharmacovigilance systems. As of March 2024, two audits had been conducted by the Center.
During the audits already conducted, appropriate measures were taken so that the audits were carried out in a combined format, that is, directly at the location of the applicant/applicant's representative and remotely using computer programs for online communication.
Reminder: Applicants are obliged to establish, maintain, and guarantee the functioning of their own pharmacovigilance system, which is a mandatory condition for the circulation of medicinal products, vaccines, and tuberculin. These requirements are set out in Section V of the Procedure for Pharmacovigilance.
The Division of Audit of the Applicants' Pharmacovigilance System regularly publishes information on audit results on the official website of the Center at http://surl.li/ryjbh
Information on the results for 2023 will be published soon.
If you have questions about the audit of the pharmacovigilance system, you can contact the Division for Audit of the Applicants' Pharmacovigilance System by sending your questions to the e-mail: gpvp-audit@dec.gov.ua.
More detailed information can be viewed on the website of the Center at the link https://www.dec.gov.ua/…/audit_pharmacovigilance_system/
