Dear applicants!

The State Expert Center of the Ministry of Health of Ukraine informs that the Pharmacovigilance Department continues its work under martial law and during the period of martial law in the following areas:

• we receive and approve letters of appeal for healthcare professionals and other communication materials for subsequent posting on the Center's website (materials with a cover letter should be sent to the e-mail addresses dec@dec.gov.ua and bashkatova@dec.gov.ua);
• we process letters regarding the removal of outdated versions of communication materials from the official website of the Center, or following the approval of new versions of communication materials (materials with a cover letter should be sent to the e-mail addresses dec@dec.gov.ua and bashkatova@dec.gov.ua);
• we monitor the websites of stringent regulatory authorities for new safety information, followed by publication on the Center’s official website in the “Pharmacovigilance” section;
• we approve draft protocols of post-registration non-interventional safety and efficacy studies of medicinal products initiated and managed by the applicant in accordance with obligations (send materials with a cover letter to the e-mail addresses dec@dec.gov.ua and bashkatova@dec.gov.ua);
• we provide consultations to applicants on the expert evaluation of pharmacovigilance materials by e-mail bashkatova@dec.gov.ua or via visualization;
• we continue working on processing materials concerning the conducted audits of applicants' pharmacovigilance systems, including preparing the report on the results of the audit of the applicant's pharmacovigilance system and processing the Corrective and Preventive Action Plans submitted by the applicant;
• we are receiving and analyzing periodic safety update reports (PSURs). For the period of martial law in Ukraine, please submit PSURs in electronic format with a cover letter to PSUR@dec.gov.ua, dec@dec.gov.ua and bashkatova@dec.gov.ua;
• we provide consultations on the operation of the Information Resource "List of terms and frequency of submission of periodic safety update reports for medicinal products, vaccines, and tuberculin by international nonproprietary name of the active pharmaceutical ingredient or combinations of active pharmaceutical ingredients" in electronic format (send requests to the e-mail address bashkatova@dec.gov.ua and PSUR@dec.gov.ua);
• we continue to receive reports of adverse reactions and/or lack of efficacy with the use of medicinal products, vaccines and tuberculin from applicants at the e-mail address cioms@dec.gov.ua or through the “Applicant's Electronic Account of the AISF”;
• we process and respond to applicants' letters requesting information on adverse reaction/lack of efficacy cases registered with the use of medicinal products in Ukraine. Letters should be sent to the e-mail addresses dec@dec.gov.ua and bashkatova@dec.gov.ua;
• questions regarding the operation of the AISF applicant's electronic account and the provision/extension of paid access to the AISF database (send requests to the e-mail dec@dec.gov.ua, aisf@dec.gov.ua and bashkatova@dec.gov.ua.

We also provide consultations on any issues within the competence of the pharmacovigilance department by e-mail bashkatova@dec.gov.ua or via visualization.

We hold on and keep working!

Everything will be Ukraine!