إجراء مقترح من أوكرانيا: المنتجات الصيدلانية

The Order of the Ministry of Health of Ukraine No. 740 of 3 June 2026 approves a new Procedure for Pharmacovigilance, developed pursuant to the Law of Ukraine No. 2469-IX of 28 July 2022 'On Medicinal Products' and taking into account recommendations for international harmonisation in the field of pharmacovigilance. The Procedure establishes: unified approaches to the establishment and maintenance of pharmacovigilance systems at the state level and by marketing authorisation holders; requirements for the Pharmacovigilance System Master File (PSMF), which is maintained by the marketing authorisation holder; minimum requirements for the pharmacovigilance quality system for the state control authority and applicants; the use of harmonised international terminology, formats and standards in accordance with European practice; updated requirements for the collection, analysis and monitoring of data on adverse reactions, including through the national pharmacovigilance database; procedures for the electronic submission of reports on adverse reactions, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs); requirements for post-authorisation safety studies, including the form and content of study protocols and final reports. The Order also declares invalid the Order of the Ministry of Health of Ukraine No. 898 of 27 December 2006 'On Approval of the Procedure for Pharmacovigilance'.