Review of the Certification Procedure for Qualified Persons of Manufacturers of Medicines for Human Use in Russia

In December 2020, the Russian Federation adopted Eurasian Economic Union (EAEU) requirements. This has significantly changed certification procedure for qualified persons (QPs) of manufacturers medicinal products human use in Federation. To accommodate these changes, regulatory framework needs further improvement. The aim study was to review changes made mechanism state regulation medicines and evaluate impact on pharmaceutical industry two years after adoption current QP procedure. compares procedures established by Order No. 7n Ministry Health dated 12 January 2021. first is an abbreviated one QPs certified under previous procedure, second initial being time, having expired certificate, or wishing extend their professional qualification profiles. article illustrates common mistakes applicants when preparing documents. Furthermore, authors describe most prevalent knowledge gaps identified testing. ensured a sufficiently smooth transition EAEU For example, 1 February 2023, 506 were recertified next five-year period according this accounts slightly more than half all total number requirements Russia 2021–2022 approximately 1.5 times higher during same 2014–2015. updated noticeably occupational group formed last decade. implementation new revealed several procedural issues that require additional explanation clarification