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Edelgard Rehak, Ph.D.
MerkenRemote GMP inspections by Russian authorities
Rubrik: Ausland
(Treffer aus pharmind, Nr. 07, Seite 943 (2021))
Remote GMP inspections by Russian authorities / Experiences and guidance · Rehak, Ph.D. E1, Kobro (M.A.) M2 · 1Edelgard Rehak Consulting, Berlin und GMP language support, Munich
GMP inspections of production facilities of foreign manufacturers by Russian authorities were introduced in 2016 by Federal Law N 61-FZ dated 12.04.2010 (as amended) [ 1 ]. A valid GMP certificate is a prerequisite for new registrations of medicinal products as well as for the maintenance of existing registrations (renewals, variations) in Russian Federation. Without GMP certification of the manufacturing site, the regular import of medicinal products into the Russian Federation is not permitted. Due to the COVID-19 pandemic and the travel ban on Russian inspectors, the continuation of GMP inspections was endangered, as on-site visits to the manufacturing sites ...
