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Hi Everyone, Our company is in the process of migration from paper-based to electronic quality document management system. Technically the transition is done by the respective scanned copies (that contain manual signatures) upload on system in the 'draft' state with subsequent approval of the imported ...

Dear Jo, For pharmaceutical product if no other parts of the dossier apart from the MAH name is changing then this is considered as administrative variation which takes 30 days for approval by RU MOH (respective PoA from the manufacturer to the new MOH is required in this case). You will also need ...

Hi, According to the requirements to MDs labeling established for Russian market (see Decision of Eurasian Economic Union #27 "On approval of general requirements to safety and efficacy of medical devices, requirements to their labeling and maintenance documentation" dd. Feb 12th 2016), each medical ...