PRESIDENT ADMINISTRATIVE COUNCIL SCIENTIFIC COUNCIL COUNSELLOR ON MEDICAL ISSUES – EFFICACY AND SAFETY COUNSELLOR ON PHARMACEUTICAL ISSUES QUALITY ASSURANCE BUREAU (QAB) INTERNAL AUDIT BUREAU (IAB) LEGAL DEPARTMENT Prevention and Protection Service for Safety and Health at Work POLICIES AND STRATEGIES DEPARTMENT European Affairs Service Administrative legal service, European legislation and National legislation VICEPRESIDENT Parallel import bureau National procedures admin. service National Procedures Department National procedures evaluation service Med. prod. and active subs. quality bureau Efficacy bureau Med. inf. bureau Clinical studies service European proc. admin. service European procedures variations service Pharmacovigilance and risk management service European Procedures Department Efficacy bureau European procedures evaluation service Med. inf. bureau Non-clinical safety bureau Physico-chemical analysis laboratory – pharmaceutical forms Instrumental analysis laboratory Pharmacology- toxicology laboratory Microbiology laboratory Radiopharmaceutical products control laboratory Medicinal Prod. Quality Control Department Biological Prod. Evaluation and Control Dep. Cell culture laboratory measurements and specific microbiology Laboratory for determinations by serological tests Laboratory for physical- chemical and immunological determinations PID processes management service GMP, GLP, GALP, GCP and Pharmacovigilance inspection service Medicinal products quality surveillance service and rapid alerts Good Distribution Practice inspection service Pharmaceutical Inspection Department TIU – Iasi, Timisoara, Galati, Oradea TIU – Deva, Tg. Mures, Constanta, Bacau TIU – Cluj, Pitesti, Satu Mare, Craiova Technical Laboratory Department Certification Department Medical Devices control service by periodic verification Medical Devices testing department Medical Devices certification service and management system Technical-Medical units assessment service Economic Department Budget service General Administration Department Public acquisitions service Transport unit Metrology unit Goods management service Administrative service, maintenance, repair, security and fire NUCLEAR UNIT Information Logistics and Electronic Management of Data Department Information and logistics service Inter/intra- departmental communications office Registry – document distribution and release Data and document management service Archive service Human Resources and Payroll Department Office staff, monitoring statements of interest, payroll Logistics Human Resources Office Organisational Chart NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES Non-clinical safety bureau National procedures variations service Administrative verification and prod. index bureau Financial service - Accounting Validation bureau Centralised procedures administration office Communication, institutional relations and pharmacopoeia services Ilfoveni Farm Medicinal prod. and active subs. quality bureau Domnesti Farm Civil Protection Department