PRESIDENT

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