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� �� . �� 1975, �� -�� , �� (EE), �� 75/319/EEC, �� , �� 29�, �� . �� (surveillance) �� , �� , � �� , �� . �� , �� 1989, � �� 89/381/EEC �� , �� , �� , �� , �� . �� .⁶

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* �� ��  (blood products) �� ��  (blood components), �� , �� , �� , �� , �� ��  � �� (blood � plasma derivatives), �� , �� , �� .�. � �� : �� , �� . �� (drugs � pharmaceutical products), �� (medicinal products) �� (�� ) �� . �� .

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�� . ��-��-�� (1996�1997). �� , ��, 1999
LAWSON DH. Pharmacovigilance in the 1990�s. Br J Clin Pharmacol 1997, 44:109�110
MEYBOOM RH, EGBERTS AC, EDWARDS IR, HEKSTER YA, DE KONING FH, GRIBNAU FW. Principles of signal detection in pharmacovigilance. Drug Safety 1997, 16:355�365
WALLER PC. Pharmacovigilance: towards the next millenium (editorial). Br J Clin Pharmacol 1998, 45:417
TALBOT JC, NILSSON BS. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol 1998, 45:427�431
CEC. Blood safety and self-sufficiency: an agenda for the European Community. County Limerick, Ireland, 1996
MEYBOOM RH, HEKSTER YA, EGBERTS AC, GRIBNAU FW, EDWARDS IR. Causal or causal? The role of causality assessment in pharmacovigilance. Drug Safety 1997, 17:374�389
McCLELLAND B, LOVE E, SCOTT S, WILLIAMSON LM. Haemovigilance: concept, Europe and UK initiates. Vox Sang 1998, 74(Suppl 2):431�439
NOEL L, DEBEIR J, COSSON A. The French haemovigilance system. Vox Sang 1998, 74(Suppl 2):441�445
ROUGER P, HERSON E. Contribution of hemovigilance to immunologic safety of blood transfusions: assessment after 3 years. Transfus Clin Biol 1998, 5:219�224
SAZAMA K. Adverse effects of blood transfusion. In: Rakel RE (ed) Conn�s Current Therapy. WB Saunders Co, London, 1999:451�455
PEREZ P, NGOMBET R, DEBEIR J, NOEL L, SARI F. Transfusion incidents related to bacterial contamination: review of the literature and haemovigilance. For the working group bacterial incidents of blood agency, scientific advice of Bacthem and the French hemovigilance network. Transfus Clin Biol 1998, 5:203�210
VAN AKEN WG, VAN ROOD JJ. Safety of blood transfusions. Need for hemovigilance. Ned Tijdschr Geneeskd 1998, 142:281�284
QUARANTA JF, CANIVET N. What is the use of hemovigilance. Transfus Clin Biol 1998, 5:415�421
INGRAND P, SALMI LR, BENZ-LEMOINE E, DUPUIS M. Evaluation of the actual traceability of labile blood products using medical records. Transfus Clin Biol 1998, 5:397�407
OLSSON S. The role of WHO programme on international drug monitoring in coordinating worldwise drug safety effords. Drug Safety 1998, 19:1�10

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