Omnigen’s team, faithful to the vision for continuous improvement of our services and with respect to the parents, successfully completed all procedures and prerequisites for licensing of the company by the Greek ministry of health. Omnigen is the first company in Greece receiving the legal opinion from the National Transplant Organization (NTO – Doc. Ref. 5781 / 17-12-2015) in accordance with the applicable law 3984/2011 and the Directive of the European Union 2006 / 17 / EC to operate as stem cells bank both for cord blood and cord tissue stem cells for transplants intended for human application.
According to the Greek legislation (OGG51/2008) from 24 March 2008 and (OGG150/2011) from 26 June 2011 and implementing the 2004/23 / EK European Directive, the cord blood cryopreservation banks must be audited according the procedures and the norms of GMP (Good Manufacturing Practice). Omnigen following the above, abides to all procedures dictated from the above legislation for the operation of cord blood cryopreservation banks.
Omnigen in accordance with the above standards of certification and accreditation, is subject to audit procedures at regular intervals. As a result all our services are governed by strict criteria and high quality standards. The Control System and Quality Management currently installed, fully abides to standards set by the International Organizations FACT (Foundation for the Accreditation of Cellular Therapy), the European transplant units Inspection Agency JACIE (Joint Accreditation Committee ISCT-EBMT) the European Directives and the Greek Legislation (OGG 51A, 24/03/2008) establishing quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells). The Quality Control System ensures the safe and smooth operation of laboratories and the company in general.
In addition, Hellenic Cord Blood Banks Union – EETOA will potentially function as an independent body which, among others, will supervise its members, so that all member companies will operate under the strict standards dictated by the European directives and Greek legislation.