The 1st Stem Cells Bank in Greece licensed by the Ministry of Health!
OMNIGEN SA has completed all the necessary procedures and becomes the first umbilical cord blood bank in Greece licensed by the Ministry of Health with the decision No. Γ2γ/31238 (OGG B’2339/15.06.2020).
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.