Dossiers for Human Tissue Grafts for Licensing by the National Transplant Organization (EOM)

It concerns Tissue Establishments and Tissue Importing Establishments that operate, or wish to operate, at National and European level.

Under Presidential Decree 26/2008, as amended by Presidential Decree 129/2016 and Law 3984/2011, these organizations must submit to the Greek Competent Authorities (Ministry of Health and National Transplant Organization – EOM) a complete dossier in order to obtain the relevant licence, depending on their activity.

What can the NOVITAS can do for you:

• Preparation of a complete licensing dossier.
• Communication with the organizations involved (National Transplant Organization – EOM & Ministry of Health – Directorate for the Development of Health Units).
• Development and installation of the appropriate quality system required to support the activities of Tissue Establishments and Tissue Importing Establishments.
• Second-party audits of Third-Country Tissue Establishments in accordance with the provisions of Presidential Decree 129/2016
• Certification services.
• Development of appropriate process protocols, from the collection through to the delivery of tissue grafts to the application unit.