1. No person may open a Biobank unless he has obtained a license from the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. 2. The following conditions shall be met to obtain a license to open Biobank: a. The existence of a quality management system that is compatible with the licensed activities. b. The existence of an appropriate system for tracking biological samples, and the existence of a system for reporting, investigating, recording, and transmitting information about the occurrence of any serious complications or adverse reactions that may affect the quality and safety of these samples. c. Fulfilling the technical and health requirements and other requirements specified by the Executive Regulations of this Decree-Law. 3. Subject to the provisions of the Commercial Companies Law, the Local Authority responsible for corporate affairs in the relevant emirate shall have the EDE to determine a specific percentage of citizens’ contribution to the capital of a company that carries out the activity of Biobank or to open the way for full foreign Ownership, while determining the percentage of citizens’ participation in the BOD of companies established within their jurisdiction. The License to open a Biobank shall be issued in accordance with the commercial license issued by that authority. 4. Biobank operating in free zones are exempted from the percentage referred to in Clause (3) of this Article, as are any other Biobank specified by a resolution issued by the Cabinet. 5. The Owner of Biobank shall appoint citizens in the professions required by the activity of this bank in accordance with the percentages specified in the legislation in force in this regard. 6. The Competent Health Authority may add any technical and health conditions and other controls for licensing Biobank within their jurisdiction. 7. If the Biobank wishes to import Medical Products, it shall obtain approval from the EDE in accordance with the provisions of Article (32) of this Decree-Law, provided that the purpose of the import is for the Biobank to perform its licensed activity and not for the purposes of trade and circulation. 8. The Competent Health Authority shall inform the EDE of the Licenses issued by it to Biobanks and any other information related to Biobanks, in accordance with the mechanism agreed upon in accordance with Article (174) of this Decree-Law. 9. Biobank may provide their services electronically in accordance with a system issued by a decision of the Chairman or his delegate or the head of the Competent Health Authority, each within the limits of their jurisdiction. 10. The Cabinet shall issue a decision based on a proposal from the President, in coordination with the Competent Health Authorities, to regulate the work of Biobanks in accordance with their activity. 11. The regulatory and operational standards for the blood transfusion system in the State shall be issued by a resolution of the Cabinet based on the proposal of the President.
Interpretation and application must be checked against the official text and current version.