1. No person may open Non-Clinical and Clinical Research Entity unless he has obtained a license from the EDE 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 a Clinical Research Entity: a. Obtain a valid Good Clinical Practice Certificate from the EDE. b. The existence of a quality management system that is consistent with licensed activities and good clinical practice guidelines, and the existence of a documented system of written standard operating procedures that define the processes and responsibilities for conducting Clinical Research. c. The presence of a qualified and specialized cadre in the field of Clinical Research in accordance with the applicable legislation in this regard. d. There is an appropriate system in place to protect and ensure the confidentiality of data, including personal data of research participants and Clinical Research outcomes. e. Having an appropriate system in place to track and manage biological samples and to maintain and document records. f. Having a system in place to report adverse events and reactions that could affect the health and safety of participants in Clinical Research. g. Providing the necessary infrastructure and Establishments at the Clinical Research site to ensure the safety of participants. h. Fulfilling the other conditions for the license, including the conditions for accrediting the clinical research site, which are specified in the Executive Regulations of this Decree-Law 3. The following conditions shall be met to obtain a license to open a Non-Clinical Research Entity: a. Compliance of the non-Clinical Research entity with relevant good practice principles and codes issued or approved by the EDE. b. The existence of a quality management system that is consistent with licensed activities and good clinical practice guidelines, and the existence of a documented system of written standard operating procedures that define the processes and responsibilities for conducting Clinical and non-clinical Research. c. The presence of a qualified and specialized cadre in the field of Clinical Research in accordance with the applicable legislation in this regard. d. Having an appropriate system to protect and ensure the confidentiality of data and research outputs. e. Having an appropriate system in place to track and manage biological samples and to maintain and document records. f. Fulfilling the other conditions for the license specified by the executive regulations of this Decree-Law. 4. 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 Clinical and non-clinical Research 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 Clinical and non-clinical Research shall be issued in accordance with the commercial license issued by that authority. 5. Clinical and Non-Clinical Research Entity operating in free zones are exempted from the percentage referred to in Clause (4) of this Article, as are any other Clinical and Non-Clinical Research Entity specified by a resolution issued by the Cabinet. 6. The Owner of Clinical and Non-Clinical Research Entity shall appoint citizens in the professions required by the activity of this pharmacy in accordance with the percentages specified in the legislation in force in this regard. 7. The Competent Health Authority may add any technical and health conditions and other controls for licensing Clinical and Non-Clinical Research Entity within their jurisdiction. 8. If the Clinical and Non-Clinical Research Entity 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 entity to perform its licensed activity and not for the purposes of trade and circulation. 9. The Competent Health Authority shall inform the EDE of the Licenses issued by it to Clinical and Non-Clinical Research Entity and any other information related to Clinical and Non-Clinical Research Entity, in accordance with the mechanism agreed upon in accordance with Article (174) of this Decree-Law. 10. Clinical and Non-Clinical Research Entity 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.
Interpretation and application must be checked against the official text and current version.