1. No person may open Bioequivalence Centre 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 Bioequivalence Centre: a. Obtain a valid Good Clinical Practice and/or Good Laboratory 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 Bioequivalence studies. c. The presence of a qualified and specialized cadre in the field of Bioequivalence studies and 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 Bioequivalence studies and research outcomes. e. Having an appropriate system in place to track and manage 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 study and research. g. Providing the necessary infrastructure and Establishments at the study and research site to ensure the safety of participants. h. Fulfilling the other conditions for the license, including the conditions for accrediting the research or study site 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 Bioequivalence Centre 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 Bioequivalence Centre shall be issued in accordance with the commercial license issued by that authority. 4. Bioequivalence Centre operating in free zones are exempted from the percentage referred to in Clause (3) of this Article, as are any other General Pharmacies specified by a resolution issued by the Cabinet. 5. The Owner of Bioequivalence Centre shall appoint citizens in the professions required by the activity of this center 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 Bioequivalence Centre within their jurisdiction. 7. If the Bioequivalence Centre 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 laboratory 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 Bioequivalence Centre and any other information related to Biobanks, in accordance with the mechanism agreed upon in accordance with Article (174) of this Decree-Law. 9. Bioequivalence Centre 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.