Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 134 — Article (134) License Conditions

Part Seven: Licence of Pharmaceutical Establishments and Biobanks · Chapter Eight: Licensing Contractual Companies for Research and Development

1. No person may open a Licensing Contractual Company for Research and Development 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 a Contractual Company for Research and Development: a. The License Applicant or his legal representative shall be the Owner of the Contractual Company for Research and Development and be legally responsible for complying with the legislation and instructions issued by the EDE concerning the Contractual Company for Research and Development. b. Obtain a valid Good Clinical Practice Certificate from the EDE. 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 Contractual Company for Research and Development 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 Contractual Company for Research and Development shall be issued in accordance with the commercial license issued by that authority. 4. Contractual Company for Research and Development operating in free zones are exempted from the percentage referred to in Clause (3) of this Article, as are any other Contractual Company for Research and Development specified by a resolution issued by the Cabinet. 5. The Owner of Contractual Company for Research and Development 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. 6. The Competent Health Authority may add any technical and health conditions and other controls for licensing Contractual Company for Research and Development within their jurisdiction. 7. The Competent Health Authority shall inform the EDE of the Licenses issued by it to Contractual Company for Research and Development and any other information related to Contractual Company for Research and Development, in accordance with the mechanism agreed upon in accordance with Article (174) of this Decree-Law. 8. In the event that the Contractual Company for Research and Development wishes to import pharmaceutical raw materials and Medical Products or export Medical Products in their final form to the Entity contracting with the Establishment, it shall obtain permit 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 company to perform its licensed activity. 9. Contractual Company for Research and Development 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.

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