1. No person may open a Medical Product Factories and Contracting Companies Manufacture Medical Products unless he has obtained a license from the EDE. 2. The following conditions shall be met to obtain a license to open a Medical Product Factories and Contracting Companies Manufacture Medical Products: a. Obtain a valid Good Manufacturing Practice Certificate from the EDE. b. The License Applicant or his legal representative shall be the Owner of the factory and be legally responsible for complying with the legislation and instructions issued by the EDE concerning the factory or contracting company for the manufacture of Medical Products. c. In the event of engaging in the activity of importing, exporting, marketing or distributing Medical Products in the State, a license shall be obtained from the EDE. d. 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 Medical Product Factories and Contracting Companies Manufacture Medical Products 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 Medical Product Factories and Contracting Companies Manufacture Medical Products shall be issued in accordance with the commercial license issued by that authority. 4. Medical Product Factories and Contracting Companies Manufacture Medical Products operating in free zones are exempted from the percentage referred to in Clause (3) of this Article, as are any other Medical Product Factories and Contracting Companies Manufacture Medical Products specified by a resolution issued by the Cabinet. 5. The Owner of Medical Product Factories and Contracting Companies Manufacture Medical Products shall appoint citizens in the professions required by the activity of this factory or company in accordance with the percentages specified in the legislation in force in this regard. 6. The EDE shall inform the Competent Health Authority of the Licenses issued by it to Medical Product Factories and Contracting Companies Manufacture Medical Products and any other information related to Medical Product Factories and Contracting Companies Manufacture Medical Products, in accordance with the mechanism agreed upon in accordance with Article (174) of this Decree-Law.
Interpretation and application must be checked against the official text and current version.