Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 119 — Article (119) License Conditions

Part Seven: Licence of Pharmaceutical Establishments and Biobanks · Chapter Six: Pharmaceutical Products

1. No person may open a Pharmaceutical Laboratory unless he has obtained a license from the EDE. 2. The following conditions shall be met to obtain a license to open a Pharmaceutical Laboratory: a. Obtain a valid Good Laboratory Practice Certificate from the EDE. b. To entrust its technical management to a licensed person who is responsible and dedicated to working in it. c. The Pharmaceutical Laboratory shall comply with safety requirements and have preventive measures in place to ensure that no pollutants leak into the environment. 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 Pharmaceutical Laboratory 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 Pharmaceutical Laboratory shall be issued in accordance with the commercial license issued by that authority. 4. Pharmaceutical Laboratory operating in free zones are exempted from the percentage referred to in Clause (3) of this Article, as are any other Pharmaceutical Laboratory specified by a resolution issued by the Cabinet. 5. The Owner of a Pharmaceutical Laboratory shall appoint citizens in the professions required by the activity of this laboratory in accordance with the percentages specified in the legislation in force in this regard. 6. The Executive Regulations of this Decree-Law shall specify the controls and conditions for accrediting pharmaceutical laboratories outside the State mentioned in Article (26) of this Decree-Law and the certificates issued by them. 7. The EDE shall inform the Competent Health Authority of the licenses issued by it to Pharmaceutical Laboratory and any other information related to Pharmaceutical Laboratory, in accordance with the mechanism that is agreed upon in accordance with Article (174) of this Decree-Law.

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