UAE Healthcare / Pharma LawCabinet Resolution No. (16) of 2026 Regarding the Executive Regulations of Federal Decree by Law No. (25) of 2023 Regarding the Donation and Transplantation of Organs and Tissues

Article (1) Definitions The definitions set forth in the aforementioned Federal Decree by Law No. (25) of 2023 shall apply to this Resolution. Save as otherwise provided therein, the following terms and expressions shall have the meanings assigned to each of them, unless the context requires otherwise: Health Establishments : Entities licensed to perform the Removal or Transplantation of Organs, parts thereof, and Tissues. Consent : The expression of Willingness by a living person, or by the relatives of a deceased person, to donate the deceased person's Organs and Tissues, through a free and informed Will, in accordance with the provisions of the Decree by Law and this Resolution. Decree by Law : Federal Decree by Law No. (25) of 2023 Regarding the Donation and Transplantation of Human Organs and Tissues, as amended.

Article (2) Controls Governing the Licensing of Health Establishments for the Removal and Transplantation of Organs, Parts Thereof, and Tissues 1. The Ministry or the Health Authority shall verify that a Health Establishment satisfies the following controls before licensing it to perform procedures for the Removal and Transplantation of human Organs, parts thereof, and Tissues: a. The Health Establishment shall possess the equipment, medical supplies, and infrastructure necessary for carrying out Removal procedures, Transplantation procedures, or both, in accordance with the requirements prescribed by a decision of the Minister and the Procedures Manual for the Donation and Transplantation of Human Organs, Parts Thereof, and Tissues issued by the National Center in coordination with the Health Authorities. b. Availability of specialized professional personnel responsible for introducing and raising awareness regarding the Organ Donation program and the Removal and

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 3 Transplantation of human Organs, parts thereof, and Tissues, and for facilitating Donation-related procedures in a manner that enables members of society to exercise their right to donate and promotes awareness thereof. c. Availability of specialized professional personnel qualified to perform the Removal and Transplantation of human Organs, parts thereof, and Tissues. d. The Health Establishment shall maintain a laboratory accredited in accordance with the standards adopted by the Ministry or the Health Authority. e. The Health Establishment shall adopt a plan ensuring the safety of medical equipment and devices in accordance with the standards approved by the Ministry or the Health Authority. f. Any other controls prescribed by a decision issued by the Minister based on a submission by the National Center following coordination with the Health Authorities. 2. The Ministry or the Health Authority shall determine the validity period of the license, provided that it shall not be less than one (1) year and not exceeding three (3) years.

Article (3) Controls Governing Renewal of the Health Establishment License 1. A Health Establishment may apply for renewal of its license to perform Removal and Transplantation of human Organs, parts thereof, and Tissues within thirty (30) days from the date of expiry of the license, using the prescribed form and attaching the following: a. A report containing the following data: 1. Number of living donors of Organs, Tissues, or both. 2. Number of posthumous donors of Organs or Tissues. 3. Number and type of donated Organs. 4. Number of Transplantation procedures performed during the reporting period. 5. Number of patients who underwent Organ or Tissue Transplantation procedures. 6. Success rate of Removal procedures, Transplantation procedures, or both. 7. Extent of the Health Establishment's monitoring of donors and recipients.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 4 8. Number of cases in which complications arose from Removal or Transplantation procedures and the measures taken by the Health Establishment in each case, or which resulted in documented medical errors. 9. Number of Deaths occurring following Removal procedures or Transplantation procedures. b. Successful completion by the Health Establishment of the audit procedures conducted by the National Center or the Health Authority. 2. Any other requirements prescribed by a decision issued by the Minister based on a submission by the National Center following coordination with the Health Authorities.

Article (4) Controls Governing the Licensing of Specialist Physicians 1. To obtain a license to perform Removal and Transplantation of human Organs and Tissues, a physician shall satisfy the following controls: a. The physician shall hold a license to practice the profession in the relevant specialty, qualifying them to practice in the field of Organ Transplantation within the same specialty, in accordance with the Unified Healthcare Professional Qualification Requirements (PQR) adopted pursuant to the aforementioned Cabinet Resolution No. (20) of 2017. b. The physician shall have successfully completed accredited training in the field of Removal and Transplantation of human Organs and Tissues, have practical experience in the same field, or hold a professional qualification from an accredited educational institution, in accordance with the Unified Healthcare Professional Qualification Requirements, based on a proposal of the National Center and in coordination with the Health Authorities. c. The physician shall obtain the approval of the National Center to perform Organ and Tissue Removal and Transplantation procedures. d. Any other requirements prescribed by a decision issued by the Minister based on a submission by the National Center following coordination with the Health Authorities.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 5 2. The duration of the physician's license and the renewal thereof shall be determined by the Health Authority, provided that each duration shall not be less than one (1) year and not exceeding three (3) years, upon the physician's application.

Article (5) Expression of Willingness or Will to Donate Human Organs and Tissues 1. The National Center shall establish one or more systems for recording a Person's willingness to donate human Organs and Tissues during their lifetime or to make a Will for such Donation after Death, as well as recording their unwillingness to donate after Death. The system shall permit withdrawal of the wish to donate or not to donate at any time. In all cases, the expression of the willingness or unwillingness to donate shall be made in writing and duly authenticated in accordance with the following controls: a. Adoption of an electronic form for expressing the willingness or unwillingness to donate. b. Authentication of the Person's expression of willingness through access to the digital identity system in force within the State. c. Compliance with the controls and procedures prescribed by the National Center concerning the expression of willingness, unwillingness, or the withdrawal of either. 2. The system referred to in Clause (1) of this Article shall provide for the following: a. The recording and authentication of a Person's expression of willingness or unwillingness to donate, or their Will to donate in an official manner. b. Ensuring the validity and reliability of registration and verifying that it is based on free will, by linking the system with the Person's electronic medical record. c. Flexible registration procedures and the ability to amend and update data. d. The ability to withdraw the willingness or Will to donate at any time. e. Electronic integration of the system with Health Authorities and Health Establishments within the State. f. Enabling the competent authorities within the State to access the system through approved electronic systems using multiple connectivity channels and approved digital platforms.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 6

Article (6) Controls Governing Paired Donation 1. The following conditions shall be satisfied for performing paired Donation of human Organs and Tissues: a. There shall be a patient requiring an Organ Transplantation who has a donor who is not biologically compatible with that patient. b. There shall be another patient from a different family requiring an Organ Transplantation who has a donor related thereto up to the fourth degree who is not biologically compatible with that patient. c. Each of the donors referred to in Paragraphs (a) and (b) of this Clause shall be biologically compatible with the unrelated patient from the other family. 2. Where the conditions set forth in Clause (1) of this Article are satisfied, paired Donation between the two families may be conducted in accordance with the following: a. The donors referred to in Paragraphs (a) and (b) of Clause (1) of this Article shall consent to donate to the patient of the other family on a reciprocal basis, and their intentions shall coincide with respect to completing the exchange procedure. Such consent shall be evidenced in writing and authenticated through the prescribed means of authentication. b. The Health Establishment shall provide both families with a precise explanation of the medical reasons for the absence of biological compatibility and the importance of such compatibility for the safety of the patient and the success of the surgical procedure. 3. When conducting paired Donation procedures, Health Establishments shall comply with the conditions, procedures, and standards legally prescribed for Organ Donation and Transplantation procedures, in addition to the following: a. In the case of asynchronous paired Donation, where a circumstance arises preventing the other patient from donating or where such patient refuses to complete the Donation procedures, the National Center shall include the affected patient's name on the priority list for allocation of the Organ required for Transplantation or refer the matter to the Committee referred to in Article (7) of the Decree by Law whenever the necessary conditions are satisfied.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 7 b. Where one donor withdraws from donating to the unrelated recipient after the Organ has already been retrieved from the other donor, the withdrawing donor shall bear the resulting liability in accordance with the legislation in force, unless the withdrawal was due to a reason beyond the donor's control. c. Any other requirements prescribed by the National Center following coordination with the Health Authorities.

Article (7) Controls Governing Medical Examinations and Healthcare for a Living Donor Before, During, and After Removal Without prejudice to Clause (1) of Article (9) of the Decree by Law, the Health Establishment shall conduct the necessary examinations and provide healthcare to the living donor before, during, and after Removal of a human Organ, part thereof, or Tissue, in accordance with the following controls: 1. Pre-Removal Stage a. Conducting the legally prescribed medical examinations and assessing the donor's health risks after verifying the validity of the donor's will and the absence of any factor affecting the donor's consent, including in particular: 1. Reviewing the donor's medical history, including previous surgical procedures, chronic illnesses, medications currently being taken, and family history of relevant diseases, provided that any illness suffered by the donor is adequately controlled in accordance with medical standards. 2. Updating the required vaccinations in accordance with approved medical recommendations and protocols to prevent infection before and after Removal. 3. Conducting a comprehensive clinical examination and assessing the donor's fitness and readiness for the Removal procedure. 4. Performing blood tests to verify biological compatibility in accordance with approved protocols. 5. Conducting the necessary medical imaging examinations using appropriate methods and techniques to evaluate the Organ or Tissue proposed for Donation.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 8 6. Performing any other medical examinations required by the donor's health condition. b. Providing health guidance and any necessary healthcare services to prepare the donor for the Removal procedure. c. Recording all preparatory procedures and medical follow-up measures undertaken with the donor. d. Preparing the legally prescribed medical report regarding the donor's medical suitability for the Removal procedure. e. Any other controls prescribed by the National Center following coordination with the Health Authorities. 2. During the Removal Procedure a. Taking the necessary anesthesia measures in accordance with recognized medical standards. b. Using surgical techniques that facilitate rapid recovery of the donor. c. Closely monitoring vital signs and other indicators throughout the Removal procedure to ensure donor safety. d. Applying sterilization techniques to prevent infection during the procedure. e. Communicating with the donor's family to keep them informed of the donor's condition during the procedure. 3. Post-Removal Stage a. Implementing effective pain management measures. b. Monitoring vital signs in the recovery room. c. Providing the healthcare necessary to promote recovery and prevent infection, including wound care and treatments required to prevent infections. d. Providing physiotherapy services where required by the donor's health condition. e. Establishing a dietary regimen appropriate to the donor's health condition. f. Providing psychological support as required by the donor's health condition. g. Preparing a periodic follow-up schedule in accordance with approved medical protocols to prevent complications.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 9 h. Providing health guidance and counselling to the donor regarding wound care, monitoring for signs of complications, and maintaining a healthy lifestyle following Donation. 4. Any other controls or standards established by the National Center following coordination with the Health Authorities.

Article (8) Controls Governing Healthcare for the Recipient Before, During, and After Transplantation Without prejudice to Clause (1) of Article (9) of the Decree by Law, the Health Establishment at which the Organ or Tissue Transplantation procedure is performed shall comply with the following procedures: 1. Pre-Transplantation Stage: a. Conducting the legally prescribed medical examinations of the recipient, including in particular: 1. A comprehensive review of the recipient's medical history, including previous surgical procedures, chronic illnesses, medications, and family history of relevant diseases. 2. Managing and controlling chronic diseases in accordance with medical standards to reduce risks during and after surgery. 3. Providing treatments intended to modulate the recipient's immune system cells to promote acceptance of the transplanted Organ or Tissue and reduce the likelihood of rejection. 4. Updating the required vaccinations in accordance with approved medical recommendations and protocols to prevent infection before and after Transplantation. 5. Conducting a comprehensive clinical examination and assessing the recipient's general health condition and readiness for Transplantation. 6. Performing blood tests to verify biological compatibility, including blood group compatibility, infectious disease screening, and other relevant essential factors.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 10 7. Conducting the necessary medical imaging examinations using appropriate methods and techniques to evaluate the recipient's condition. 8. Performing any other medical examinations required by the recipient's health condition. b. Providing health guidance and any healthcare services necessary to prepare the recipient for the procedure. c. Recording all preparatory procedures and medical follow-up measures undertaken with the recipient before Transplantation in the recipient's medical records. d. Preparing a medical report specifying the recipient's suitability and readiness for Transplantation. 2. During the Transplantation Procedure: a. Taking anesthesia measures in accordance with recognized medical standards. b. Using surgical techniques that ensure rapid recovery of the recipient and their return to normal life. c. Closely monitoring vital signs and other medical indicators throughout the procedure to ensure the recipient's safety. d. Applying sterilization techniques to prevent infection during the procedure. e. Assessing the function of the transplanted Organ or Tissue during surgery and taking appropriate measures in the event of any functional impairment. f. Communicating with the recipient's family to keep them informed of the recipient's condition during the procedure. 3. Post-Transplantation Stage: a. Implementing effective pain management measures. b. Monitoring vital signs in the recovery room. c. Conducting the examinations necessary to assess the function of the transplanted Organ or Tissue after Transplantation. d. Providing the care necessary to promote healing and prevent infection, including wound-care services and treatments required to prevent infections. e. Providing treatments necessary to prevent rejection of the transplanted Organ or Tissue by the recipient’s immune system.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 11 f. Providing physiotherapy services where required by the recipient's health condition. g. Establishing a dietary regimen appropriate to the recipient's health condition. h. Providing the necessary psychological support. i. Preparing a periodic follow-up schedule in accordance with approved medical protocols to prevent complications. j. Providing health guidance and counselling regarding wound care, monitoring signs of rejection or complications, and maintaining a healthy lifestyle following Transplantation. k. Providing immediate medical intervention to manage rejection episodes or health complications. 4. Any other controls or standards established by the National Center following coordination with the Health Authorities.

Article (9) Insurance Coverage for Organ or Tissue Removal and Transplantation Procedures Insurance companies operating within the State shall include, within the health insurance policies and related endorsements issued thereby, all healthcare services associated with Removal and Transplantation procedures provided to both the donor and the recipient before, during, and after the procedure, including treatment of any complications arising therefrom, irrespective of when such complications arise or are detected. Such companies shall bear the costs thereof under all health insurance schemes applicable within the State. In all cases, the cost of Organ Transplantation shall include the costs associated with Removal of the Organ or Tissue from either a living donor or a deceased donor, as well as the costs of post-Removal and post-Transplantation follow-up and any resulting complications, without prejudice to the provisions prescribed in the Decree by Law and this Resolution.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 12

Article (11) Conditions Governing the Consent of the Guardian or Relatives to Organ and Tissue Donation 1. Where the deceased did not express, during their lifetime, their willingness to donate, the consent of their guardian or any relative in accordance with the order of priority prescribed in Article (12) of the Decree by Law shall be obtained. Such consent shall be in writing and authenticated by one of the following methods: a. Electronic signature through the digital identity system in force within the State. b. Authentication of the consent before a Notary Public or before the embassy to which the guardian or relative is a national. c. A declaration made before the employee designated by the National Center using the prescribed form. 2. In respect of a guardian or relative residing outside the State, consent shall be given through a declaration signed by the guardian or relative according to the order of priority prescribed in Article (12) of the Decree by Law. Where it is not possible to obtain a signature, a thumbprint may suffice. In all cases, the signatures of two witnesses attesting to the validity of the consent shall be required. The National Center shall determine the appropriate method of authentication according to the circumstances of each case.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 13

Article (12) Controls Governing Removal of an Organ, Part Thereof, or Human Tissue from the Body of an Unidentified Deceased Person Without prejudice to Article (13) of the Decree by Law, Removal of an Organ, part thereof, or Tissue from the body of an unidentified deceased person shall be subject to the following conditions: 1. The National Center shall, in coordination with the competent police authority and the Public Prosecution, take all necessary measures to establish the identity of the deceased or any of the relatives referred to in Article (12) of the Decree by Law. Where any such relative is located, the procedures prescribed for the Removal of Organs from the body of a deceased Person whose identity is known shall apply. 2. Where the identity of the deceased cannot be established, and this is confirmed by a decision of the Public Prosecution, and no relative can be located as determined by the competent police authority, the National Center shall, in coordination with the Health Establishment where the deceased is located, conduct a comprehensive medical assessment to determine the deceased’s suitability for Removal, unless the circumstances of the Death are under suspicion or are the subject of a criminal investigation, in which case the approval of the Public Prosecution shall be obtained before conducting the assessment. 3. Where the deceased is found suitable for Removal, the National Center shall submit a request to the Public Prosecution to obtain approval for performing the Removal procedure, after which the legally prescribed procedures shall be completed. 4. The element of urgency shall be observed in all procedures referred to in this Article, in a manner consistent with the nature of Removal and Transplantation procedures.

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Cabinet Resolution of 2026 Regarding the Executive Regulations of Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 14

Article (13) Controls Governing Removal of an Organ, Part Thereof, or Human Tissue from the Body of a Deceased Person Involved in an Accident Without prejudice to the provisions of Articles (12) and (13) of the Decree by Law, the Removal of an Organ, part thereof, or Tissue from the body of a deceased Person involved in an accident shall be subject to the following conditions: 1. The National Center shall, immediately upon Death, verify whether the deceased had previously registered their willingness to donate. 2. The guardian or any relative of the deceased shall be contacted to obtain their consent to the Donation, unless the circumstances of the Death are under suspicion or are the subject of a criminal investigation, in which case the approval of the Public Prosecution shall be obtained before performing the Removal procedure.