1. Approval for the destruction or safe disposal of Medical Products shall be issued by the Competent Health Establishment or Authority, each within the limits of its jurisdiction in accordance with the following conditions: a. The Applicant shall be a Establishment licensed by the EDE, Ministry, or Competent Health Authority, or any other Establishment that has been issued approval by the EDE to import Medical Products. b. The Application meets the requirements of the environmental legislation in force in this regard. c. The Application shall include a specification of the licensed entity inside or outside the State that will carry out the process of destroying and safely disposing of the products in accordance with medical conditions. d. The Application shall be accompanied by the necessary documents to ensure that the destruction or disposal process is tracked and that it is consistent with the general rules issued by the EDE in this regard, including records of the quantities of the Medical Product to be disposed of and the method of its safe disposal. e. Obtaining any other necessary approvals from the relevant authorities in the State if the materials or products to be destroyed or disposed of are chemical precursors or controlled, semi-controlled, hazardous or toxic products and materials, whether intended for human or veterinary use. f. Fulfilling other conditions and controls for disposing of Medical Products in accordance with their type, in accordance with what is specified in the Executive Regulations of this Decree-Law. 2. The Entity referred to in paragraph (C) of Clause (1) of this Article shall be obligated to ensure that the disposal methods followed by it comply with the applicable legislation and general rules issued by the EDE in this regard, and in a manner that ensures that they do not harm the environment and public health. 3. The Competent Health Authorities may add any other conditions related to their specializations. 4. If the approval for destruction is issued by the Competent Health Authority, a periodic report shall be submitted to the EDE, including the reasons, mechanism, and date of destruction, and the quantity and type of destroyed materials.
Interpretation and application must be checked against the official text and current version.